Adenoviral ConjunctivitisPhase 3NCT02998541
Treatment of Adenoviral Conjunctivitis With SHP640 Compared to Povidone-iodine (PVP-I) and Placebo
A Phase 3 study testing SHP640 and PVP-I 0.6% in people with Adenoviral Conjunctivitis, run by Shire at 130 sites in 16 countries.
Trial summary
The purpose of this study is to determine if an investigational treatment is effective compared with placebo and PVP-Iodine in the treatment of adults and children with adenoviral conjunctivitis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adenoviral Conjunctivitis
- What is being tested?
- SHP640 and PVP-I 0.6%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 219 participants
- Where
- 130 sitesin 16 countries
- Study dates
- 27 Mar 2017to 13 May 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- An understanding, ability, and willingness to fully comply with study procedures and restrictions (by the parent(s), guardian, or legally authorized representative, if applicable).
- Ability to voluntarily provide written, signed, and dated (personally or via a parent(s), guardian, or legally authorized representative(s) informed consent (and assent, if applicable) to participate in the study.
- Participants of any age at Visit 1 (Note: participants lesser than (<) 3 months of age at Visit 1 must have been full-term, i.e. greater than or equal to (>=) 37 weeks gestational age at birth).
- Meet at least 1 of the 2 criteria below:
- Have a positive AdenoPlus test at Visit 1 in at least 1 eye. b) Have at least 2 of the following 5 criteria, based upon medical history and examination: i.Symptoms within the past 7 days consistent with acute upper respiratory tract infection (eg. sore throat, cough, rhinorrhea, etc).
- Contact within the past 7 days with family members or other individuals with recent onset of symptoms consistent with conjunctivitis iii. Acute onset within the past 4 days of one or more of the following ocular symptoms: burning/irritation, foreign body sensation, light sensitivity.
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- Enlarged periauricular lymph node(s). v. Presence of follicles on tarsal conjunctiva. Note:If the participant only meets Inclusion Criterion (a positive AdenoPlus test in at least 1 eye), then the same eye must meet the mentioned below Inclusion Criterion.
- Have a clinical diagnosis of suspected adenoviral conjunctivitis in at least 1 eye confirmed by the presence of the following minimal clinical signs and symptoms in that same eye:
- Report presence of signs and/or symptoms of adenoviral conjunctivitis for lesser than or equal to (<=) 4 days prior to Visit 1
- Bulbar conjunctival injection: a grade of >= 1 (mild) on a 0-4 Bulbar Conjunctival Injection Scale.
- Watery conjunctival discharge: a grade of >= 1 (mild) on a 0-3 Watery Conjunctival Discharge Scale
- Be willing to discontinue contact lens wear for the duration of the study.
- Have a Best Corrected Visual Acuity (BCVA) of 0.60 logMAR or better in each eye as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. BCVA will be assessed by an age appropriate method in accordance with the AAP Policy Statement for Visual System Assessment in Infants, Children, and Young Adults by Pediatricians (Donahue and Baker 2016; American Academy of Pediatrics 2016).The policy statement recommends formal vision screening can begin at 3 years of age. VA measurements for children under the age of 3 will be done at the discretion of the investigator.
- If not done, child should be able to fixate on and follow a moving object, except participants <2 months of age who have not yet developed this ability. Participants <2 months will be enrolled at the discretion of the investigator.
- Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol or females of non-childbearing potential.
Who cannot join
- Current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments, per investigator's discretion.
- Current or relevant history of physical or psychiatric illness, any medical disorder that may make the participants unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
- Have known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients.
- Prior enrollment in a FST-100 or SHP640 clinical study.
- Participants who are employees, or immediate family members of employees (who are directly related to study conduct), at the investigational site.
- Have a history of ocular surgical intervention within <= 6 months prior to Visit 1 or planned for the period of the study.
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- Have a pre-planned overnight hospitalization during the period of the study.
- Have presence of any intraocular, corneal, or conjunctival ocular inflammation (eg, uveitis, iritis, ulcerative keratitis, chronic blepharoconjunctivitis), other than adenoviral conjunctivitis.
- Have presence of corneal subepithelial infiltrates at Visit 1.
- Have active or history of ocular herpes.
- Have at enrollment or within <= 30 days of Visit 1, a clinical presentation more consistent with the diagnosis of non-infectious conjunctivitis (except presumed seasonal/perennial allergic conjunctivitis), or non-adenoviral ocular infection (e.g. bacterial, fungal, acanthamoebal, or other parasitic).
- Note:history or concomitant presence of presumed seasonal or perennial allergic conjunctivitis signs/symptoms is not exclusionary.
- Neonates or infants (i.e. participants less than 12 months of age) who have suspected or confirmed (based on the result of any test conducted prior to screening) conjunctivitis of gonococcal, chlamydial, herpetic or chemical origin.
- Neonates or infants (i.e. participants less than 12 months of age) whose birth mothers had any sexually transmitted disease within 1 month of delivery or any history of genital herpes.
- Presence of nasolacrimal duct obstruction at Visit 1 (Day 1).
- Presence of any significant ophthalmic condition (e.g. Retinopathy of Prematurity, congenital cataract, congenital glaucoma) or other congenital disorder with ophthalmic involvement that could affect study variables.
- Be a known intraocular pressure (IOP) steroid responder, have a known history or current diagnosis of glaucoma, or be a glaucoma suspect.
- Have any known clinically significant optic nerve defects.
- Have a history of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome; presence of corneal epithelial defect or any significant corneal opacity at Visit 1.
- Presence of significant, active condition in the posterior segment which requires invasive treatment (e.g. intravitreal treatment with VEGF inhibitors or corticosteroids) and may progress during the study participation period.
- Have used any topical ocular or systemic anti-vials or antibiotics within <= 7 days of enrollment.
- Have used any topical ocular Non-steroidal Anti-inflammataory Drugs (NSAIDs) within <= 1 day of enrollment.
- Have used any topical ophthalmic steroids in the last <= 14 days.
- Have used any systemic corticosteroid agents within <= 14 days of Day 1. Stable (initiated >= 30 days prior to enrollment) use of inhaled and nasal corticosteroids is allowed, given no anticipated change in dose for the duration of the study. Topical dermal steroids are allowed except in the peri-ocular area.
- Have used non-corticosteroid immunosuppressive agents within <= 14 days of Day 1.
- Have used any topical ophthalmic products, including tear substitutes, and over-the-counter preparations such as lid scrubs, within 2 hours of Visit 1 and be unable to discontinue all topical ophthalmic products for the duration of the study. Use of hot or cold compresses is also not permitted during the study.
- Have any significant ocular disease (eg, Sjogren's syndrome) or any uncontrolled systemic disease or debilitating disease (eg, cardiovascular disease, hypertension, sexually transmitted diseases/infections, diabetes or cystic fibrosis), that may affect the study parameters, per the investigator's discretion.
- Any known history of immunodeficiency disorder or known active conditions predisposing to immunodeficiency, such as human immunodeficiency virus, hepatitis B or C, evidence of active hepatitis A (antihepatitis A virus immunoglobulin M), or organ or bone marrow transplantation.
- Within 30 days prior to the first dose of investigational product:
- Have used an investigational product or device, or
- Have been enrolled in a clinical study (including vaccine studies) that, in the investigator's opinion, may impact this Shire-sponsored study
Trial locations and contacts
130 sites in 16 countries.
130 sites in 16 countries
United States68 sites
The Regents of the University of Michigan
Ann Arbor, Michigan, 48105
Milton M. Hom, OD, FAAO
Azusa, California, 91702
Eye Center Northeast
Bangor, Maine, 04401
Hassman Research Institute
Berlin, New Jersey, 08009
Minnesota Eye Consultants, P.A.
Bloomington, Minnesota, 55431
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
The Eye Associates
Bradenton, Florida, 34209
Arizona Eye Center
Chandler, Arizona, 85224
Lifelong Vision Foundation
Chesterfield, Missouri, 63017
Ericksen Research & Development, LLC
Clinton, Utah, 84015
Matossian Eye Associates
Doylestown, Pennsylvania, 18902
MediSphere Medical Research Center, an AMR affiliate
Evansville, Indiana, 47714
Emerson Clinical Research Institute, LLC
Falls Church, Virginia, 22046
South Florida Vision Associates, LLC
Fort Lauderdale, Florida, 33309
Midwestern University Eye Institute
Glendale, Arizona, 85308
Mark B. Kislinger, MD, PhD, Inc.
Glendora, California, 91741
Lakeview Vision - Gretna
Gretna, Louisiana, 70056
Inland Eye Specialists
Hemet, California, 92545
Houston Eye Associates
Houston, Texas, 77025
Lakeside Vision Center
Irvine, California, 92604
Moyes Eye Center
Kansas City, Missouri, 64154
Jackson Eye
Lake Villa, Illinois, 60046
Lake Travis Eye & Laser Center
Lakeway, Texas, 78734
Nevada Eye Care Professionals
Las Vegas, Nevada, 89129
Houston Eye Associates
League City, Texas, 77573
Koffler Vision Group
Lexington, Kentucky, 40509
Kentucky Eye Institute
Lexington, Kentucky, 40517
Shire Call Center
Lexington, Massachusetts, 02421
Loma Linda University
Loma Linda, California, 92354
Eye Physicians of Long Beach
Long Beach, California, 90808
Oxford Optical
Los Angeles, California, 90020
Macy Eye Center
Los Angeles, California, 90048
Senior Health Services
Louisville, Kentucky, 40220
University of Wisconsin
Madison, Wisconsin, 53705
The Eye Center at Southern College of Optometry
Memphis, Tennessee, 38104
Total Eye Care, PA
Memphis, Tennessee, 38119
Eye Specialty Group
Memphis, Tennessee, 38120
Bascom Palmer Eye Institute
Miami, Florida, 33136
Lorites Medical Group
Miami, Florida, 33166
DCT-Shah Research, LLC dba Discovery Clinical Trials
Mission, Texas, 78572
Eye Care Centers Management, Inc.
Morrow, Georgia, 30260
Nashville Vision Associates
Nashville, Tennessee, 37205
Toyos Clinic
Nashville, Tennessee, 37215
Shultz Chang Vision
Northridge, California, 91325
Pediatric & Adult Research Center, LLC
Orlando, Florida, 32825
Baker, Carl W
Paducah, Kentucky, 42001
Stanford Byers Eye Institute
Palo Alto, California, 94303
Illinois Eye Center
Peoria, Illinois, 61615
North Bay Eye Associates, Inc.
Petaluma, California, 94954
Kannarr Eye Care
Pittsburg, Kansas, 66762
UPMC Eye Center
Pittsburgh, Pennsylvania, 15213
Arch Health Partners
Poway, California, 92064
M&M Eye Institute
Prescott, Arizona, 86301
Oculus Research
Raleigh, North Carolina, 27603
Martel Eye Medical Group
Rancho Cordova, California, 95670
Black Hills Regional Eye Institute
Rapid City, South Dakota, 59101
Shasta Eye Medical Group, Inc.
Redding, California, 96002
R and R Eye Research, LLC.
San Antonio, Texas, 78229
Northern New Jersey Eye Institute
South Orange, New Jersey, 07079
Mercy Research
Springfield, Missouri, 65806
East Florida Eye Institute
Stuart, Florida, 34494
Lone Star Eye Care, P.A.
Sugar Land, Texas, 77479
Walman Eye Center
Sun City, Arizona, 85351
Andrew Gardner Logan, MD / dba Logan Ophthalmic Research, LLC
Tamarac, Florida, 33321
Haik Humble Eye Center
West Monroe, Louisiana, 71291
Clinical Eye Research of Boston
Winchester, Massachusetts, 02114
James Branch, M.D.
Winston-Salem, North Carolina, 27101
Wyomissing Optometric Center
Wyomissing, Pennsylvania, 19610
India12 sites
Sankara Eye Hospital
Bangalore, Karnataka, 560037
Bhagwan Mahaveer Jain Hospital
Bangalore, Karnataka, 560052
M. S. Ramaiah Medical College and Hospital
Bangalore, Karnataka, 560054
Sapthagiri Hospital
Bangalore, Karnataka, 560090
K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre
Belagavi, Karnataka, 590010
S. P. Medical College & Associated Group of Hospitals
Bikaner, Rajasthan, 334003
L. V. Prasad Eye Institute
Hyderabad, Andhra Pradesh, 500034
Regional Institute of Ophthalmology
Kolkata, West Bengal, 700073
NKP Salve Institute of Medical Sciences
Nagpur, Maharashtra, 440025
Dr. D. Y. Patil Medical College
Navi Mumbai, Maharashtra, 400706
ICARE Eye Hospital and Post Graduate Institute
Noida, Uttar Pradesh, 201301
PBMA'S H. V. Desai Eye Hospital
Pune, Maharashtra, 411060
Spain10 sites
Complejo Asistencial Universitario de Burgos
Burgos, 9006
Hospital Universitari de Girona Dr Josep Trueta
Girona, 17001
Clinica Oftalmologia Gil Piña
Huelva, 21002
Clinica Rementeria
Madrid, 28010
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, 28222
Instituto Oftalmológico Fernández-Vega
Oviedo, Principality of Asturias, 33012
Cartuja Vision
Seville, 41092
FISABIO-Oftalmología Médica
Valencia, 46015
Hospital Clinico Universitario Lozano Blesa
Zaragoza, 50009
Hospital Universitario Miguel Servet
Zaragoza, 50009
Israel7 sites
HaEmek Medical Center
Afula, 18341
Soroka University Medical Center
Beersheba, 84101
Rambam MC
Haifa, 3109601
Shaare Zedek Medical Center
Jerusalem, 9103102
Rabin Medical Center-Beilinson Campus
Petah Tikva, 49100
Kaplan Medical Center
Rehovot, 76100
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Hungary5 sites
Debreceni Egyetem
Debrecen, 4032
Bugat Pal Korhaz
Gyöngyös, Heves County, 3200
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvár, 7400
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, Csongrád megye, 6720
Csolnoky Ferenc Korhaz
Veszprém, 8200
Poland5 sites
Szpital Specjalistyczny nr 1
Bytom, 41-902
Centrum Medyczne UNO-MED
Krakow, 31-070
Centrum Diagnostyki i Mikrochirurgii Oka LENS
Olsztyn, 10-424
Centrum Medyczne Uno-Med (Private Practice)
Tarnów, 33-100
Retina Sp. z o.o.
Warsaw, 01 -364
South Africa4 sites
Nelson R Mandela School of Medicine Ophthalmology Department
Durban, KwaZulu-Natal, 4001
Newtown Clinical Research
Johannesburg, Gauteng, 2113
Into Research
Pretoria, Gauteng, 0181
Pretoria Eye Institute Research Foundation
Pretoria, Gauteng, 83
Austria3 sites
Kepler Universitätsklinikum
Linz, 4020
AKH - Medizinische Universitaet Wien
Vienna, 1090
Vienna Institute for Research in Ocular Surgery
Vienna, 1140
Canada3 sites
McGill University Health Centre/Glen Site / Royal Victoria Hospital
Montreal, Quebec, H4A 3S5
The Ottawa Hospital - General Campus, University of Ottawa Eye Institute
Ottawa, Ontario, K1H 8L6
University of Waterloo School of Optometry and Vision Science
Waterloo, Ontario, N2L 3G1
Estonia3 sites
Eye Clinic Dr Kirsta Turman
Tallinn, 10120
East Tallinn Central Hospital
Tallinn, 10138
Tartu University Hospital
Tartu, 51010
Peru3 sites
Instituto Regional de Oftalmología
La Libertad, 13007
Macula D&T S.R.L.
Lima, 27
Oftalmosalud SRL.
Lima, 27
France2 sites
CHU Limoges - Hopital Dupuytren
Limoges, Haute Vienne, 87042
Hopital Necker - Enfants Malades
Paris, 75015
Germany2 sites
Klinisches Studienzentrum der Augenklinik
Mainz, 55131
Augenärzte am Franziskus Hospital
Münster, 48145
Australia1 site
University of the Sunshine Coast Clinical Trials Centre
Sippy Downs, Queensland, 4556
United Kingdom1 site
Manchester Royal Eye Hospital
Manchester, Greater Manchester, M139WL
About this study
Official title: A Phase 3, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of SHP640 (PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension Compared to PVP-Iodine and Placebo in the Treatment of Adenoviral Conjunctivitis
The purpose of this study is to determine if an investigational treatment is effective compared with placebo and PVP-Iodine in the treatment of adults and children with adenoviral conjunctivitis.
- Conditions
- Adenoviral Conjunctivitis
- Being tested
- SHP640, PVP-I 0.6%, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHP640Drug
Also called FST-100
Participants will receive one drop of SHP640 (0.1 % dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye QID (with a minimum of 2 hours between doses) for 7 days.
PVP-I 0.6%Drug
Participants will receive one drop of PVP-I ophthalmic solution in each eye QID (with a minimum of 2 hours between doses) for 7 days.
PlaceboOther
Participants will receive one drop of placebo ophthalmic solution in each eye QID (with a minimum of 2 hours between doses) for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| SHP640 | Experimental | Participants will receive one drop of SHP640 (0.1 percent [%] dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye 4 times daily (QID) for 7 days. Receives: Drug: SHP640 |
| PVP-I 0.6% | Active comparator | Participants will receive one drop of 0.6% PVP-I ophthalmic solution in each eye QID for 7 days. Receives: Drug: PVP-I 0.6% |
| Placebo | Placebo comparator | Participants will receive one drop of placebo ophthalmic solution in each eye QID for 7 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on Day 6
Clinical resolution of adenoviral conjunctivitis was defined as the absence (score=0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her cell culture-immunofluorescence assay (CC-IFA) results at baseline. Bulbar conjunctival injection was assessed based on a 0 (Normal conjunctival vascular pattern)-4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge was assessed based on a 0-3 scale (0 - None and 3 - Severe: Abundant quantity of watery discharge observed in the lower conjunctival fornix and in the lower lid margin). Higher score represent worse symptoms for both scores. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.
Measured: Day 6
Secondary outcomes (15)
Number of Participants With Clinical Resolution Among Who Received SHP640 or Povidone-Iodine (PVP-I) on Day 6
Clinical resolution of adenoviral conjunctivitis was defined as the absence (score=0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Bulbar conjunctival injection was assessed based on a 0 (Normal conjunctival vascular pattern)-4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge was assessed based on a 0-3 scale (0 - None and 3 - Severe: Abundant quantity of watery discharge observed in the lower conjunctival fornix and in the lower lid margin). Higher score represent worse symptoms for both scores. Data analysis was performed in SHP640 and PVP-I 0.6% reporting groups only but not in placebo.
Measured: Day 6
Number of Participants With Clinical Resolution Among Who Received Povidone-Iodine (PVP-I) or Placebo on Day 6
Clinical resolution of adenoviral conjunctivitis was defined as the absence (score=0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Bulbar conjunctival injection was assessed based on a 0 (Normal conjunctival vascular pattern)-4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge was assessed based on a 0-3 scale (0 - None and 3 - Severe: Abundant quantity of watery discharge observed in the lower conjunctival fornix and in the lower lid margin). Higher score represent worse symptoms for both scores. Data analysis was performed in PVP-I 0.6% and placebo reporting groups only but not in SHP640.
Measured: Day 6
Number of Participants With Adenoviral Eradication Among Who Received Povidone-Iodine (PVP-I) or Placebo on Day 3
Adenoviral eradication for the study eye was defined as negative Cell Culture- Immunofluorescence Assay (CC-IFA) in that eye. CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Data analysis was performed in PVP-I 0.6% and placebo reporting groups only but not in SHP640.
Measured: Day 3
Number of Participants With Adenoviral Eradication Among Who Received SHP640 or Placebo on Day 6
Adenoviral eradication for the study eye was defined as negative CC-IFA in that eye. CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.
Measured: Day 6
Number of Participants With Adenoviral Eradication Among Who Received SHP640 or Povidone-Iodine (PVP-I) on Day 6
Adenoviral eradication for the study eye was defined as negative CC-IFA in that eye. CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Data analysis was performed in SHP640 and PVP-I 0.6% reporting groups only but not in placebo.
Measured: Day 6
Percent Change From Baseline in Adenovirus Viral Titer as Assessed by Quantitative Polymerase Chain Reaction (qPCR) at Day 6 and 8
qPCR test was performed on all CC-IFA positive samples at all visits to determine viral count in the study eye. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Percent (%) change from baseline in adenovirus viral titer as assessed by qPCR was reported.
Measured: Day 6 and 8
Number of Participants With Adenoviral Eradication on Day 8 and 12/Early Termination (ET)
Adenoviral eradication for the study eye was defined as negative CC-IFA in that eye. CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.
Measured: Day 8 and 12/ET
Number of Participants With Clinical Resolution on on Day 3, 8 and 12/Early Termination (ET)
Clinical resolution of adenoviral conjunctivitis was defined as the absence (score=0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Bulbar conjunctival injection was assessed based on a 0 (Normal conjunctival vascular pattern)-4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge was assessed based on a 0-3 scale (0 - None and 3 - Severe: Abundant quantity of watery discharge observed in the lower conjunctival fornix and in the lower lid margin). Higher score represent worse symptoms for both scores.
Measured: Day 3, 8 and 12/ET
Change From Baseline in Individual Clinical Signs Score at Day 3, 6, 8 and 12/Early Termination (ET)
The Individual clinical signs score (bulbar conjunctival injection and watery conjunctival discharge) in the study were reported. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CCIFA results at baseline.
Measured: Day 3, 6, 8 and 12/ET
Number of Participants With at Least 2 Point Reduction From Baseline in the Global Clinical Score at Day 3, 6, 8 and 12/Early Termination (ET)
Global clinical score was the sum of bulbar conjunctival injection and watery conjunctival discharge. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.
Measured: Day 3, 6, 8 and 12/ET
Number of Participants With Modified Clinical Resolution on Day 3, 6, 8 and 12/Early Termination (ET)
Modified clinical resolution was defined as a global clinical score of 0 or 1. Global clinical score was the sum of bulbar conjunctival injection and watery conjunctival discharge. The study eyewas defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.
Measured: Day 3, 6, 8 and 12/ET
Number of Participants With Expanded Clinical Resolution on Day 3, 6, 8 and 12/Early Termination (ET)
Expanded clinical resolution was defined as a global clinical score of 0, 1, or 2 with neither injection nor discharge having a score of 2. Global clinical score was the sum of bulbar conjunctival injection and watery conjunctival discharge. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.
Measured: Day 3, 6, 8 and 12/ET
Number of Participants With Status of Cross-over Infection on Day 3, 6, 8 and 12/Early Termination (ET)
Number of participants with status of cross-over infection to a participant's fellow eye. Participants with only 1 infected eye at baseline were reported.
Measured: Day 3, 6, 8 and 12/ET
Time to Clinical Resolution on Day 3, 6, 8 and 12/Early Termination (ET)
Time to clinical resolution were reported based on the assessments in the study eye.
Measured: Day 3, 6, 8 and 12/ET
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs) of SHP640
An Adverse Event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A SAE was any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect, is an important medical event. Any AE that occured after the first dose of IP instillation was considered a TEAE.
Measured: From start of the study up to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study start27 Mar 2017
- Primary completion13 May 2019
- Study completion13 May 2019
Why it stopped: Sponsor decision, unrelated to safety
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adenoviral ConjunctivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998541
- Sponsor's protocol ID
- SHP640-301
- Other IDs
- 2016-002439-14, 2016
- Status last verified
- May 2021
- First submitted
- 16 Dec 2016
- Last updated
- 14 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of SHP640 (PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension Compared to PVP-Iodine and Placebo in the Treatment of Adenoviral Conjunctivitis
- ClinicalTrials.gov ID
- NCT02998541
- Acronym / sponsor ID
- SHP640-301
- Conditions
- Adenoviral Conjunctivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision, unrelated to safety
- Enrolment
- 219 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 13 May 2019 (actual)
- Study completion
- 13 May 2019 (actual)
- First posted
- 20 Dec 2016 (estimated)
- Results
- Posted 27 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if an investigational treatment is effective compared with placebo and PVP-Iodine in the treatment of adults and children with adenoviral conjunctivitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SHP640 | Experimental | Drug: SHP640Participants will receive one drop of SHP640 (0.1 percent [%] dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye 4 times daily (QID) for 7 days. |
| PVP-I 0.6% | Active comparator | Drug: PVP-I 0.6%Participants will receive one drop of 0.6% PVP-I ophthalmic solution in each eye QID for 7 days. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will receive one drop of placebo ophthalmic solution in each eye QID for 7 days. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- An understanding, ability, and willingness to fully comply with study procedures and restrictions (by the parent(s), guardian, or legally authorized representative, if applicable).
- Ability to voluntarily provide written, signed, and dated (personally or via a parent(s), guardian, or legally authorized representative(s) informed consent (and assent, if applicable) to participate in the study.
- Participants of any age at Visit 1 (Note: participants lesser than (<) 3 months of age at Visit 1 must have been full-term, i.e. greater than or equal to (>=) 37 weeks gestational age at birth).
- Meet at least 1 of the 2 criteria below:
- Contact within the past 7 days with family members or other individuals with recent onset of symptoms consistent with conjunctivitis iii. Acute onset within the past 4 days of one or more of the following ocular symptoms: burning/irritation, foreign body sensation, light sensitivity.
Key exclusion criteria (31 listed)
- Current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments, per investigator's discretion.
- Current or relevant history of physical or psychiatric illness, any medical disorder that may make the participants unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
- Have known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients.
- Prior enrollment in a FST-100 or SHP640 clinical study.
- Participants who are employees, or immediate family members of employees (who are directly related to study conduct), at the investigational site.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHP640Also: FST-100Participants will receive one drop of SHP640 (0.1 % dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye QID (with a minimum of 2 hours between doses) for 7 days. | Drug | SHP640 |
| PVP-I 0.6%Participants will receive one drop of PVP-I ophthalmic solution in each eye QID (with a minimum of 2 hours between doses) for 7 days. | Drug | PVP-I 0.6% |
| PlaceboParticipants will receive one drop of placebo ophthalmic solution in each eye QID (with a minimum of 2 hours between doses) for 7 days. | Other | Placebo |
Primary outcome
Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on Day 6
Time frame: Day 6
Clinical resolution of adenoviral conjunctivitis was defined as the absence (score=0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her cell culture-immunofluorescence assay (CC-IFA) results at baseline. Bulbar conjunctival injection was assessed based on a 0 (Normal conjunctival vascular pattern)-4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge was assessed based on a 0-3 scale (0 - None and 3 - Severe: Abundant quantity of watery discharge observed in the lower conjunctival fornix and in the lower lid margin). Higher score represent worse symptoms for both scores. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.
15 secondary outcomes
Number of Participants With Clinical Resolution Among Who Received SHP640 or Povidone-Iodine (PVP-I) on Day 6
Time frame: Day 6
Number of Participants With Clinical Resolution Among Who Received Povidone-Iodine (PVP-I) or Placebo on Day 6
Time frame: Day 6
Number of Participants With Adenoviral Eradication Among Who Received Povidone-Iodine (PVP-I) or Placebo on Day 3
Time frame: Day 3
Number of Participants With Adenoviral Eradication Among Who Received SHP640 or Placebo on Day 6
Time frame: Day 6
Number of Participants With Adenoviral Eradication Among Who Received SHP640 or Povidone-Iodine (PVP-I) on Day 6
Time frame: Day 6
Percent Change From Baseline in Adenovirus Viral Titer as Assessed by Quantitative Polymerase Chain Reaction (qPCR) at Day 6 and 8
Time frame: Day 6 and 8
Number of Participants With Adenoviral Eradication on Day 8 and 12/Early Termination (ET)
Time frame: Day 8 and 12/ET
Number of Participants With Clinical Resolution on on Day 3, 8 and 12/Early Termination (ET)
Time frame: Day 3, 8 and 12/ET
Change From Baseline in Individual Clinical Signs Score at Day 3, 6, 8 and 12/Early Termination (ET)
Time frame: Day 3, 6, 8 and 12/ET
Number of Participants With at Least 2 Point Reduction From Baseline in the Global Clinical Score at Day 3, 6, 8 and 12/Early Termination (ET)
Time frame: Day 3, 6, 8 and 12/ET
Number of Participants With Modified Clinical Resolution on Day 3, 6, 8 and 12/Early Termination (ET)
Time frame: Day 3, 6, 8 and 12/ET
Number of Participants With Expanded Clinical Resolution on Day 3, 6, 8 and 12/Early Termination (ET)
Time frame: Day 3, 6, 8 and 12/ET
Number of Participants With Status of Cross-over Infection on Day 3, 6, 8 and 12/Early Termination (ET)
Time frame: Day 3, 6, 8 and 12/ET
Time to Clinical Resolution on Day 3, 6, 8 and 12/Early Termination (ET)
Time frame: Day 3, 6, 8 and 12/ET
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs) of SHP640
Time frame: From start of the study up to Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
130 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SHP640 and PVP-I 0.6% in people with Adenoviral Conjunctivitis, run by Shire at 130 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 130 sites in United States, India, Spain, Israel, Hungary and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on Day 6 (time frame: Day 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.