Dry Eye SyndromesPhase 3NCT02965846

Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye

A Phase 3 study testing AGN-195263 in people with Dry Eye Syndromes, run by Allergan at 49 sites in 12 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The objectives of this study are twofold •To evaluate the safety and efficacy of 0.1% AGN-195263 administered twice daily compared to its vehicle in patients with evaporative dry eye (EDE) •To evaluate the systemic pharmacokinetics of 0.1% AGN-195263 administered twice daily in patients with EDE Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dry Eye Syndromes
What is being tested?: AGN-195263
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 43 participants
Where: 49 sitesin 12 countries
Study dates: 13 Dec 2016to 13 Jun 2017
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male, 18 years of age or older, at the screening (day -51) visit OR
Females, who are naturally postmenopausal (permanent cessation of menstrual periods for at least 12 consecutive months) or are permanently sterilized (ie, eg, tubal occlusion,hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy) at the screening (day -51) visit
In at least 1 eye, all of the following objective measures of evaporative dry eye (EDE) must be present at the standardization (day -21) and baseline (day 1) visits. The same eye must qualify at both visits
Tear film break-up time (TBUT) ≥ 2 seconds and ≤ 7 seconds
Corneal sodium fluorescein staining score ≥ 1 and ≤ 4 (Oxford scheme)
Anesthetized Schirmer's tear test score ≥ 10 mm after 5 minutes

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At the standardization (day -21) and baseline (day 1) visits, patients must have:
Ocular Surface Disease Index© (OSDI) score > 12 (0 to 100 scale)
Overall ocular discomfort score ≥ 1 and < 4 (0 to 4 scale; 0 = none, 4 = very severe)
Ocular burning score ≥ 1 and < 4 (0 to 4 scale; 0 = none, 4 = very severe)
Blurred vision score ≥ 1 and < 4 (0 to 4 scale; 0 = none, 4 = very severe)
In at least 1 eye, a lower lid margin meibum quality global assessment score ≥ 1 at the standardization (day -21) and baseline (day 1) visits. The same eye must qualify at both visits
In at least 1 eye, the number of lower lid margin expressible meibomian glands must be ≥ 3 at the standardization (day -21) and baseline (day 1) visits. The same eye must qualify at both visits
Use of an artificial tear product, lid hygiene (ie, warm compress, lid massage, lid scrub), omega-3 supplementation (topical ocular or systemic), or antibiotics (ie, systemic or topical macrolides, tetracyclines, tetracycline derivatives [including doxycycline and minocycline]) for the treatment of dry eye disease, or meibomian gland disease within 1 year of the standardization (day -21) visit

Who cannot join

Male patients with a history of, known, or suspected prostate cancer
Male patients with a prostate-specific antigen (PSA) level ≥ 4 μg/L
Female patients with a history of known or suspected breast, cervical, ovarian, or uterine cancer
Female patient who is of child-bearing potential
At standardization (day -21) and / or baseline (day 1) visits, a lower lid margin meibum quality global assessment score of non-expressible (NE) in either eye
Patients who are currently using estrogen and/or progesterone containing products (including herbal and nutritional supplements) and not on a stable dose (at least 90 days prior to the standardization visit (day -21) and/or anticipate initiating use and/or changing use during the study

Show all 10Show fewer

Patients who are currently using or have used any androgen or anti-androgen treatment (including herbal and nutritional supplements), within 90 days of the standardization (day -21) visit or anticipated use during the study
Patients who are currently using or have used any hair growth product within 90 days of the standardization (day -21) visit or anticipated use during the study
Patients who are currently using or have used topical corticosteroids in the eyes or on the eyelids within 60 days prior to the standardization visit (day -21), or any such use anticipated prior to the month 6 visit
Patients who are currently using or have used oral or topical macrolides, tetracyclines, tetracycline derivative drugs (including doxycycline and minocycline), retinoids (eg, isotretinoin), calcineurin inhibitors (ie, RESTASIS®, Ikervis®), oral (systemic) corticosteroids, or lifitegrast (Xiidra™) or any other therapeutic dry eye treatment within 60 days of the standardization visit (day -21), or anticipated use before the month 6 visit

Trial locations and contacts

49 sites in 12 countries.

Country

City, postcode or hospital

49 sites in 12 countries

United States8 sites

Sall Research Medical Center
Artesia, California, 90701
Lifelong Vision Foundation
Chesterfield, Missouri, 63017
Scott and Christie Associates
Cranberry Township, Pennsylvania, 16066
Lugene Eye Institute
Glendale, California, 91204
Piedmont Eye Center
Lynchburg, Virginia, 24502
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
Devers Eye Institute
Portland, Oregon, 97210
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240

Other trials in United States

Germany6 sites

University Hospital of Cologne, Dept of Ophthalmology
Cologne, 50937
Augenklinik Universitatsklinikum
Düsseldorf, 40225
University Eye Hospital
Freiburg im Breisgau, 79106
Gutenberg University Medical School, Dept of Ophthalmology
Mainz, 55131
Ludwig-Maximilians-University, Dept of Ophthalmology
Munich, 80366
St. Franziskus Hospital Augenabteilung
Münster, 48145

Other trials in Germany

Spain6 sites

Institto de Microcirugia Ocular C/Josep Maria Llado
Barcelona, 08035
Clinico de Barcelona Casa de la Maternidad
Barcelona, 8028
Clinica Oftalmologica
Huelva, 21004
Instituto Oftalmologico Fernandez-Vega
Oviedo, Principado de Asturias, 33012
Cartuja Vision
Seville, 41003
University of Valladolid, Facultad Medicina
Valladolid, 47005

Other trials in Spain

Italy5 sites

Rapallo Hospital, Opthalmology Department
Genova, 16035
Istituto di Oftalmologia
Messina, 98122
Ospedale San Giuseppe, Universita di Milano
Milan, 20123
Istituto Di Ricovero E Cura A Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)
Milan, 20132
University of Pisa, Neurosciences - Section of Ophthalmology
Pisa, 56126

Other trials in Italy

Poland5 sites

Prywatna Klinika Okulistyczna OFTALMIKA
Bydgoszcz, 85-631
Szpital Specjalistyczny nr 1 w Bytomiu
Bytom, 41-902
Optimum Profesorskie Centrum Okulistyki
Gdansk, 80-809
Specjalistyczna Praktyka Lekarska prof. Edward Wylegala
Katowice, 43-300
Uniwersyteck Szpital Kliniczny im. Jana Mikulicza-Radeckiego
Wroclaw, 50-556

Other trials in Poland

Czechia4 sites

Fakultni nemocnice Ostrava
Ostrava, 708 52
Ocni klinika OFTEX
Pardubice, 530 02
FN Kralovske Vinohrady, Ocni Klinika
Prague, 100 34
Oční ambulance
Velká Bíteš, 595 01

Other trials in Czechia

France3 sites

CHU de Bordeaux, Service d'Ophtalmologie
Bordeaux, 33076
CHU Hopital Morvan (Bat 4) Service Daviel Ophtalmologie
Brest, 29609
CHU Limoges - Hôpital Dupuytren
Limoges, 87042

Other trials in France

Hungary3 sites

Dept. of Ophthalmology Semmelweis University
Budapest, H-1085
University of Debrecen, Dept of Opthalmology, (DE OEC Szemklinika)
Debrecen, H-4032
University of Szeged Szent-Györgyi Albert Clinical Center, Faculty of Medicine, Dept of Ophthalmology
Szeged, H-6720

Other trials in Hungary

Philippines3 sites

Asian Eye Institute
Makati City, 1200
Peregrine Eye and Laser Institute
Makati City, 1209
The Medical City
Pasig, 1605

Other trials in Philippines

Taiwan3 sites

Buddhist Tzu Chi General Hospital
Hualien City, 970
National Taiwan University Hospital
Taipei, 100
Tri-Service General Hospital
Taipei, 11447

Other trials in Taiwan

Turkey (Türkiye)2 sites

Ege Üniv. Tıp Fakültesi
Izmir, 35040
Erciyes Üniversitesi Tıp Fakültesi
Kayseri, 38039

Other trials in Turkey (Türkiye)

United Kingdom1 site

Newcastle University School of Medicine, Dept of Ophthamology
Newcastle upon Tyne, NE1 4LP

Other trials in United Kingdom

About this study

Conditions: Dry Eye Syndromes
Being tested: AGN-195263, Vehicle
Keywords: EDE, evaporative dry eye
Medical subject headings: Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AGN-195263Drug
1 drop of AGN-195263 will be instilled in each eye twice daily.
VehicleDrug
1 drop of AGN-195263 vehicle(placebo) will be instilled in each eye twice daily.

Study groups in NCT02965846
Study group	Role	What they receive
AGN-195263	Experimental	Not described Receives: Drug: AGN-195263
Vehicle	Placebo comparator	Not described Receives: Drug: Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Ocular Discomfort Score (0 to 4 Scale; 0=None, 4=Very Severe)
The overall ocular discomfort will be assessed on a questionnaire using a 0 to 4 scale on which 0=none, 1=mild, 2=moderate, 3=severe and 4=very severe.
Measured: 6 month visit

Secondary outcomes (1)

Change From Baseline in Tearfilm Break Up Time (TBUT)
For TBUT, the mean of 3 measurements of time in seconds will be computed at each visit for each eye. The mean value of the study eye will be used for the analysis.
Measured: Baseline (day 1) to 6 month visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Dec 201613 Jun 2017

First posted17 Nov 2016 (estimated)
Study start13 Dec 2016
Primary completion13 Jun 2017
Study completion13 Jun 2017

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 Dry Eye SyndromesStudies 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: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02965846
Sponsor's protocol ID: 195263-010
Status last verified: Nov 2018
First submitted: 15 Nov 2016
Last updated: 30 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dry Eye Syndromes trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye
ClinicalTrials.gov ID: NCT02965846
Acronym / sponsor ID: 195263-010
Conditions: Dry Eye Syndromes
Keywords: EDE, evaporative dry eye
Phase: Phase 3
Study type: Interventional
Recruitment status: Terminated
Enrolment: 43 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 13 Dec 2016 (actual)
Primary completion: 13 Jun 2017 (actual)
Study completion: 13 Jun 2017 (actual)
First posted: 17 Nov 2016 (estimated)
Results: Posted 30 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
AGN-195263	Experimental	Drug: AGN-195263
Vehicle	Placebo comparator	Drug: Vehicle

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Male, 18 years of age or older, at the screening (day -51) visit OR
Females, who are naturally postmenopausal (permanent cessation of menstrual periods for at least 12 consecutive months) or are permanently sterilized (ie, eg, tubal occlusion,hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy) at the screening (day -51) visit
In at least 1 eye, all of the following objective measures of evaporative dry eye (EDE) must be present at the standardization (day -21) and baseline (day 1) visits. The same eye must qualify at both visits
At the standardization (day -21) and baseline (day 1) visits, patients must have:
In at least 1 eye, a lower lid margin meibum quality global assessment score ≥ 1 at the standardization (day -21) and baseline (day 1) visits. The same eye must qualify at both visits

Key exclusion criteria (10 listed)

Male patients with a history of, known, or suspected prostate cancer
Male patients with a prostate-specific antigen (PSA) level ≥ 4 μg/L
Female patients with a history of known or suspected breast, cervical, ovarian, or uterine cancer
Female patient who is of child-bearing potential
At standardization (day -21) and / or baseline (day 1) visits, a lower lid margin meibum quality global assessment score of non-expressible (NE) in either eye

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
AGN-1952631 drop of AGN-195263 will be instilled in each eye twice daily.	Drug	AGN-195263
Vehicle1 drop of AGN-195263 vehicle(placebo) will be instilled in each eye twice daily.	Drug	Vehicle

Primary outcome

Overall Ocular Discomfort Score (0 to 4 Scale; 0=None, 4=Very Severe)
Time frame: 6 month visit
The overall ocular discomfort will be assessed on a questionnaire using a 0 to 4 scale on which 0=none, 1=mild, 2=moderate, 3=severe and 4=very severe.

1 secondary outcome

Change From Baseline in Tearfilm Break Up Time (TBUT)
Time frame: Baseline (day 1) to 6 month visit

Results and safety

Results posted to the registry on 30 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AGN-195263	5	0
Vehicle	5	0
Enrolled But Not Randomized	33	0

Primary outcome: Overall Ocular Discomfort Score (0 to 4 Scale; 0=None, 4=Very Severe)

Time frame: 6 month visit

Population analysed: Efficacy analyses including the overall ocular discomfort score were planned. Ultimately, these analyses were not performed due to the fact that the study was terminated before the primary/secondary efficacy visit could be reached.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 157 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AGN-195263	0 of 5 (0%)	0 of 5 (0%)	0 of 5
Vehicle	0 of 5 (0%)	1 of 5 (20%)	0 of 5

Limitations and caveats (from the sponsor): Due to study termination, the study was underpowered

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Dry Eye Syndromes

Not yet recruitingPhase 2
Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments
Dry Eye Disease (DED), Graft-Versus-Host Disease(GVHD)
Not yet recruiting
LacriFill Canalicular Occlusion for Dry Eye After LASIK
Dry Eye Syndrome
Active, not recruiting
Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD
Meibomian Gland Dysfunction, Dry Eye Disease
Not yet recruitingEarly Phase 1
a Novel siRNA Eyedrops for DED Treatment
Dry Eye
Recruiting
Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease
Dry Eye Disease

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.

Khristopher Hansen study director

Allergan

49 sites in 12 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AGN-195263 in people with Dry Eye Syndromes, run by Allergan at 49 sites in 12 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 14 inclusion and 10 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 30 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States, Germany, Spain, Italy, Poland and 7 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 30 Nov 2018). 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?

Overall Ocular Discomfort Score (0 to 4 Scale; 0=None, 4=Very Severe) (time frame: 6 month visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02965846.

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 30 Nov 2018; AzTrials last refreshed its copy on 8 Nov 2026.