Dry Eye SyndromesPhase 3NCT02815293
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 29 sites in United States.
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
- 36 participants
- Where
- 29 sitesUnited States
- Study dates
- 30 Sep 2016to 21 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
Show all 14Show fewer
- 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 or lid hygiene (ie, warm compress, lid massage, lid scrub) for the treatment of dry eye disease, EDE 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 or have used hormone replacement therapy or estrogen and /or progesterone based products (including herbal and nutritional supplements) within 90 days of the standardization (day -21) visit or anticipated 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 corticosteroids administered via any route within 30 days prior to the standardization (day -21) visit, or any anticipated use via any route of administration prior to the month 6 visit
- Patients who are currently using or have used oral or topical macrolides, tetracycline, tetracycline derivative drugs (including doxycycline and minocycline), retinoids (eg, isotretinoin), or calcineurin inhibitors (ie, RESTASIS®, Ikervis®) within 60 days of the standardization (day -21) visit, or anticipated use prior to the month 6 visit
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Argus Research at Cape Coral Eye Center
Cape Coral, Florida, 33904
Centennial Eye and Cosmetic Associates
Centennial, Colorado, 80016
Arizona Eye Center
Chandler, Arizona, 85225
Eye Doctors of Washington
Chevy Chase, Maryland, 20815
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Clearsight
Fullerton, California, 92835
Orange County Ophthalmology Medical Group
Garden Grove, California, 92843
Cornerstone Eye Care, LLC
High Point, North Carolina, 27262
Robert Cizik Eye Clinic
Houston, Texas, 77030
Houston Eye Associates
Kingwood, Texas, 77339
Brazosport Eye Institute
Lake Jackson, Texas, 77566
The Eye Clinic of Texas, an affiliate of Houston Eye Associates
League City, Texas, 77573
Taustine Eye Center
Louisville, Kentucky, 40217
DCT- Shah Research, LLC dba Discovery Clinical Trials
Mission, Texas, 78572
Montebello Medical Center, Inc.
Montebello, California, 90640
Eye Care Centers Management, Inc. dba Clayton Eye Center
Morrow, Georgia, 30260
Carolina Macula and Retina
Mt. Pleasant, South Carolina, 29464
Nashville Vision Associates, LLC
Nashville, Tennessee, 37205
Eye Research Foundation
Newport Beach, California, 92663
Specialty Eye Care
Parker, Colorado, 80134
North Bay Eye Associates
Petaluma, California, 94954
The Eye Centers of Racine and Kenosha
Racine, Wisconsin, 53405
Martel Eye Medical Group
Rancho Cordova, California, 95670
Stacy R. Smith, M.D., P.C.
Salt Lake City, Utah, 84117
R and R Eye Research, LLC
San Antonio, Texas, 78229
Sarasota Retina Institute
Sarasota, Florida, 34239
Mercy Medical Research Institute
Springfield, Missouri, 65804
Ophthalmology Consultants, Ltd
St Louis, Missouri, 63131
Comprehensive Eye Care
Washington, Missouri, 63090
About this study
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
- 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 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 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.
- First posted28 Jun 2016 (estimated)
- Study start30 Sep 2016
- Primary completion21 Jun 2017
- Study completion21 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02815293
- Sponsor's protocol ID
- 195263-009
- Status last verified
- Feb 2019
- First submitted
- 24 Jun 2016
- Last updated
- 19 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. 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
- NCT02815293
- Acronym / sponsor ID
- 195263-009
- Conditions
- Dry Eye Syndromes
- Keywords
- EDE, evaporative dry eye
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 36 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2016 (actual)
- Primary completion
- 21 Jun 2017 (actual)
- Study completion
- 21 Jun 2017 (actual)
- First posted
- 28 Jun 2016 (estimated)
- Results
- Posted 19 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Medical Director study director
Allergan
29 sites in 1 country: 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 29 sites in United States.
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 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States. 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 19 Feb 2019). 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?
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 19 Feb 2019.