Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye
NCT ID: NCT02815293
Last Updated: 2019-02-19
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
36 participants
INTERVENTIONAL
2016-09-30
2017-06-21
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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AGN-195263
AGN-195263
1 drop of AGN-195263 will be instilled in each eye twice daily.
Vehicle
Vehicle
1 drop of AGN-195263 vehicle (placebo) will be instilled in each eye twice daily.
Interventions
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AGN-195263
1 drop of AGN-195263 will be instilled in each eye twice daily.
Vehicle
1 drop of AGN-195263 vehicle (placebo) will be instilled in each eye twice daily.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Allergan
Locations
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Arizona Eye Center
Chandler, Arizona, United States
Clearsight
Fullerton, California, United States
Orange County Ophthalmology Medical Group
Garden Grove, California, United States
Montebello Medical Center, Inc.
Montebello, California, United States
Eye Research Foundation
Newport Beach, California, United States
North Bay Eye Associates
Petaluma, California, United States
Martel Eye Medical Group
Rancho Cordova, California, United States
Centennial Eye and Cosmetic Associates
Centennial, Colorado, United States
Specialty Eye Care
Parker, Colorado, United States
Argus Research at Cape Coral Eye Center
Cape Coral, Florida, United States
Sarasota Retina Institute
Sarasota, Florida, United States
Eye Care Centers Management, Inc. dba Clayton Eye Center
Morrow, Georgia, United States
Taustine Eye Center
Louisville, Kentucky, United States
Eye Doctors of Washington
Chevy Chase, Maryland, United States
Mercy Medical Research Institute
Springfield, Missouri, United States
Ophthalmology Consultants, Ltd
St Louis, Missouri, United States
Comprehensive Eye Care
Washington, Missouri, United States
Cornerstone Eye Care, LLC
High Point, North Carolina, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Carolina Macula and Retina
Mt. Pleasant, South Carolina, United States
Nashville Vision Associates, LLC
Nashville, Tennessee, United States
Robert Cizik Eye Clinic
Houston, Texas, United States
Houston Eye Associates
Kingwood, Texas, United States
Brazosport Eye Institute
Lake Jackson, Texas, United States
The Eye Clinic of Texas, an affiliate of Houston Eye Associates
League City, Texas, United States
DCT- Shah Research, LLC dba Discovery Clinical Trials
Mission, Texas, United States
R and R Eye Research, LLC
San Antonio, Texas, United States
Stacy R. Smith, M.D., P.C.
Salt Lake City, Utah, United States
The Eye Centers of Racine and Kenosha
Racine, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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195263-009
Identifier Type: -
Identifier Source: org_study_id
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