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

Phase 3

Terminated

Conditions: Dry Eye Syndromes

Interventions: Drug: Vehicle
Drug: AGN-195263

Registration Number: NCT02815293

Lead Sponsor: Allergan

Brief 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

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 36

Inclusion Criteria

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
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 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
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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle	Vehicle	-
AGN-195263	AGN-195263	-

Primary Outcome Measures

Name	Time	Method
Overall Ocular Discomfort Score (0 to 4 Scale; 0=None, 4=Very Severe)	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.

Secondary Outcome Measures

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

Trial Locations

Locations (29): Eye Doctors of Washington
🇺🇸
Chevy Chase, Maryland, United States
Eye Research Foundation
🇺🇸
Newport Beach, California, United States
Eye Care Centers Management, Inc. dba Clayton Eye Center
🇺🇸
Morrow, Georgia, United States
Taustine Eye Center
🇺🇸
Louisville, Kentucky, United States
Brazosport Eye Institute
🇺🇸
Lake Jackson, Texas, United States
Ophthalmology Consultants, Ltd
🇺🇸
Saint Louis, Missouri, United States
North Bay Eye Associates
🇺🇸
Petaluma, California, United States
Centennial Eye and Cosmetic Associates
🇺🇸
Centennial, Colorado, United States
Robert Cizik Eye Clinic
🇺🇸
Houston, Texas, United States
Argus Research at Cape Coral Eye Center
🇺🇸
Cape Coral, Florida, United States
The Eye Clinic of Texas, an affiliate of Houston Eye Associates
🇺🇸
League City, Texas, United States
Mercy Medical Research Institute
🇺🇸
Springfield, Missouri, United States
University Hospitals of Cleveland
🇺🇸
Cleveland, Ohio, United States
The Eye Centers of Racine and Kenosha
🇺🇸
Racine, Wisconsin, United States
Sarasota Retina Institute
🇺🇸
Sarasota, Florida, 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
Specialty Eye Care
🇺🇸
Parker, Colorado, United States
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
Martel Eye Medical Group
🇺🇸
Rancho Cordova, California, United States
Cornerstone Eye Care, LLC
🇺🇸
High Point, North Carolina, United States
Carolina Macula and Retina
🇺🇸
Mount Pleasant, South Carolina, United States
Nashville Vision Associates, LLC
🇺🇸
Nashville, Tennessee, United States
Houston Eye Associates
🇺🇸
Kingwood, Texas, United States
Comprehensive Eye Care
🇺🇸
Washington, Missouri, United States
DCT- Shah Research, LLC dba Discovery Clinical Trials
🇺🇸
Mission, Texas, United States