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

Phase 3

Terminated

Conditions: Dry Eye Syndromes

Interventions: Drug: AGN-195263
Drug: Vehicle

Registration Number: NCT02965846

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: 43

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, 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

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 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
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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

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

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 the analysis.

Trial Locations

Locations (49): Sall Research Medical Center
🇺🇸
Artesia, California, United States
Lugene Eye Institute
🇺🇸
Glendale, California, United States
Lifelong Vision Foundation
🇺🇸
Chesterfield, Missouri, United States
Devers Eye Institute
🇺🇸
Portland, Oregon, United States
Scott and Christie Associates
🇺🇸
Cranberry Township, Pennsylvania, United States
Wills Eye Hospital
🇺🇸
Philadelphia, Pennsylvania, United States
Medical Center Ophthalmology Associates
🇺🇸
San Antonio, Texas, United States
Piedmont Eye Center
🇺🇸
Lynchburg, Virginia, United States
Fakultni nemocnice Ostrava
🇨🇿
Ostrava, Czechia
Ocni klinika OFTEX
🇨🇿
Pardubice, Czechia
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Sall Research Medical Center
🇺🇸Artesia, California, United States