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

Allergan29 sites in 1 country36 target enrollmentSeptember 30, 2016

ConditionsDry Eye Syndromes

InterventionsAGN-195263 Vehicle

DrugsAGN-195263 Vehicle

Overview

Phase: Phase 3
Intervention: AGN-195263
Conditions: Dry Eye Syndromes
Sponsor: Allergan
Enrollment: 36
Locations: 29
Primary Endpoint: Overall Ocular Discomfort Score (0 to 4 Scale; 0=None, 4=Very Severe)
Status: Terminated
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

September 30, 2016

End Date

June 21, 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Allergan

Responsible Party

Sponsor

Eligibility Criteria

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)

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

Arms & Interventions

AGN-195263

Intervention: AGN-195263

Vehicle

Intervention: Vehicle

Outcomes

Primary Outcomes

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.