NCT02815293TerminatedPhase 3
Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Allergan
- Enrollment
- 36
- Locations
- 29
- Primary Endpoint
- Overall Ocular Discomfort Score (0 to 4 Scale; 0=None, 4=Very Severe)
Study 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
AGN-195263
Experimental
Intervention: AGN-195263 (Drug)
Vehicle
Placebo Comparator
Intervention: Vehicle (Drug)
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.
Secondary Outcomes
- Change From Baseline in Tearfilm Break Up Time (TBUT)(Baseline (day 1) to 6 month visit)
Investigators
Study Sites (29)
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