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

Study Overview
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Brief Summary
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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

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

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Drug: AGN-195263
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AGN-195263<br> | Drug: AGN-195263<br>* 1 drop of AGN-195263 will be instilled in each eye twice daily.<br>|
| Placebo Comparator: Vehicle<br> | Drug: Vehicle<br>* 1 drop of AGN-195263 vehicle(placebo) will be instilled in each eye twice daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Ocular Discomfort Score (0 to 4 Scale; 0=None, 4=Very Severe) | 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. | 6 month visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Tearfilm Break Up Time (TBUT) | 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. | Baseline (day 1) to 6 month visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EDE, evaporative dry eye