--- title: Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye nct_id: NCT02815293 overall_status: TERMINATED phase: PHASE3 sponsor: Allergan study_type: INTERVENTIONAL primary_condition: Dry Eye Syndromes countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02815293.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02815293" ct_last_update_post_date: 2019-02-19 last_seen_at: "2026-05-12T07:26:32.985Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye **NCT ID:** [NCT02815293](https://clinicaltrials.gov/study/NCT02815293) ## Key Facts - **Status:** TERMINATED - **Phase:** PHASE3 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 36 - **Lead Sponsor:** Allergan - **Conditions:** Dry Eye Syndromes - **Start Date:** 2016-09-30 - **Completion Date:** 2017-06-21 - **CT.gov Last Update:** 2019-02-19 ## 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 ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **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 - **AGN-195263** (EXPERIMENTAL) - **Vehicle** (PLACEBO_COMPARATOR) ## Interventions - **AGN-195263** (DRUG) — 1 drop of AGN-195263 will be instilled in each eye twice daily. - **Vehicle** (DRUG) — 1 drop of AGN-195263 vehicle (placebo) will be instilled in each eye twice daily. ## 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)** _(time frame: Baseline (day 1) to 6 month visit)_ ## Locations (29) - 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 - Eye Research Foundation, Newport Beach, California, United States - North Bay Eye Associates, Petaluma, California, United States - Martel Eye Medical Group, Rancho Cordova, California, United States - Centennial Eye and Cosmetic Associates, Centennial, Colorado, United States - Specialty Eye Care, Parker, Colorado, United States - Argus Research at Cape Coral Eye Center, Cape Coral, Florida, United States - Sarasota Retina Institute, Sarasota, Florida, United States - Eye Care Centers Management, Inc. dba Clayton Eye Center, Morrow, Georgia, United States - Taustine Eye Center, Louisville, Kentucky, United States - Eye Doctors of Washington, Chevy Chase, Maryland, United States - Mercy Medical Research Institute, Springfield, Missouri, United States - Ophthalmology Consultants, Ltd, St Louis, Missouri, United States - Comprehensive Eye Care, Washington, Missouri, United States - Cornerstone Eye Care, LLC, High Point, North Carolina, United States - University Hospitals of Cleveland, Cleveland, Ohio, United States - Carolina Macula and Retina, Mt. Pleasant, South Carolina, United States - Nashville Vision Associates, LLC, Nashville, Tennessee, United States - Robert Cizik Eye Clinic, Houston, Texas, United States - Houston Eye Associates, Kingwood, Texas, United States - Brazosport Eye Institute, Lake Jackson, Texas, United States - The Eye Clinic of Texas, an affiliate of Houston Eye Associates, League City, Texas, United States - DCT- Shah Research, LLC dba Discovery Clinical Trials, Mission, Texas, 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 - The Eye Centers of Racine and Kenosha, Racine, Wisconsin, United States ## Recent Field Changes (last 30 days) - `locations.specialty eye care|parker|colorado|united states` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `locations.argus research at cape coral eye center|cape coral|florida|united states` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.arizona eye center|chandler|arizona|united states` — added _(2026-05-12)_ - `locations.clearsight|fullerton|california|united states` — added _(2026-05-12)_ - `locations.orange county ophthalmology medical group|garden grove|california|united states` — added _(2026-05-12)_ - `locations.montebello medical center, inc.|montebello|california|united states` — added _(2026-05-12)_ - `locations.eye research foundation|newport beach|california|united states` — added _(2026-05-12)_ - `locations.north bay eye associates|petaluma|california|united states` — added _(2026-05-12)_ - `locations.martel eye medical group|rancho cordova|california|united states` — added _(2026-05-12)_ - `locations.centennial eye and cosmetic associates|centennial|colorado|united states` — added _(2026-05-12)_ - `locations.sarasota retina institute|sarasota|florida|united states` — added _(2026-05-12)_ - `locations.eye care centers management, inc. dba clayton eye center|morrow|georgia|united states` — added _(2026-05-12)_ - `locations.taustine eye center|louisville|kentucky|united states` — added _(2026-05-12)_ - `locations.eye doctors of washington|chevy chase|maryland|united states` — added _(2026-05-12)_ - `locations.mercy medical research institute|springfield|missouri|united states` — added _(2026-05-12)_ - `locations.ophthalmology consultants, ltd|st louis|missouri|united states` — added _(2026-05-12)_ - `locations.comprehensive eye care|washington|missouri|united states` — added _(2026-05-12)_ - `locations.cornerstone eye care, llc|high point|north carolina|united states` — added _(2026-05-12)_ - `locations.university hospitals of cleveland|cleveland|ohio|united states` — added _(2026-05-12)_ - `locations.carolina macula and retina|mt. pleasant|south carolina|united states` — added _(2026-05-12)_ - `locations.nashville vision associates, llc|nashville|tennessee|united states` — added _(2026-05-12)_ - `locations.robert cizik eye clinic|houston|texas|united states` — added _(2026-05-12)_ - `locations.houston eye associates|kingwood|texas|united states` — added _(2026-05-12)_ - `locations.brazosport eye institute|lake jackson|texas|united states` — added _(2026-05-12)_ - `locations.the eye clinic of texas, an affiliate of houston eye associates|league city|texas|united states` — added _(2026-05-12)_ - `locations.dct- shah research, llc dba discovery clinical trials|mission|texas|united states` — added _(2026-05-12)_ - `locations.r and r eye research, llc|san antonio|texas|united states` — added _(2026-05-12)_ - `locations.stacy r. smith, m.d., p.c.|salt lake city|utah|united states` — added _(2026-05-12)_ - `locations.the eye centers of racine and kenosha|racine|wisconsin|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT02815293.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT02815293* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*