Clinical trial NCT02815293: Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye
Official title: Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Dry Eye Syndromes
Keywords: EDE
evaporative dry eye
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2016-06-28
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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)
  * 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

Primary outcomes:
measure: Overall Ocular Discomfort Score (0 to 4 Scale; 0=None, 4=Very Severe)
timeFrame: 6 month visit
Secondary outcomes:
measure: Change From Baseline in Tearfilm Break Up Time (TBUT)
timeFrame: Baseline (day 1) to 6 month visit
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Arizona Eye Center
state: Arizona
city: Fullerton
country: United States
facility: Clearsight
state: California
city: Garden Grove
country: United States
facility: Orange County Ophthalmology Medical Group
state: California
city: Montebello
country: United States
facility: Montebello Medical Center, Inc.
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Petaluma
country: United States
facility: North Bay Eye Associates
state: California
city: Rancho Cordova
country: United States
facility: Martel Eye Medical Group
state: California
city: Centennial
country: United States
facility: Centennial Eye and Cosmetic Associates
state: Colorado
city: Parker
country: United States
facility: Specialty Eye Care
state: Colorado
city: Cape Coral
country: United States
facility: Argus Research at Cape Coral Eye Center
state: Florida
city: Sarasota
country: United States
facility: Sarasota Retina Institute
state: Florida
city: Morrow
country: United States
facility: Eye Care Centers Management, Inc. dba Clayton Eye Center
state: Georgia
city: Louisville
country: United States
facility: Taustine Eye Center
state: Kentucky
city: Chevy Chase
country: United States
facility: Eye Doctors of Washington
state: Maryland
city: Saint Louis
country: United States
facility: Ophthalmology Consultants, Ltd
state: Missouri
city: Springfield
country: United States
facility: Mercy Medical Research Institute
state: Missouri
city: Washington
country: United States
facility: Comprehensive Eye Care
state: Missouri
city: High Point
country: United States
facility: Cornerstone Eye Care, LLC
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Mount Pleasant
country: United States
facility: Carolina Macula and Retina
state: South Carolina
city: Nashville
country: United States
facility: Nashville Vision Associates, LLC
state: Tennessee
city: Houston
country: United States
facility: Robert Cizik Eye Clinic
state: Texas
city: Kingwood
country: United States
facility: Houston Eye Associates
state: Texas
city: Lake Jackson
country: United States
facility: Brazosport Eye Institute
state: Texas
city: League City
country: United States
facility: The Eye Clinic of Texas, an affiliate of Houston Eye Associates
state: Texas
city: Mission
country: United States
facility: DCT- Shah Research, LLC dba Discovery Clinical Trials
state: Texas
city: San Antonio
country: United States
facility: R and R Eye Research, LLC
state: Texas
city: Salt Lake City
country: United States
facility: Stacy R. Smith, M.D., P.C.
state: Utah
city: Racine
country: United States
facility: The Eye Centers of Racine and Kenosha
state: Wisconsin
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References: