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

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 Overview

• Status: Terminated
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Drug: AGN-195263; Drug: Vehicle

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85225
      • Arizona Eye Center
  • California
    • Fullerton, California, United States, 92835
      • Clearsight
    • Garden Grove, California, United States, 92843
      • Orange County Ophthalmology Medical Group
    • Montebello, California, United States, 90640
      • Montebello Medical Center, Inc.
    • Newport Beach, California, United States, 92663
      • Eye Research Foundation
    • Petaluma, California, United States, 94954
      • North Bay Eye Associates
    • Rancho Cordova, California, United States, 95670
      • Martel Eye Medical Group
  • Colorado
    • Centennial, Colorado, United States, 80016
      • Centennial Eye and Cosmetic Associates
    • Parker, Colorado, United States, 80134
      • Specialty Eye Care
  • Florida
    • Cape Coral, Florida, United States, 33904
      • Argus Research at Cape Coral Eye Center
    • Sarasota, Florida, United States, 34239
      • Sarasota Retina Institute
  • Georgia
    • Morrow, Georgia, United States, 30260
      • Eye Care Centers Management, Inc. dba Clayton Eye Center
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Taustine Eye Center
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Eye Doctors of Washington
  • Missouri
    • Saint Louis, Missouri, United States, 63131
      • Ophthalmology Consultants, Ltd
    • Springfield, Missouri, United States, 65804
      • Mercy Medical Research Institute
    • Washington, Missouri, United States, 63090
      • Comprehensive Eye Care
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Cornerstone Eye Care, LLC
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Of Cleveland
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • Carolina Macula and Retina
  • Tennessee
    • Nashville, Tennessee, United States, 37205
      • Nashville Vision Associates, LLC
  • Texas
    • Houston, Texas, United States, 77030
      • Robert Cizik Eye Clinic
    • Kingwood, Texas, United States, 77339
      • Houston Eye Associates
    • Lake Jackson, Texas, United States, 77566
      • Brazosport Eye Institute
    • League City, Texas, United States, 77573
      • The Eye Clinic of Texas, an affiliate of Houston Eye Associates
    • Mission, Texas, United States, 78572
      • DCT- Shah Research, LLC dba Discovery Clinical Trials
    • San Antonio, Texas, United States, 78229
      • R and R Eye Research, LLC
  • Utah
    • Salt Lake City, Utah, United States, 84117
      • Stacy R. Smith, M.D., P.C.
  • Wisconsin
    • Racine, Wisconsin, United States, 53405
      • The Eye Centers of Racine and Kenosha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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 analysis	Baseline (day 1) to 6 month visit

Collaborators and Investigators

• Sponsor: Allergan

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2016
• Primary Completion (Actual): June 21, 2017
• Study Completion (Actual): June 21, 2017

Study Registration Dates

• First Submitted: June 24, 2016
• First Submitted That Met QC Criteria: June 24, 2016
• First Posted (Estimate): June 28, 2016

Study Record Updates

• Last Update Posted (Actual): February 19, 2019
• Last Update Submitted That Met QC Criteria: February 15, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: EDE; evaporative dry eye
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: 195263-009