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

NCT02815293 | Terminated Phase 3 Results

• 1 other identifier: 195263-009
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 29

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

Conditions

Dry Eye Syndromes

Keywords

EDE; evaporative dry eye

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change From Baseline in Tearfilm Break Up Time (TBUT)

  Baseline (day 1) to 6 month visit

Study Arms (2)

AGN-195263

EXPERIMENTAL

Drug: AGN-195263

Vehicle

PLACEBO COMPARATOR

Drug: Vehicle

Interventions

AGN-195263 DRUG

1 drop of AGN-195263 will be instilled in each eye twice daily.

AGN-195263

Vehicle DRUG

1 drop of AGN-195263 vehicle (placebo) will be instilled in each eye twice daily.

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (29)

Arizona Eye Center

Chandler, Arizona, 85225, United States

Location

Clearsight

Fullerton, California, 92835, United States

Location

Orange County Ophthalmology Medical Group

Garden Grove, California, 92843, United States

Location

Montebello Medical Center, Inc.

Montebello, California, 90640, United States

Location

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

North Bay Eye Associates

Petaluma, California, 94954, United States

Location

Martel Eye Medical Group

Rancho Cordova, California, 95670, United States

Location

Centennial Eye and Cosmetic Associates

Centennial, Colorado, 80016, United States

Location

Specialty Eye Care

Parker, Colorado, 80134, United States

Location

Argus Research at Cape Coral Eye Center

Cape Coral, Florida, 33904, United States

Location

Sarasota Retina Institute

Sarasota, Florida, 34239, United States

Location

Eye Care Centers Management, Inc. dba Clayton Eye Center

Morrow, Georgia, 30260, United States

Location

Taustine Eye Center

Louisville, Kentucky, 40217, United States

Location

Eye Doctors of Washington

Chevy Chase, Maryland, 20815, United States

Location

Mercy Medical Research Institute

Springfield, Missouri, 65804, United States

Location

Ophthalmology Consultants, Ltd

St Louis, Missouri, 63131, United States

Location

Comprehensive Eye Care

Washington, Missouri, 63090, United States

Location

Cornerstone Eye Care, LLC

High Point, North Carolina, 27262, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Carolina Macula and Retina

Mt. Pleasant, South Carolina, 29464, United States

Location

Nashville Vision Associates, LLC

Nashville, Tennessee, 37205, United States

Location

Robert Cizik Eye Clinic

Houston, Texas, 77030, United States

Location

Houston Eye Associates

Kingwood, Texas, 77339, United States

Location

Brazosport Eye Institute

Lake Jackson, Texas, 77566, United States

Location

The Eye Clinic of Texas, an affiliate of Houston Eye Associates

League City, Texas, 77573, United States

Location

DCT- Shah Research, LLC dba Discovery Clinical Trials

Mission, Texas, 78572, United States

Location

R and R Eye Research, LLC

San Antonio, Texas, 78229, United States

Location

Stacy R. Smith, M.D., P.C.

Salt Lake City, Utah, 84117, United States

Location

The Eye Centers of Racine and Kenosha

Racine, Wisconsin, 53405, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Limitations and Caveats

Due to study termination, the study was underpowered

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Allergan, Inc.

clinicaltrials@allergan.com

877-277-8566

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: June 28, 2016
• Study Start: September 30, 2016
• Primary Completion: June 21, 2017
• Study Completion: June 21, 2017
• Last Updated: February 19, 2019
• Results First Posted: February 19, 2019

Record last verified: 2019-02

Locations

US (29)