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

Dry Eye Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02815293
• Other study ID #: 195263-009
• Status: Terminated
• Phase: Phase 3
• Start date: September 30, 2016
• Est. completion date: June 21, 2017

Study information

• Verified date: February 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: June 21, 2017
• Est. primary completion date: June 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

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

Locations

Country	Name	City	State
United States	Argus Research at Cape Coral Eye Center	Cape Coral	Florida
United States	Centennial Eye and Cosmetic Associates	Centennial	Colorado
United States	Arizona Eye Center	Chandler	Arizona
United States	Eye Doctors of Washington	Chevy Chase	Maryland
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	Clearsight	Fullerton	California
United States	Orange County Ophthalmology Medical Group	Garden Grove	California
United States	Cornerstone Eye Care, LLC	High Point	North Carolina
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	Taustine Eye Center	Louisville	Kentucky
United States	DCT- Shah Research, LLC dba Discovery Clinical Trials	Mission	Texas
United States	Montebello Medical Center, Inc.	Montebello	California
United States	Eye Care Centers Management, Inc. dba Clayton Eye Center	Morrow	Georgia
United States	Carolina Macula and Retina	Mount Pleasant	South Carolina
United States	Nashville Vision Associates, LLC	Nashville	Tennessee
United States	Eye Research Foundation	Newport Beach	California
United States	Specialty Eye Care	Parker	Colorado
United States	North Bay Eye Associates	Petaluma	California
United States	The Eye Centers of Racine and Kenosha	Racine	Wisconsin
United States	Martel Eye Medical Group	Rancho Cordova	California
United States	Ophthalmology Consultants, Ltd	Saint Louis	Missouri
United States	Stacy R. Smith, M.D., P.C.	Salt Lake City	Utah
United States	R and R Eye Research, LLC	San Antonio	Texas
United States	Sarasota Retina Institute	Sarasota	Florida
United States	Mercy Medical Research Institute	Springfield	Missouri
United States	Comprehensive Eye Care	Washington	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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