Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye
- Registration Number
- NCT02965846
- Lead Sponsor
- Allergan
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 43
-
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)
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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, lid hygiene (ie, warm compress, lid massage, lid scrub), omega-3 supplementation (topical ocular or systemic), or antibiotics (ie, systemic or topical macrolides, tetracyclines, tetracycline derivatives [including doxycycline and minocycline]) for the treatment of dry eye disease, or meibomian gland disease within 1 year of the standardization (day -21) visit
- 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 using estrogen and/or progesterone containing products (including herbal and nutritional supplements) and not on a stable dose (at least 90 days prior to the standardization visit (day -21) and/or anticipate initiating use and/or changing 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 topical corticosteroids in the eyes or on the eyelids within 60 days prior to the standardization visit (day -21), or any such use anticipated prior to the month 6 visit
- Patients who are currently using or have used oral or topical macrolides, tetracyclines, tetracycline derivative drugs (including doxycycline and minocycline), retinoids (eg, isotretinoin), calcineurin inhibitors (ie, RESTASIS®, Ikervis®), oral (systemic) corticosteroids, or lifitegrast (Xiidra™) or any other therapeutic dry eye treatment within 60 days of the standardization visit (day -21), or anticipated use before the month 6 visit
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AGN-195263 AGN-195263 - Vehicle Vehicle -
- Primary Outcome Measures
Name Time Method Overall Ocular Discomfort Score (0 to 4 Scale; 0=None, 4=Very Severe) 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 Outcome Measures
Name Time Method Change From Baseline in Tearfilm Break Up Time (TBUT) Baseline (day 1) to 6 month visit 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 the analysis.
Trial Locations
- Locations (49)
The Medical City
🇵🇭Pasig City, Philippines
Ospedale San Giuseppe, Universita di Milano
🇮🇹Milano, Italy
Ludwig-Maximilians-University, Dept of Ophthalmology
🇩🇪Munich, Germany
Oční ambulance
🇨🇿Velká Bíteš, Czechia
University Eye Hospital
🇩🇪Freiburg, Germany
Scott and Christie Associates
🇺🇸Cranberry Township, Pennsylvania, United States
St. Franziskus Hospital Augenabteilung
🇩🇪Munster, Germany
FN Kralovske Vinohrady, Ocni Klinika
🇨🇿Praha 10, Czechia
Fakultni nemocnice Ostrava
🇨🇿Ostrava, Czechia
Augenklinik Universitatsklinikum
🇩🇪Dusseldorf, Germany
CHU de Bordeaux, Service d'Ophtalmologie
🇫🇷Bordeaux, France
Piedmont Eye Center
🇺🇸Lynchburg, Virginia, United States
Medical Center Ophthalmology Associates
🇺🇸San Antonio, Texas, United States
Gutenberg University Medical School, Dept of Ophthalmology
🇩🇪Mainz, Germany
Specjalistyczna Praktyka Lekarska prof. Edward Wylegala
🇵🇱Katowice, Poland
Erciyes Üniversitesi Tıp Fakültesi
🇹🇷Kayseri, Turkey
Buddhist Tzu Chi General Hospital
🇨🇳Hualien, Taiwan
University of Valladolid, Facultad Medicina
🇪🇸Valladolid, Spain
Institto de Microcirugia Ocular C/Josep Maria Llado
🇪🇸Barcelona, Spain
Newcastle University School of Medicine, Dept of Ophthamology
🇬🇧Newcastle-upon-Tyne, United Kingdom
Cartuja Vision
🇪🇸Sevilla, Spain
Ege Üniv. Tıp Fakültesi
🇹🇷Izmir, Turkey
Rapallo Hospital, Opthalmology Department
🇮🇹Genova, Italy
University of Pisa, Neurosciences - Section of Ophthalmology
🇮🇹Pisa, Italy
CHU Hopital Morvan (Bat 4) Service Daviel Ophtalmologie
🇫🇷Brest Cedex, France
CHU Limoges - Hôpital Dupuytren
🇫🇷Limoges Cedex, France
Lifelong Vision Foundation
🇺🇸Chesterfield, Missouri, United States
Devers Eye Institute
🇺🇸Portland, Oregon, United States
Lugene Eye Institute
🇺🇸Glendale, California, United States
Sall Research Medical Center
🇺🇸Artesia, California, United States
Wills Eye Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Ocni klinika OFTEX
🇨🇿Pardubice, Czechia
University Hospital of Cologne, Dept of Ophthalmology
🇩🇪Koln, Germany
Istituto Di Ricovero E Cura A Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)
🇮🇹Milano, Italy
Istituto di Oftalmologia
🇮🇹Messina, Italy
Instituto Oftalmologico Fernandez-Vega
🇪🇸Oviedo, Principado De Asturias, Spain
Clinico de Barcelona Casa de la Maternidad
🇪🇸Barcelona, Spain
Clinica Oftalmologica
🇪🇸Huelva, Spain
Asian Eye Institute
🇵🇭Makati City, Philippines
Tri-Service General Hospital
🇨🇳Taipei, Taiwan
University of Szeged Szent-Györgyi Albert Clinical Center, Faculty of Medicine, Dept of Ophthalmology
🇭🇺Szeged, Hungary
Uniwersyteck Szpital Kliniczny im. Jana Mikulicza-Radeckiego
🇵🇱Wroclaw, Poland
University of Debrecen, Dept of Opthalmology, (DE OEC Szemklinika)
🇭🇺Debrecen, Hungary
Peregrine Eye and Laser Institute
🇵🇭Makati City, Philippines
Optimum Profesorskie Centrum Okulistyki
🇵🇱Gdansk, Poland
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Prywatna Klinika Okulistyczna OFTALMIKA
🇵🇱Bydgoszcz, Poland
Szpital Specjalistyczny nr 1 w Bytomiu
🇵🇱Bytom, Poland
Dept. of Ophthalmology Semmelweis University
🇭🇺Budapest, Hungary