Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye
NCT ID: NCT02965846
Last Updated: 2018-11-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
43 participants
INTERVENTIONAL
2016-12-13
2017-06-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AGN-195263
AGN-195263
1 drop of AGN-195263 will be instilled in each eye twice daily.
Vehicle
Vehicle
1 drop of AGN-195263 vehicle(placebo) will be instilled in each eye twice daily.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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, 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Allergan
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Khristopher Hansen
Role: STUDY_DIRECTOR
Allergan
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sall Research Medical Center
Artesia, California, United States
Lugene Eye Institute
Glendale, California, United States
Lifelong Vision Foundation
Chesterfield, Missouri, United States
Devers Eye Institute
Portland, Oregon, United States
Scott and Christie Associates
Cranberry Township, Pennsylvania, United States
Wills Eye Hospital
Philadelphia, Pennsylvania, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, United States
Piedmont Eye Center
Lynchburg, Virginia, United States
Fakultni nemocnice Ostrava
Ostrava, , Czechia
Ocni klinika OFTEX
Pardubice, , Czechia
FN Kralovske Vinohrady, Ocni Klinika
Prague, , Czechia
Oční ambulance
Velká Bíteš, , Czechia
CHU de Bordeaux, Service d'Ophtalmologie
Bordeaux, , France
CHU Hopital Morvan (Bat 4) Service Daviel Ophtalmologie
Brest, , France
CHU Limoges - Hôpital Dupuytren
Limoges, , France
University Hospital of Cologne, Dept of Ophthalmology
Cologne, , Germany
Augenklinik Universitatsklinikum
Düsseldorf, , Germany
University Eye Hospital
Freiburg im Breisgau, , Germany
Gutenberg University Medical School, Dept of Ophthalmology
Mainz, , Germany
Ludwig-Maximilians-University, Dept of Ophthalmology
Munich, , Germany
St. Franziskus Hospital Augenabteilung
Münster, , Germany
Dept. of Ophthalmology Semmelweis University
Budapest, , Hungary
University of Debrecen, Dept of Opthalmology, (DE OEC Szemklinika)
Debrecen, , Hungary
University of Szeged Szent-Györgyi Albert Clinical Center, Faculty of Medicine, Dept of Ophthalmology
Szeged, , Hungary
Rapallo Hospital, Opthalmology Department
Genova, , Italy
Istituto di Oftalmologia
Messina, , Italy
Ospedale San Giuseppe, Universita di Milano
Milan, , Italy
Istituto Di Ricovero E Cura A Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)
Milan, , Italy
University of Pisa, Neurosciences - Section of Ophthalmology
Pisa, , Italy
Asian Eye Institute
Makati City, , Philippines
Peregrine Eye and Laser Institute
Makati City, , Philippines
The Medical City
Pasig, , Philippines
Prywatna Klinika Okulistyczna OFTALMIKA
Bydgoszcz, , Poland
Szpital Specjalistyczny nr 1 w Bytomiu
Bytom, , Poland
Optimum Profesorskie Centrum Okulistyki
Gdansk, , Poland
Specjalistyczna Praktyka Lekarska prof. Edward Wylegala
Katowice, , Poland
Uniwersyteck Szpital Kliniczny im. Jana Mikulicza-Radeckiego
Wroclaw, , Poland
Institto de Microcirugia Ocular C/Josep Maria Llado
Barcelona, , Spain
Clinico de Barcelona Casa de la Maternidad
Barcelona, , Spain
Clinica Oftalmologica
Huelva, , Spain
Instituto Oftalmologico Fernandez-Vega
Oviedo, Principado de Asturias, , Spain
Cartuja Vision
Seville, , Spain
University of Valladolid, Facultad Medicina
Valladolid, , Spain
Buddhist Tzu Chi General Hospital
Hualien City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Tri-Service General Hospital
Taipei, , Taiwan
Ege Üniv. Tıp Fakültesi
Izmir, , Turkey (Türkiye)
Erciyes Üniversitesi Tıp Fakültesi
Kayseri, , Turkey (Türkiye)
Newcastle University School of Medicine, Dept of Ophthamology
Newcastle upon Tyne, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
195263-010
Identifier Type: -
Identifier Source: org_study_id