Clinical trial NCT02965846: Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye
Official title: Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Dry Eye Syndromes
Keywords: EDE
evaporative dry eye
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2016-11-17
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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, 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 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

Primary outcomes:
measure: Overall Ocular Discomfort Score (0 to 4 Scale; 0=None, 4=Very Severe)
timeFrame: 6 month visit
Secondary outcomes:
measure: Change From Baseline in Tearfilm Break Up Time (TBUT)
timeFrame: Baseline (day 1) to 6 month visit
Other outcomes:
Locations:
city: Artesia
country: United States
facility: Sall Research Medical Center
state: California
city: Glendale
country: United States
facility: Lugene Eye Institute
state: California
city: Chesterfield
country: United States
facility: Lifelong Vision Foundation
state: Missouri
city: Portland
country: United States
facility: Devers Eye Institute
state: Oregon
city: Cranberry Township
country: United States
facility: Scott and Christie Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: Wills Eye Hospital
state: Pennsylvania
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates
state: Texas
city: Lynchburg
country: United States
facility: Piedmont Eye Center
state: Virginia
city: Ostrava
country: Czechia
facility: Fakultni nemocnice Ostrava
city: Pardubice
country: Czechia
facility: Ocni klinika OFTEX
city: Praha 10
country: Czechia
facility: FN Kralovske Vinohrady, Ocni Klinika
city: Velká Bíteš
country: Czechia
facility: Oční ambulance
city: Bordeaux
country: France
facility: CHU de Bordeaux, Service d'Ophtalmologie
city: Brest Cedex
country: France
facility: CHU Hopital Morvan (Bat 4) Service Daviel Ophtalmologie
city: Limoges Cedex
country: France
facility: CHU Limoges - Hôpital Dupuytren
city: Dusseldorf
country: Germany
facility: Augenklinik Universitatsklinikum
city: Freiburg
country: Germany
facility: University Eye Hospital
city: Koln
country: Germany
facility: University Hospital of Cologne, Dept of Ophthalmology
city: Mainz
country: Germany
facility: Gutenberg University Medical School, Dept of Ophthalmology
city: Munich
country: Germany
facility: Ludwig-Maximilians-University, Dept of Ophthalmology
city: Munster
country: Germany
facility: St. Franziskus Hospital Augenabteilung
city: Budapest
country: Hungary
facility: Dept. of Ophthalmology Semmelweis University
city: Debrecen
country: Hungary
facility: University of Debrecen, Dept of Opthalmology, (DE OEC Szemklinika)
city: Szeged
country: Hungary
facility: University of Szeged Szent-Györgyi Albert Clinical Center, Faculty of Medicine, Dept of Ophthalmology
city: Genova
country: Italy
facility: Rapallo Hospital, Opthalmology Department
city: Messina
country: Italy
facility: Istituto di Oftalmologia
city: Milano
country: Italy
facility: Ospedale San Giuseppe, Universita di Milano
city: Milano
country: Italy
facility: Istituto Di Ricovero E Cura A Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)
city: Pisa
country: Italy
facility: University of Pisa, Neurosciences - Section of Ophthalmology
city: Makati City
country: Philippines
facility: Asian Eye Institute
city: Makati City
country: Philippines
facility: Peregrine Eye and Laser Institute
city: Pasig City
country: Philippines
facility: The Medical City
city: Bydgoszcz
country: Poland
facility: Prywatna Klinika Okulistyczna OFTALMIKA
city: Bytom
country: Poland
facility: Szpital Specjalistyczny nr 1 w Bytomiu
city: Gdansk
country: Poland
facility: Optimum Profesorskie Centrum Okulistyki
city: Katowice
country: Poland
facility: Specjalistyczna Praktyka Lekarska prof. Edward Wylegala
city: Wroclaw
country: Poland
facility: Uniwersyteck Szpital Kliniczny im. Jana Mikulicza-Radeckiego
city: Barcelona
country: Spain
facility: Institto de Microcirugia Ocular C/Josep Maria Llado
city: Barcelona
country: Spain
facility: Clinico de Barcelona Casa de la Maternidad
city: Huelva
country: Spain
facility: Clinica Oftalmologica
city: Oviedo, Principado De Asturias
country: Spain
facility: Instituto Oftalmologico Fernandez-Vega
city: Sevilla
country: Spain
facility: Cartuja Vision
city: Valladolid
country: Spain
facility: University of Valladolid, Facultad Medicina
city: Hualien
country: Taiwan
facility: Buddhist Tzu Chi General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Izmir
country: Turkey
facility: Ege Üniv. Tıp Fakültesi
city: Kayseri
country: Turkey
facility: Erciyes Üniversitesi Tıp Fakültesi
city: Newcastle-upon-Tyne
country: United Kingdom
facility: Newcastle University School of Medicine, Dept of Ophthamology
Study officials:
affiliation: Allergan
name: Khristopher Hansen
role: STUDY_DIRECTOR
References: