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: NCT02965846
• Other study ID #: 195263-010
• Status: Terminated
• Phase: Phase 3
• Start date: December 13, 2016
• Est. completion date: June 13, 2017

Study information

• Verified date: November 2018
• 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: 43
• Est. completion date: June 13, 2017
• Est. primary completion date: June 13, 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, 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

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
Czechia	Fakultni nemocnice Ostrava	Ostrava
Czechia	Ocni klinika OFTEX	Pardubice
Czechia	FN Kralovske Vinohrady, Ocni Klinika	Praha 10
Czechia	Ocní ambulance	Velká Bíteš
France	CHU de Bordeaux, Service d'Ophtalmologie	Bordeaux
France	CHU Hopital Morvan (Bat 4) Service Daviel Ophtalmologie	Brest Cedex
France	CHU Limoges - Hôpital Dupuytren	Limoges Cedex
Germany	Augenklinik Universitatsklinikum	Dusseldorf
Germany	University Eye Hospital	Freiburg
Germany	University Hospital of Cologne, Dept of Ophthalmology	Koln
Germany	Gutenberg University Medical School, Dept of Ophthalmology	Mainz
Germany	Ludwig-Maximilians-University, Dept of Ophthalmology	Munich
Germany	St. Franziskus Hospital Augenabteilung	Munster
Hungary	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
Italy	Rapallo Hospital, Opthalmology Department	Genova
Italy	Istituto di Oftalmologia	Messina
Italy	Istituto Di Ricovero E Cura A Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)	Milano
Italy	Ospedale San Giuseppe, Universita di Milano	Milano
Italy	University of Pisa, Neurosciences - Section of Ophthalmology	Pisa
Philippines	Asian Eye Institute	Makati City
Philippines	Peregrine Eye and Laser Institute	Makati City
Philippines	The Medical City	Pasig City
Poland	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
Spain	Clinico de Barcelona Casa de la Maternidad	Barcelona
Spain	Institto de Microcirugia Ocular C/Josep Maria Llado	Barcelona
Spain	Clinica Oftalmologica	Huelva
Spain	Instituto Oftalmologico Fernandez-Vega	Oviedo, Principado De Asturias
Spain	Cartuja Vision	Sevilla
Spain	University of Valladolid, Facultad Medicina	Valladolid
Taiwan	Buddhist Tzu Chi General Hospital	Hualien
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei
Turkey	Ege Üniv. Tip Fakültesi	Izmir
Turkey	Erciyes Üniversitesi Tip Fakültesi	Kayseri
United Kingdom	Newcastle University School of Medicine, Dept of Ophthamology	Newcastle-upon-Tyne
United States	Sall Research Medical Center	Artesia	California
United States	Lifelong Vision Foundation	Chesterfield	Missouri
United States	Scott and Christie Associates	Cranberry Township	Pennsylvania
United States	Lugene Eye Institute	Glendale	California
United States	Piedmont Eye Center	Lynchburg	Virginia
United States	Wills Eye Hospital	Philadelphia	Pennsylvania
United States	Devers Eye Institute	Portland	Oregon
United States	Medical Center Ophthalmology Associates	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Czechia,  France,  Germany,  Hungary,  Italy,  Philippines,  Poland,  Spain,  Taiwan,  Turkey,  United Kingdom, 

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 the analysis.	Baseline (day 1) to 6 month visit