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

NCT02965846 | Terminated Phase 3 Results

• 1 other identifier: 195263-010
• Study Type: interventional
• Target: 43
• Locations: 12 countries
• Sites: 49

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

Conditions

Dry Eye Syndromes

Keywords

EDE; evaporative dry eye

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change From Baseline in Tearfilm Break Up Time (TBUT)

  Baseline (day 1) to 6 month visit

Study Arms (2)

AGN-195263

EXPERIMENTAL

Drug: AGN-195263

Vehicle

PLACEBO COMPARATOR

Drug: Vehicle

Interventions

AGN-195263 DRUG

1 drop of AGN-195263 will be instilled in each eye twice daily.

AGN-195263

Vehicle DRUG

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

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (49)

Sall Research Medical Center

Artesia, California, 90701, United States

Location

Lugene Eye Institute

Glendale, California, 91204, United States

Location

Lifelong Vision Foundation

Chesterfield, Missouri, 63017, United States

Location

Devers Eye Institute

Portland, Oregon, 97210, United States

Location

Scott and Christie Associates

Cranberry Township, Pennsylvania, 16066, United States

Location

Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Medical Center Ophthalmology Associates

San Antonio, Texas, 78240, United States

Location

Piedmont Eye Center

Lynchburg, Virginia, 24502, United States

Location

Fakultni nemocnice Ostrava

Ostrava, 708 52, Czechia

Location

Ocni klinika OFTEX

Pardubice, 530 02, Czechia

Location

FN Kralovske Vinohrady, Ocni Klinika

Prague, 100 34, Czechia

Location

Oční ambulance

Velká Bíteš, 595 01, Czechia

Location

CHU de Bordeaux, Service d'Ophtalmologie

Bordeaux, 33076, France

Location

CHU Hopital Morvan (Bat 4) Service Daviel Ophtalmologie

Brest, 29609, France

Location

CHU Limoges - Hôpital Dupuytren

Limoges, 87042, France

Location

University Hospital of Cologne, Dept of Ophthalmology

Cologne, 50937, Germany

Location

Augenklinik Universitatsklinikum

Düsseldorf, 40225, Germany

Location

University Eye Hospital

Freiburg im Breisgau, 79106, Germany

Location

Gutenberg University Medical School, Dept of Ophthalmology

Mainz, 55131, Germany

Location

Ludwig-Maximilians-University, Dept of Ophthalmology

Munich, 80366, Germany

Location

St. Franziskus Hospital Augenabteilung

Münster, 48145, Germany

Location

Dept. of Ophthalmology Semmelweis University

Budapest, H-1085, Hungary

Location

University of Debrecen, Dept of Opthalmology, (DE OEC Szemklinika)

Debrecen, H-4032, Hungary

Location

University of Szeged Szent-Györgyi Albert Clinical Center, Faculty of Medicine, Dept of Ophthalmology

Szeged, H-6720, Hungary

Location

Rapallo Hospital, Opthalmology Department

Genova, 16035, Italy

Location

Istituto di Oftalmologia

Messina, 98122, Italy

Location

Ospedale San Giuseppe, Universita di Milano

Milan, 20123, Italy

Location

Istituto Di Ricovero E Cura A Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)

Milan, 20132, Italy

Location

University of Pisa, Neurosciences - Section of Ophthalmology

Pisa, 56126, Italy

Location

Asian Eye Institute

Makati City, 1200, Philippines

Location

Peregrine Eye and Laser Institute

Makati City, 1209, Philippines

Location

The Medical City

Pasig, 1605, Philippines

Location

Prywatna Klinika Okulistyczna OFTALMIKA

Bydgoszcz, 85-631, Poland

Location

Szpital Specjalistyczny nr 1 w Bytomiu

Bytom, 41-902, Poland

Location

Optimum Profesorskie Centrum Okulistyki

Gdansk, 80-809, Poland

Location

Specjalistyczna Praktyka Lekarska prof. Edward Wylegala

Katowice, 43-300, Poland

Location

Uniwersyteck Szpital Kliniczny im. Jana Mikulicza-Radeckiego

Wroclaw, 50-556, Poland

Location

Institto de Microcirugia Ocular C/Josep Maria Llado

Barcelona, 08035, Spain

Location

Clinico de Barcelona Casa de la Maternidad

Barcelona, 8028, Spain

Location

Clinica Oftalmologica

Huelva, 21004, Spain

Location

Instituto Oftalmologico Fernandez-Vega

Oviedo, Principado de Asturias, 33012, Spain

Location

Cartuja Vision

Seville, 41003, Spain

Location

University of Valladolid, Facultad Medicina

Valladolid, 47005, Spain

Location

Buddhist Tzu Chi General Hospital

Hualien City, 970, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Tri-Service General Hospital

Taipei, 11447, Taiwan

Location

Ege Üniv. Tıp Fakültesi

Izmir, 35040, Turkey (Türkiye)

Location

Erciyes Üniversitesi Tıp Fakültesi

Kayseri, 38039, Turkey (Türkiye)

Location

Newcastle University School of Medicine, Dept of Ophthamology

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Limitations and Caveats

Due to study termination, the study was underpowered

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Allergan, Inc.

clinicaltrials@allergan.com

877-277-8566

Study Officials

• Khristopher Hansen

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2016
• First Posted: November 17, 2016
• Study Start: December 13, 2016
• Primary Completion: June 13, 2017
• Study Completion: June 13, 2017
• Last Updated: November 30, 2018
• Results First Posted: November 30, 2018

Record last verified: 2018-11

Locations

IT (5); PH (3); GB (1); TW (3); PL (5); DE (6); ES (6); HU (3); TU (2); FR (3); US (8); CZ (4)