Clinical trial NCT02284516: A Study to Evaluate Efficacy and Safety of Lifitegrast in Subjects With Dry Eye (OPUS-3)
Official title: A Phase 3, Multicenter, Randomized, Double-masked, and Placebo-controlled Study Evaluating the Efficacy and Safety of a 5.0% Concentration of Lifitegrast Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease and History of Recent Artificial Tear Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Disease
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2014-11-06
Enrollment: 711
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: Evaluate the efficacy and safety of Lifitegrast in subjects with dry eye disease and a recent history of artificial tear use.


Eligibility criteria: Inclusion Criteria:

* Patient-reported history of Dry Eye Disease in both eyes.
* Use of over the counter artificial tears within the past 30 days.
* A negative urine pregnancy test for females and willingness to use adequate birth control throughout the study.
* Able and willing to comply with all study procedures.

Exclusion Criteria:

* Presence of an ocular condition that could affect the study parameters such as active ocular infections, ocular inflammation, glaucoma, or diabetic retinopathy;.
* Unwilling to stop wearing contact lenses during the study.
* LASIK or other ocular surgical procedures within 12 months prior to or during the study.
* Use of prohibited medications
* Significant medical conditions that could affect the study parameters.

Primary outcomes:
measure: Change From Baseline in Patient-Reported Eye Dryness Score to Day 84
timeFrame: Baseline to Day 84
Secondary outcomes:
measure: Change From Baseline in Patient-Reported Eye Dryness Score to Day 14 and Day 42
timeFrame: Baseline to Day 14 and Day 42
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham, UAB School of Optometry
state: Alabama
city: Chandler
country: United States
facility: Arizona Eye Center
state: Arizona
city: Artesia
country: United States
facility: Sall Research Medical Center
state: California
city: Inglewood
country: United States
facility: United Medical Research Institute
state: California
city: Mission Hills
country: United States
facility: North Valley Eye Medical Group, Inc
state: California
city: Montebello
country: United States
facility: Montebello Medical Eye Center, Inc.
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Poway
country: United States
facility: Arch Health Partners
state: California
city: Rancho Cordova
country: United States
facility: Martel Eye Medical Group
state: California
city: Redding
country: United States
facility: Shasta Eye Medical Group, Inc.
state: California
city: San Diego
country: United States
facility: West Coast Eye Care Associates
state: California
city: Hoffman Estates
country: United States
facility: Chicago Cornea Consultants, Ltd.
state: Illinois
city: Lake Villa
country: United States
facility: Jackson Eye, SC
state: Illinois
city: Indianapolis
country: United States
facility: Price Vision Group
state: Indiana
city: New Albany
country: United States
facility: John-Kenyon American Eye Institute
state: Indiana
city: Lexington
country: United States
facility: Koffler Vision Group
state: Kentucky
city: Louisville
country: United States
facility: The Eye Care Institute
state: Kentucky
city: Union
country: United States
facility: Holpro Vision, Ltd.
state: Kentucky
city: Winchester
country: United States
facility: Clinical Eye Research of Boston
state: Massachusetts
city: Chesterfield
country: United States
facility: Lifelong Vision Foundation
state: Missouri
city: Kansas City
country: United States
facility: Tauber Eye Center
state: Missouri
city: Saint Louis
country: United States
facility: Tekwani Vision Center
state: Missouri
city: Saint Louis
country: United States
facility: Ophthalmology Consultants, Ltd.
state: Missouri
city: Washington
country: United States
facility: Comprehensive Eye Care, Ltd.
state: Missouri
city: Las Vegas
country: United States
facility: Wellish Vision Institute
state: Nevada
city: Las Vegas
country: United States
facility: Abrams Eye Institute
state: Nevada
city: New York
country: United States
facility: Clinical Vision Research Center at SUNY
state: New York
city: Rockville Centre
country: United States
facility: Ophthalmic Consultants Of Long Island
state: New York
city: Wantagh
country: United States
facility: South Shore Eye Care, LLP
state: New York
city: Cleveland
country: United States
facility: Abrams Eye Center
state: Ohio
city: Cranberry Township
country: United States
facility: Scott & Christie and Associates, PC
state: Pennsylvania
city: Doylestown
country: United States
facility: Matossian Eye Associates
state: Pennsylvania
city: Nashville
country: United States
facility: Toyos Clinic
state: Tennessee
city: El Paso
country: United States
facility: The Cataract & Glaucoma Center
state: Texas
city: Houston
country: United States
facility: Advanced Laser Vision and Surgical Institute
state: Texas
city: Houston
country: United States
facility: Whitsett Vision Group
state: Texas
city: Houston
country: United States
facility: University of Houston College of Optometry
state: Texas
city: League City
country: United States
facility: The Eye Clinic of Texas (Houston Eye Associates)
state: Texas
city: San Antonio
country: United States
facility: Eye Clinics of South Texas, P.A.
state: Texas
city: San Antonio
country: United States
facility: R and R Eye Research, LLC.
state: Texas
city: McLean
country: United States
facility: See Clearly Vision
state: Virginia
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Holland EJ, Jackson MA, Donnenfeld E, Piccolo R, Cohen A, Barabino S, Rolando M, Figueiredo FC. Efficacy of Lifitegrast Ophthalmic Solution, 5.0%, in Patients With Moderate to Severe Dry Eye Disease: A Post Hoc Analysis of 2 Randomized Clinical Trials. JAMA Ophthalmol. 2021 Nov 1;139(11):1200-1208. doi: 10.1001/jamaophthalmol.2021.3943.
citation: Holland EJ, Luchs J, Karpecki PM, Nichols KK, Jackson MA, Sall K, Tauber J, Roy M, Raychaudhuri A, Shojaei A. Lifitegrast for the Treatment of Dry Eye Disease: Results of a Phase III, Randomized, Double-Masked, Placebo-Controlled Trial (OPUS-3). Ophthalmology. 2017 Jan;124(1):53-60. doi: 10.1016/j.ophtha.2016.09.025. Epub 2016 Oct 27.