A Phase 3 Study to Evaluate the Efficacy of Lifitegrast in Subjects With Dry Eye

Dry Eye Disease Clinical Trial

Official title:

A Phase 3, Multicenter, Randomized, Double-Masked and Placebo-Controlled Study Evaluating the Efficacy of a 5.0% Concentration of Lifitegrast Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Currently Using Artificial Tears (OPUS-2)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01743729
• Other study ID #: 1118-DRY-300
• Status: Completed
• Phase: Phase 3
• Start date: December 7, 2012
• Est. completion date: October 1, 2013

Study information

• Verified date: June 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the safety and efficacy of lifitegrast ophthalmic solution compared to placebo in the treatment of dry eye.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 720
• Est. completion date: October 1, 2013
• Est. primary completion date: October 1, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Willing and able to read, sign and date the informed consent and HIPAA documents

• Willing and able to comply with all study procedures

• Be at least 18 years of age

• Patient-reported history of dry eye in both eyes

• A negative urine pregnancy test if female of childbearing potential and must use adequate birth control throughout the study period

• Artificial tear use within the past 30 days

Exclusion Criteria:

• Any ocular condition that, in the opinion of the Investigator, could affect study parameters including, but not limited to, active ocular infection, ocular inflammation, glaucoma, and/or diabetic retinopathy

• Unwilling to avoid wearing contact lenses for 7 days prior to first visit and for the duration of the study

• Any blood donation or significant loss of blood within 56 days of Visit 1

• Any history of immunodeficiency disorder, positive HIV, hepatitis B, C, or evidence of acute active hepatitis A (anti-HAV IgM), or organ or bone marrow transplant.

• Use of any prohibited medications at any time during the study unless otherwise specified

• Any significant illness that could interfere with study parameters

• History of laser assisted in situ keratomileusis (LASIK) or similar type of corneal refractive surgery within 12 months prior to first visit, and/or any other ocular surgical procedure within 12 months prior to first visit; or any scheduled ocular surgical procedure during the study period.

• Known history of alcohol and/or drug abuse

• Subjects with Dry eye secondary to scarring or destruction of conjunctival goblet cells (as with Vitamin A deficiency)

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Lifitegrast
Lifitegrast Ophthalmic Solution 5.0%
• Placebo
Placebo for Lifitegrast Ophthalmic Solution 5.0%

Locations

Country	Name	City	State
United States	OPUS-2 Investigational Site	Artesia	California
United States	OPUS-2 Investigational Site	Chesterfield	Missouri
United States	OPUS-2 Investigational Site	Cleveland	Ohio
United States	OPUS-2 Investigational Site	Danbury	Connecticut
United States	OPUS-2 Investigational Site	Des Peres	Missouri
United States	OPUS-2 Investigational Site	Fort Myers	Florida
United States	OPUS-2 Investigational Site	Hemet	California
United States	OPUS-2 Investigational Site	Hoffman Estates	Illinois
United States	OPUS-2 Investigational Site	Houston	Texas
United States	OPUS-2 Investigational Site	Houston	Texas
United States	OPUS-2 Investigational Site	Independence	Missouri
United States	OPUS-2 Investigational Site	Indianapolis	Indiana
United States	OPUS-2 Investigational Site	Kansas City	Missouri
United States	OPUS-2 Investigational Site	Lancaster	California
United States	OPUS-2 Investigational Site	League City	Texas
United States	OPUS-2 Investigational Site	Lexington	Kentucky
United States	OPUS-2 Investigational Site	Mission Hills	California
United States	OPUS-2 Investigational Site	Montebello	California
United States	OPUS-2 Investigational Site	New Albany	Indiana
United States	OPUS-2 Investigational Site	New York	New York
United States	OPUS-2 Investigational Site	New York	New York
United States	OPUS-2 Investigational Site	Newport Beach	California
United States	OPUS-2 Investigational Site	Norfolk	Virginia
United States	OPUS-2 Investigational Site	Petaluma	California
United States	OPUS-2 Investigational Site	Philadelphia	Pennsylvania
United States	OPUS-2 Investigational SIte	Rancho Cordova	California
United States	OPUS-2 Investigational Site	Saint Paul	Minnesota
United States	OPUS-2 Investigational Site	San Antonio	Texas
United States	OPUS-2 Investigational Site	San Antonio	Texas
United States	OPUS-2 Investigational Site	Wantagh	New York
United States	OPUS-2 Investigational Site	Washington	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

United States, 

References & Publications (1)

Tauber J, Karpecki P, Latkany R, Luchs J, Martel J, Sall K, Raychaudhuri A, Smith V, Semba CP; OPUS-2 Investigators. Lifitegrast Ophthalmic Solution 5.0% versus Placebo for Treatment of Dry Eye Disease: Results of the Randomized Phase III OPUS-2 Study. Op — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Inferior Corneal Fluorescein Staining Score to Day 84	Corneal staining was performed to grade the degree of corneal epithelial cell injury as measured by fluorescence using slit-lamp examination. The corneal surface is divided into three regions: superior, central and inferior. The scores for each of these 3 regions ranged from 0 to 4 (0=no staining; 1=few/rare punctate lesions; 2=discrete and countable lesions; 3=lesions too numerous to count, but not coalescent; 4=coalescent) with 0.5 point increments, and lower scores indicate improvement. Inferior corneal fluorescein staining scores from the study eye only were reported. Study eye is the 'worse eye', defined as the eye with worse (higher) score at baseline.	Baseline to Day 84
Primary	Change From Baseline in Eye Dryness Score (Visual Analogue Scale) to Day 84	Eye dryness score was assessed on a visual analogue scale (a 7-item [burning/stinging, itching, foreign body sensation, eye discomfort, eye dryness, photophobia, and pain], participant-reported, symptom index) with scores ranging from 0 to 100 (0=no discomfort; 100=maximal discomfort) and lower scores indicate a better outcome.	Baseline to Day 84