Safety and Efficacy Study of SAR 1118 to Treat Dry Eye Conducted in a Controlled Adverse Environment (CAE) (OPUS-1)

Dry Eye Disease Clinical Trial

— OPUS-1  

Official title:

A Phase 3, Multicenter, Randomized, Double- Masked and Placebo-Controlled Study Evaluating the Efficacy of a 5.0% Concentration of SAR 1118 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye (OPUS-1)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01421498
• Other study ID #: 1118-KCS-200
• Status: Completed
• Phase: Phase 3
• Start date: August 29, 2011
• Est. completion date: April 28, 2012

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 efficacy of SAR 1118 Ophthalmic Solution (5.0%) compared to placebo in the treatment of Dry Eye. The safety and tolerability of SAR 1118 Ophthalmic Solution (5.0%) compared to placebo in subjects with dry eye when administered BID for 12 weeks will also be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 588
• Est. completion date: April 28, 2012
• Est. primary completion date: April 28, 2012
• 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

• Demonstrate a positive response when exposed to the Controlled Adverse Environment model

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

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 and for duration of the study period

• 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 topical ophthalmic preparations (including artificial tear substitutes) 72 hrs prior to Visit 1 and during the study

• Any significant chronic 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 Visit 1, and/or any other ocular surgical procedure within 12 months prior to Visit 1; 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
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Lifitegrast
Dosage Form: Ophthalmic Solution Dosage: 5.0% Frequency: BID Duration: 12 weeks
• Placebo
Dosage Form: Ophthalmic Solution Frequency: BID Duration: 12 weeks

Locations

Country	Name	City	State
United States	OPUS-1 Investigational Site	Andover	Massachusetts
United States	OPUS-1 Investigational Site	Augusta	Maine
United States	OPUS-1 Investigational Site	Derry	New Hampshire
United States	OPUS-1 Investigational Site	Lancaster	Massachusetts
United States	OPUS-1 Investigational Site	Lewiston	Maine
United States	OPUS-1 Investigational Site	Louisville	Kentucky
United States	OPUS-1 Investigational Site	Manchester	New Hampshire
United States	OPUS-1 Investigational Site	Memphis	Tennessee
United States	OPUS-1 Investigational Site	Norfolk	Virginia
United States	OPUS-1 Investigational Site	Quincy	Massachusetts
United States	OPUS-1 Investigational Site	Wakefield	Massachusetts
United States	OPUS-1 Investigational Site	Waterbury	Connecticut
United States	OPUS-1 Investigational Site	Winchester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

United States, 

References & Publications (1)

Sheppard JD, Torkildsen GL, Lonsdale JD, D'Ambrosio FA Jr, McLaurin EB, Eiferman RA, Kennedy KS, Semba CP; OPUS-1 Study Group. Lifitegrast ophthalmic solution 5.0% for treatment of dry eye disease: results of the OPUS-1 phase 3 study. Ophthalmology. 2014 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular Sign: Change From Baseline in Inferior Corneal Fluorescein Staining 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 staining was graded with the Ophthalmic Research Associates, Inc. (ORA) scale. 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/none; 1=occasional/trace; 2=countable/mild; 3=uncountable, but not confluent/moderate; 4=confluent/severe) with 0.5 point increments, and lower score indicates a better outcome. 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 (Day 0) to Day 84
Primary	Ocular Symptom: Change From Baseline in Visual-Related Subscale of the Symptom Functional Scale Score to Day 84	The symptom functional scale is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the symptom functional scale questionnaire were graded on a scale of 0 (none of the time) to 4 (all of the time). The index consisted of 3 sub scales: symptoms (sensitivity to light, gritty sensation, pain, blurred vision, and poor vision [Items 1-5]), visual-related sub scale of the symptom functional scale (ability to read, drive at night, use a computer, watch television [Items 6-9]), and environmental triggers (windy conditions, low humidity, air conditioning [Items 10-12]). The symptom functional scale was scored on a scale of 0 to 100, with higher scores representing greater disability. Negative change from baseline indicates improvement.	Baseline (Day 0) to Day 84