Safety and Efficacy Study of SAR 1118 to Treat Dry Eye Conducted in a Controlled Adverse Environment (CAE) (OPUS-1)
OPUS-1
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)
1 other identifier
interventional
588
1 country
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2011
Shorter than P25 for phase_3
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2011
CompletedFirst Posted
Study publicly available on registry
August 22, 2011
CompletedStudy Start
First participant enrolled
August 29, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 28, 2012
CompletedResults Posted
Study results publicly available
February 24, 2017
CompletedJune 11, 2021
June 1, 2021
8 months
August 17, 2011
November 9, 2015
June 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (2)
5.0% Lifitegrast
EXPERIMENTALLifitegrast
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Dosage Form: Ophthalmic Solution Dosage: 5.0% Frequency: BID Duration: 12 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (13)
OPUS-1 Investigational Site
Waterbury, Connecticut, 06708, United States
OPUS-1 Investigational Site
Louisville, Kentucky, 40405, United States
OPUS-1 Investigational Site
Augusta, Maine, 04330, United States
OPUS-1 Investigational Site
Lewiston, Maine, 04243, United States
OPUS-1 Investigational Site
Andover, Massachusetts, 01840, United States
OPUS-1 Investigational Site
Lancaster, Massachusetts, 01523, United States
OPUS-1 Investigational Site
Quincy, Massachusetts, 02169, United States
OPUS-1 Investigational Site
Wakefield, Massachusetts, 01880, United States
OPUS-1 Investigational Site
Winchester, Massachusetts, 01890, United States
OPUS-1 Investigational Site
Derry, New Hampshire, 03038, United States
OPUS-1 Investigational Site
Manchester, New Hampshire, 03101, United States
OPUS-1 Investigational Site
Memphis, Tennessee, 38119, United States
OPUS-1 Investigational Site
Norfolk, Virginia, 23502, United States
Related 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 Feb;121(2):475-83. doi: 10.1016/j.ophtha.2013.09.015. Epub 2013 Nov 26.
PMID: 24289915RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Shire (Note: Lifitegrast was divested to Novartis in 2019)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2011
First Posted
August 22, 2011
Study Start
August 29, 2011
Primary Completion
April 28, 2012
Study Completion
April 28, 2012
Last Updated
June 11, 2021
Results First Posted
February 24, 2017
Record last verified: 2021-06