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

June 2, 2021 updated by: Shire

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

588

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • OPUS-1 Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40405
        • OPUS-1 Investigational Site
    • Maine
      • Augusta, Maine, United States, 04330
        • OPUS-1 Investigational Site
      • Lewiston, Maine, United States, 04243
        • OPUS-1 Investigational Site
    • Massachusetts
      • Andover, Massachusetts, United States, 01840
        • OPUS-1 Investigational Site
      • Lancaster, Massachusetts, United States, 01523
        • OPUS-1 Investigational Site
      • Quincy, Massachusetts, United States, 02169
        • OPUS-1 Investigational Site
      • Wakefield, Massachusetts, United States, 01880
        • OPUS-1 Investigational Site
      • Winchester, Massachusetts, United States, 01890
        • OPUS-1 Investigational Site
    • New Hampshire
      • Derry, New Hampshire, United States, 03038
        • OPUS-1 Investigational Site
      • Manchester, New Hampshire, United States, 03101
        • OPUS-1 Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • OPUS-1 Investigational Site
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • OPUS-1 Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
Dosage Form: Ophthalmic Solution Frequency: BID Duration: 12 weeks
EXPERIMENTAL: 5.0% Lifitegrast
Lifitegrast
Drug: Lifitegrast
Dosage Form: Ophthalmic Solution Dosage: 5.0% Frequency: BID Duration: 12 weeks
Other Names:
  • SAR 1118

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular Sign: Change From Baseline in Inferior Corneal Fluorescein Staining to Day 84
Time Frame: Baseline (Day 0) 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
Time Frame: Baseline (Day 0) 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 29, 2011

Primary Completion (ACTUAL)

April 28, 2012

Study Completion (ACTUAL)

April 28, 2012

Study Registration Dates

First Submitted

August 17, 2011

First Submitted That Met QC Criteria

August 19, 2011

First Posted (ESTIMATE)

August 22, 2011

Study Record Updates

Last Update Posted (ACTUAL)

June 11, 2021

Last Update Submitted That Met QC Criteria

June 2, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1118-KCS-200

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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