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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Dry Eye; Keratoconjunctivitis Sicca	Drug: Lifitegrast; Drug: Placebo	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	588 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
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)
Study Start Date :	August 2011
Actual Primary Completion Date :	May 2012
Actual Study Completion Date :	May 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: 5.0% Lifitegrast; Lifitegrast	Drug: Lifitegrast; Dosage Form: Ophthalmic Solution Dosage: 5.0% Frequency: BID Duration: 12 weeks; Other Name: SAR 1118
Placebo Comparator: Placebo	Drug: Placebo; Dosage Form: Ophthalmic Solution Frequency: BID Duration: 12 weeks

Outcome Measures

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Primary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

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Locations

United States, Connecticut
OPUS-1 Investigational Site
Waterbury, Connecticut, United States, 06708
United States, Kentucky
OPUS-1 Investigational Site
Louisville, Kentucky, United States, 40405
United States, Maine
OPUS-1 Investigational Site
Augusta, Maine, United States, 04330
OPUS-1 Investigational Site
Lewiston, Maine, United States, 04243
United States, Massachusetts
OPUS-1 Investigational Site
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
United States, New Hampshire
OPUS-1 Investigational Site
Derry, New Hampshire, United States, 03038
OPUS-1 Investigational Site
Manchester, New Hampshire, United States, 03101
United States, Tennessee
OPUS-1 Investigational Site
Memphis, Tennessee, United States, 38119
United States, Virginia
OPUS-1 Investigational Site
Norfolk, Virginia, United States, 23502

Sponsors and Collaborators

Shire

Investigators

Study Director:	Charles Semba, MD	SARcode Bioscience, Inc.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Shire
ClinicalTrials.gov Identifier:	NCT01421498 History of Changes
Other Study ID Numbers:	1118-KCS-200
First Posted:	August 22, 2011
Results First Posted:	February 24, 2017
Last Update Posted:	February 24, 2017
Last Verified:	January 2017

Keywords provided by Shire:

Dry Eye; ophthalmic delivery

Additional relevant MeSH terms:

Keratoconjunctivitis Sicca; Dry Eye Syndromes; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Eye Diseases	Keratitis; Corneal Diseases; Lacrimal Apparatus Diseases; Ophthalmic Solutions; Lifitegrast; Pharmaceutical Solutions