A Study Evaluating the Efficacy of SAR 1118 (0.1%, 1.0%, 5.0%) Ophthalmic Solution in Subjects With Dry Eye Conducted in a Controlled Adverse Environment (CAE)

A Phase 2, Multicenter, Randomized, Double-Masked and Placebo-Controlled Study Evaluating the Efficacy of Three Different Concentrations (0.1%, 1.0%, 5.0%) of SAR 1118 Ophthalmic Solution in Subjects With Dry Eye Using the Controlled Adverse Environment (CAE) Model

The purpose of this study is to evaluate the efficacy of three different concentrations (0.1%, 1.0%, 5.0%) of SAR 1118 Ophthalmic Solution compared to placebo in the treatment of dry eye.

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Drug: Placebo; Drug: Lifitegrast

• Study Type: Interventional
• Enrollment (Actual): 230
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
      • The Eye Care Group
  • Maine
    • Lewiston, Maine, United States, 04243
      • Central Maine Eye Care
  • Massachusetts
    • Andover, Massachusetts, United States, 01840
      • Ora, Inc. (two locations)
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Mundorf Eye Center
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care, P.A.

Participation Criteria

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:

• Signed Informed Consent Form and HIPAA document
• 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 tear substitutes) 72 hrs prior to screening assessments and through the entire study period
• 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 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 5.0% Lifitegrast; Lifitegrast	Drug: Lifitegrast; Ophthalmic Solution; Other Names: SAR 1118
PLACEBO_COMPARATOR: Placebo; Placebo Ophthalmic Solution	Drug: Placebo; Ophthalmic Solution
EXPERIMENTAL: 0.1% Lifitegrast; Lifitegrast	Drug: Lifitegrast; Ophthalmic Solution; Other Names: SAR 1118
EXPERIMENTAL: 1.0% Lifitegrast; Lifitegrast	Drug: Lifitegrast; Ophthalmic Solution; Other Names: SAR 1118

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inferior Corneal Fluorescein Staining Score in Pre-Controlled Adverse Environment at 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; 1=occasional; 2=countable; 3=uncountable, but not confluent; 4=confluent) 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.	Day 84

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inferior Corneal Staining Score Change From Baseline (CFB) 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; 1=occasional; 2=countable; 3=uncountable, but not confluent; 4=confluent) 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) and Day 84

Collaborators and Investigators

• Sponsor: Shire

Publications and helpful links

General Publications

• Semba CP, Torkildsen GL, Lonsdale JD, McLaurin EB, Geffin JA, Mundorf TK, Kennedy KS, Ousler GW. A phase 2 randomized, double-masked, placebo-controlled study of a novel integrin antagonist (SAR 1118) for the treatment of dry eye. Am J Ophthalmol. 2012 Jun;153(6):1050-60.e1. doi: 10.1016/j.ajo.2011.11.003. Epub 2012 Feb 11.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 3, 2009
• Primary Completion (ACTUAL): February 18, 2010
• Study Completion (ACTUAL): February 18, 2010

Study Registration Dates

• First Submitted: June 20, 2009
• First Submitted That Met QC Criteria: June 22, 2009
• First Posted (ESTIMATE): June 23, 2009

Study Record Updates

• Last Update Posted (ACTUAL): August 9, 2021
• Last Update Submitted That Met QC Criteria: August 5, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Dry Eye; ophthalmic delivery
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pharmaceutical Solutions; Ophthalmic Solutions; Lifitegrast
• Other Study ID Numbers: 1118-KCS-100