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)

NCT00926185 | Completed Phase 2 Results

• 1 other identifier: 1118-KCS-100
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Dry Eye

Keywords

Dry Eye; ophthalmic delivery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Inferior Corneal Staining Score Change From Baseline (CFB) to Day 84

  Baseline (Day 0) and Day 84

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo Ophthalmic Solution

Drug: Placebo

0.1% Lifitegrast

EXPERIMENTAL

Lifitegrast

Drug: Lifitegrast

1.0% Lifitegrast

EXPERIMENTAL

Lifitegrast

Drug: Lifitegrast

5.0% Lifitegrast

EXPERIMENTAL

Lifitegrast

Drug: Lifitegrast

Interventions

Lifitegrast DRUG

Ophthalmic Solution

Also known as: SAR 1118

0.1% Lifitegrast; 1.0% Lifitegrast; 5.0% Lifitegrast

Placebo DRUG

Ophthalmic Solution

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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 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

Sponsors & Collaborators

• Shire: lead

Study Sites (5)

The Eye Care Group

Waterbury, Connecticut, 06708, United States

Location

Central Maine Eye Care

Lewiston, Maine, 04243, United States

Location

Ora, Inc. (two locations)

Andover, Massachusetts, 01840, United States

Location

Mundorf Eye Center

Charlotte, North Carolina, 28204, United States

Location

Total Eye Care, P.A.

Memphis, Tennessee, 38119, United States

Location

Related Publications (1)

• 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.

  PMID: 22330307 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

lifitegrast

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Study Director
• Organization: Shire (Note: Lifitegrast was divested to Novartis in 2019)

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: June 20, 2009
• First Posted: June 23, 2009
• Study Start: August 3, 2009
• Primary Completion: February 18, 2010
• Study Completion: February 18, 2010
• Last Updated: August 9, 2021
• Results First Posted: March 6, 2017

Record last verified: 2021-08

Locations

US (5)