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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00926185
First Posted: June 23, 2009
Last Update Posted: March 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Shire
  Purpose
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.

Condition Intervention Phase
Dry Eye Drug: Lifitegrast Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Inferior Corneal Fluorescein Staining Score in Pre-Controlled Adverse Environment at Day 84 [ Time Frame: 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.


Secondary Outcome Measures:
  • Inferior Corneal Staining Score Change From Baseline (CFB) to Day 84 [ Time Frame: Baseline (Day 0) and 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.


Enrollment: 230
Study Start Date: June 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo Ophthalmic Solution
Drug: Placebo
Ophthalmic Solution
Experimental: 0.1% Lifitegrast
Lifitegrast
Drug: Lifitegrast
Ophthalmic Solution
Other Name: SAR 1118
Experimental: 1.0% Lifitegrast
Lifitegrast
Drug: Lifitegrast
Ophthalmic Solution
Other Name: SAR 1118
Experimental: 5.0% Lifitegrast
Lifitegrast
Drug: Lifitegrast
Ophthalmic Solution
Other Name: SAR 1118

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00926185


Locations
United States, Connecticut
The Eye Care Group
Waterbury, Connecticut, United States, 06708
United States, Maine
Central Maine Eye Care
Lewiston, Maine, United States, 04243
United States, Massachusetts
Ora, Inc. (two locations)
Andover, Massachusetts, United States, 01840
United States, North Carolina
Mundorf Eye Center
Charlotte, North Carolina, United States, 28204
United States, Tennessee
Total Eye Care, P.A.
Memphis, Tennessee, United States, 38119
Sponsors and Collaborators
Shire
Investigators
Principal Investigator: Gail Torkildsen, MD ORA, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00926185     History of Changes
Other Study ID Numbers: 1118-KCS-100
First Submitted: June 20, 2009
First Posted: June 23, 2009
Results First Submitted: August 9, 2016
Results First Posted: March 6, 2017
Last Update Posted: March 6, 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
Lifitegrast
Pharmaceutical Solutions
Ophthalmic Solutions