A Study Evaluating the Efficacy of SAR 1118 (0.1%, 1.0%, 5.0%) Ophthalmic Solution in Subjects With Dry Eye

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT00926185
First received: June 20, 2009
Last updated: April 25, 2014
Last verified: April 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:
  • Sign: Corneal fluorescein staining before CAE exposure [ Time Frame: Prospective ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptoms: Ocular symptoms pre- and post-chamber [ Time Frame: Prospective ] [ Designated as safety issue: No ]
  • Signs: Ocular Signs pre- & post-chamber; Additional evaluations of dry eye including fluorescein staining, lissamine green staining, conjunctival redness, TFBUT, blink rate, OPI, STT & corneal sensitivity [ Time Frame: Prospective ] [ Designated as safety issue: No ]
  • Safety across treatment groups [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Shire

Additional 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
Study First Received: June 20, 2009
Last Updated: April 25, 2014
Health Authority: United States: Food and Drug Administration

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
Pharmaceutical Solutions
Ophthalmic Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014