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)

• ClinicalTrials.gov Identifier: NCT00926185
• Recruitment Status: Completed
• First Posted: June 23, 2009
• Results First Posted: March 6, 2017
• Last Update Posted: August 9, 2021
• Sponsor: Shire
• Information provided by (Responsible Party): Takeda ( Shire )

Tracking Information

• First Submitted Date: June 20, 2009
• First Posted Date: June 23, 2009
• Results First Submitted Date: August 9, 2016
• Results First Posted Date: March 6, 2017
• Last Update Posted Date: August 9, 2021
• Actual Study Start Date: August 3, 2009
• Actual Primary Completion Date: February 18, 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 11, 2017)

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.

• Original Primary Outcome Measures (submitted: June 22, 2009): Sign: Corneal fluorescein staining before CAE exposure [ Time Frame: Prospective ]

Current Secondary Outcome Measures (submitted: January 11, 2017)

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.

Original Secondary Outcome Measures (submitted: June 22, 2009)

• Symptoms: Ocular symptoms pre- and post-chamber [ Time Frame: Prospective ]
• 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 ]
• Safety across treatment groups [ Time Frame: Prospective ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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)
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Dry Eye

Intervention

• Drug: Lifitegrast
  Ophthalmic Solution
  Other Name: SAR 1118
• Drug: Placebo
  Ophthalmic Solution

Study Arms

• Placebo Comparator: Placebo
  Placebo Ophthalmic Solution
  Intervention: Drug: Placebo
• Experimental: 0.1% Lifitegrast
  Lifitegrast
  Intervention: Drug: Lifitegrast
• Experimental: 1.0% Lifitegrast
  Lifitegrast
  Intervention: Drug: Lifitegrast
• Experimental: 5.0% Lifitegrast
  Lifitegrast
  Intervention: Drug: Lifitegrast

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 2, 2010): 230
• Original Estimated Enrollment (submitted: June 22, 2009): 228
• Actual Study Completion Date: February 18, 2010
• Actual Primary Completion Date: February 18, 2010 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00926185
• Other Study ID Numbers: 1118-KCS-100
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Takeda ( Shire )
• Original Responsible Party: Director of Clinical Operations, SARcode
• Current Study Sponsor: Shire
• Original Study Sponsor: SARcode Bioscience
• Collaborators: Not Provided

Investigators

• Study Director: Study Director; Takeda

• PRS Account: Takeda
• Verification Date: August 2021