Safety and Efficacy Study of SAR 1118 to Treat Dry Eye (OPUS-1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
SARcode Bioscience
ClinicalTrials.gov Identifier:
NCT01421498
First received: August 17, 2011
Last updated: July 2, 2013
Last verified: July 2013
  Purpose

The purpose of the study is to evaluate the efficacy of SAR 1118 Ophthalmic Solution (5.0%) compared to placebo in the treatment of Dry Eye. The safety and tolerability of SAR 1118 Ophthalmic Solution (5.0%) compared to placebo in subjects with dry eye when administered BID for 12 weeks will also be evaluated.


Condition Intervention Phase
Dry Eye
Keratoconjunctivitis Sicca
Drug: Lifitegrast
Phase 3

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 3, Multicenter, Randomized, Double- Masked and Placebo-Controlled Study Evaluating the Efficacy of a 5.0% Concentration of SAR 1118 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye (OPUS-1)

Resource links provided by NLM:


Further study details as provided by SARcode Bioscience:

Primary Outcome Measures:
  • Inferior Corneal Fluorescein Staining [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Visual-related function subscale of OSDI [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Safety and tolerability of SAR 1118 Ophthalmic Solution (5.0%) compared to placebo, including incidence and severity of ocular and non-ocular adverse events. [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Schirmer Tear Test [ Time Frame: Week 2, 12 ] [ Designated as safety issue: No ]
  • Total Corneal Staining [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • OSDI Score [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Ocular Discomfort Score [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Enrollment: 588
Study Start Date: August 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 5.0% Lifitegrast
Lifitegrast
Drug: Lifitegrast
Dosage Form: Ophthalmic Solution Dosage: placebo, 5.0% Frequency: BID Duration: 12 weeks
Other Name: SAR 1118
Placebo Comparator: Placebo Drug: Lifitegrast
Dosage Form: Ophthalmic Solution Dosage: placebo, 5.0% Frequency: BID Duration: 12 weeks
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:

  • Willing and able to read, sign, and date the informed consent and HIPAA documents
  • 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 artificial tear substitutes) 72 hrs prior to Visit 1 and during the study
  • Any significant chronic 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
  • Subjects with Dry eye secondary to scarring or destruction of conjunctival goblet cells (as with Vitamin A deficiency)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01421498

Locations
United States, Connecticut
OPUS-1 Investigational Site
Waterbury, Connecticut, United States, 06708
United States, Kentucky
OPUS-1 Investigational Site
Louisville, Kentucky, United States, 40405
United States, Maine
OPUS-1 Investigational Site
Augusta, Maine, United States, 04330
OPUS-1 Investigational Site
Lewiston, Maine, United States, 04243
United States, Massachusetts
OPUS-1 Investigational Site
Andover, Massachusetts, United States, 01840
OPUS-1 Investigational Site
Lancaster, Massachusetts, United States, 01523
OPUS-1 Investigational Site
Quincy, Massachusetts, United States, 02169
OPUS-1 Investigational Site
Wakefield, Massachusetts, United States, 01880
OPUS-1 Investigational Site
Winchester, Massachusetts, United States, 01890
United States, New Hampshire
OPUS-1 Investigational Site
Derry, New Hampshire, United States, 03038
OPUS-1 Investigational Site
Manchester, New Hampshire, United States, 03101
United States, Tennessee
OPUS-1 Investigational Site
Memphis, Tennessee, United States, 38119
United States, Virginia
OPUS-1 Investigational Site
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
SARcode Bioscience
Investigators
Study Director: Charles Semba, MD SARcode Bioscience, Inc.
  More Information

No publications provided

Responsible Party: SARcode Bioscience
ClinicalTrials.gov Identifier: NCT01421498     History of Changes
Other Study ID Numbers: 1118-KCS-200
Study First Received: August 17, 2011
Last Updated: July 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by SARcode Bioscience:
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

ClinicalTrials.gov processed this record on April 17, 2014