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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: May 28, 2012
Last verified: May 2012
History of Changes

August 17, 2011
May 28, 2012
August 2011
May 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01421498 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study of SAR 1118 to Treat Dry Eye
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)

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Dry Eye
  • Keratoconjunctivitis Sicca
Drug: SAR 1118
Dosage Form: Ophthalmic Solution Dosage: placebo, 5.0% Frequency: BID Duration: 12 weeks
  • Experimental: 5.0% SAR 1118
    Intervention: Drug: SAR 1118
  • Placebo Comparator: Placebo
    Intervention: Drug: SAR 1118
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
588
May 2012
May 2012   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01421498
1118-KCS-200
No
SARcode Bioscience
SARcode Bioscience
Not Provided
Study Director: Charles Semba, MD SARcode Bioscience, Inc.
SARcode Bioscience
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP