Safety and Efficacy Study of SAR 1118 to Treat Dry Eye Conducted in a Controlled Adverse Environment (CAE) (OPUS-1)

Last updated: June 2, 2021
Sponsor: Shire
Overall Status: Completed

Phase

3

Condition

Dry Eye Disease

Sjogren's Syndrome

Dry Eyes

Treatment

N/A

Clinical Study ID

NCT01421498
1118-KCS-200
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 Environmentmodel
  • A negative urine pregnancy test if female of childbearing potential and must useadequate birth control throughout the study period

Exclusion

Exclusion Criteria:

  • Any ocular condition that, in the opinion of the Investigator, could affect studyparameters including, but not limited to, active ocular infection, ocularinflammation, glaucoma, and/or diabetic retinopathy
  • Unwilling to avoid wearing contact lenses for 7 days prior to and for duration of thestudy 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 ofacute active hepatitis A (anti-HAV IgM), or organ or bone marrow transplant.
  • Use of any topical ophthalmic preparations (including artificial tear substitutes) 72hrs 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 cornealrefractive surgery within 12 months prior to Visit 1, and/or any other ocular surgicalprocedure within 12 months prior to Visit 1; or any scheduled ocular surgicalprocedure during the study period.
  • Known history of alcohol and/or drug abuse
  • Subjects with Dry eye secondary to scarring or destruction of conjunctival gobletcells (as with Vitamin A deficiency)

Study Design

Total Participants: 588
Study Start date:
August 29, 2011
Estimated Completion Date:
April 28, 2012

Connect with a study center

  • OPUS-1 Investigational Site

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • OPUS-1 Investigational Site

    Waterbury, Connecticut 06708
    United States

    Site Not Available

  • OPUS-1 Investigational Site

    Louisville, Kentucky 40405
    United States

    Site Not Available

  • OPUS-1 Investigational Site

    Augusta, Maine 04330
    United States

    Site Not Available

  • OPUS-1 Investigational Site

    Lewiston, Maine 04243
    United States

    Site Not Available

  • OPUS-1 Investigational Site

    Andover, Massachusetts 01840
    United States

    Site Not Available

  • OPUS-1 Investigational Site

    Lancaster, Massachusetts 01523
    United States

    Site Not Available

  • OPUS-1 Investigational Site

    Quincy, Massachusetts 02169
    United States

    Site Not Available

  • OPUS-1 Investigational Site

    Wakefield, Massachusetts 01880
    United States

    Site Not Available

  • OPUS-1 Investigational Site

    Winchester, Massachusetts 01890
    United States

    Site Not Available

  • OPUS-1 Investigational Site

    Las Vegas, Nevada 89131
    United States

    Site Not Available

  • OPUS-1 Investigational Site

    Derry, New Hampshire 03038
    United States

    Site Not Available

  • OPUS-1 Investigational Site

    Manchester, New Hampshire 03101
    United States

    Site Not Available

  • OPUS-1 Investigational Site

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • OPUS-1 Investigational Site

    Norfolk, Virginia 23502
    United States

    Site Not Available

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