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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):
Shire
ClinicalTrials.gov Identifier:
NCT01421498
First received: August 17, 2011
Last updated: April 25, 2014
Last verified: April 2014
  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 Shire:

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
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: 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
Shire
Investigators
Study Director: Charles Semba, MD SARcode Bioscience, Inc.
  More Information

No publications provided

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01421498     History of Changes
Other Study ID Numbers: 1118-KCS-200
Study First Received: August 17, 2011
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:
Dry Eye Syndromes
Keratoconjunctivitis
Keratoconjunctivitis Sicca
Conjunctival Diseases
Conjunctivitis
Corneal Diseases
Eye Diseases
Keratitis
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014