A Phase 3 Study to Evaluate the Efficacy of Lifitegrast in Subjects With Dry Eye

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
SARcode Bioscience
ClinicalTrials.gov Identifier:
NCT01743729
First received: December 3, 2012
Last updated: January 15, 2014
Last verified: January 2014

December 3, 2012
January 15, 2014
December 2012
October 2013   (final data collection date for primary outcome measure)
  • Corneal staining score [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Patient-reported dryness score [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Safety and tolerability of lifitegrast 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 NCT01743729 on ClinicalTrials.gov Archive Site
  • Corneal fluorescein score [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Conjunctival lissamine staining [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Eye discomfort scores [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Phase 3 Study to Evaluate the Efficacy of Lifitegrast in Subjects With Dry Eye
A Phase 3, Multicenter, Randomized, Double-Masked and Placebo-Controlled Study Evaluating the Efficacy of a 5.0% Concentration of Lifitegrast Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Currently Using Artificial Tears (OPUS-2)

The purpose of the study is to evaluate the safety and efficacy of lifitegrast ophthalmic solution compared to placebo in the treatment of dry eye.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Dry Eye
  • Drug: Lifitegrast
    Lifitegrast Ophthalmic Solution 5.0%
    Other Name: SAR 1118
  • Drug: Placebo
    Placebo for Lifitegrast Ophthalmic Solution 5.0%
  • Experimental: Lifitegrast
    Lifitegrast Ophthalmic Solution (5.0%)
    Intervention: Drug: Lifitegrast
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
720
October 2013
October 2013   (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
  • A negative urine pregnancy test if female of childbearing potential and must use adequate birth control throughout the study period
  • Artificial tear use within the past 30 days

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 first visit and for the duration of the study
  • 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 prohibited medications at any time during the study unless otherwise specified
  • 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 first visit, and/or any other ocular surgical procedure within 12 months prior to first visit; 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
 
NCT01743729
1118-DRY-300
No
SARcode Bioscience
SARcode Bioscience
Not Provided
Study Director: Charles Semba, MD SARcode Bioscience
SARcode Bioscience
January 2014

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