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):
Shire
ClinicalTrials.gov Identifier:
NCT01743729
First received: December 3, 2012
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Dry Eye
Drug: Lifitegrast
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Lifitegrast Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Currently Using Artificial Tears (OPUS-2)

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 720
Study Start Date: December 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifitegrast
Lifitegrast Ophthalmic Solution (5.0%)
Drug: Lifitegrast
Lifitegrast Ophthalmic Solution 5.0%
Other Name: SAR 1118
Placebo Comparator: Placebo Drug: Placebo
Placebo for Lifitegrast Ophthalmic Solution 5.0%

  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
  • 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)
  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: NCT01743729

  Show 31 Study Locations
Sponsors and Collaborators
Shire
Investigators
Study Director: Charles Semba, MD SARcode Bioscience
  More Information

No publications provided

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01743729     History of Changes
Other Study ID Numbers: 1118-DRY-300
Study First Received: December 3, 2012
Last Updated: April 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Shire:
SAR 1118

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2014