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

• ClinicalTrials.gov Identifier: NCT01743729
• Recruitment Status: Completed
• First Posted: December 6, 2012
• Results First Posted: February 24, 2017
• Last Update Posted: June 23, 2021
• Sponsor: Shire
• Information provided by (Responsible Party): Takeda ( Shire )

Tracking Information

• First Submitted Date: December 3, 2012
• First Posted Date: December 6, 2012
• Results First Submitted Date: August 9, 2016
• Results First Posted Date: February 24, 2017
• Last Update Posted Date: June 23, 2021
• Actual Study Start Date: December 7, 2012
• Actual Primary Completion Date: October 1, 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 5, 2017)

• Change From Baseline in Inferior Corneal Fluorescein Staining Score to Day 84 [ Time Frame: Baseline to Day 84 ]
  Corneal staining was performed to grade the degree of corneal epithelial cell injury as measured by fluorescence using slit-lamp examination. The corneal surface is divided into three regions: superior, central and inferior. The scores for each of these 3 regions ranged from 0 to 4 (0=no staining; 1=few/rare punctate lesions; 2=discrete and countable lesions; 3=lesions too numerous to count, but not coalescent; 4=coalescent) with 0.5 point increments, and lower scores indicate improvement. Inferior corneal fluorescein staining scores from the study eye only were reported. Study eye is the 'worse eye', defined as the eye with worse (higher) score at baseline.
• Change From Baseline in Eye Dryness Score (Visual Analogue Scale) to Day 84 [ Time Frame: Baseline to Day 84 ]
  Eye dryness score was assessed on a visual analogue scale (a 7-item [burning/stinging, itching, foreign body sensation, eye discomfort, eye dryness, photophobia, and pain], participant-reported, symptom index) with scores ranging from 0 to 100 (0=no discomfort; 100=maximal discomfort) and lower scores indicate a better outcome.

Original Primary Outcome Measures (submitted: December 4, 2012)

• Corneal staining score [ Time Frame: Week 12 ]
• Patient-reported dryness score [ Time Frame: Week 12 ]
• 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 ]

• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (submitted: December 4, 2012)

• Corneal fluorescein score [ Time Frame: Week 12 ]
• Conjunctival lissamine staining [ Time Frame: Week 12 ]
• Eye discomfort scores [ Time Frame: Week 12 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Phase 3 Study to Evaluate the Efficacy of Lifitegrast in Subjects With Dry Eye
• 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)
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Dry Eye Disease

Intervention

• Drug: Lifitegrast
  Lifitegrast Ophthalmic Solution 5.0%
  Other Name: SAR 1118
• Drug: Placebo
  Placebo for Lifitegrast Ophthalmic Solution 5.0%

Study Arms

• Experimental: Lifitegrast
  Lifitegrast Ophthalmic Solution (5.0%)
  Intervention: Drug: Lifitegrast
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

• Publications *: Tauber J, Karpecki P, Latkany R, Luchs J, Martel J, Sall K, Raychaudhuri A, Smith V, Semba CP; OPUS-2 Investigators. Lifitegrast Ophthalmic Solution 5.0% versus Placebo for Treatment of Dry Eye Disease: Results of the Randomized Phase III OPUS-2 Study. Ophthalmology. 2015 Dec;122(12):2423-31. doi: 10.1016/j.ophtha.2015.08.001. Epub 2015 Sep 11.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 25, 2013): 720
• Original Estimated Enrollment (submitted: December 4, 2012): 700
• Actual Study Completion Date: October 1, 2013
• Actual Primary Completion Date: October 1, 2013 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01743729
• Other Study ID Numbers: 1118-DRY-300
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Takeda ( Shire )
• Original Responsible Party: SARcode Bioscience
• Current Study Sponsor: Shire
• Original Study Sponsor: SARcode Bioscience
• Collaborators: Not Provided

Investigators

• Study Director: Study Director; Takeda

• PRS Account: Takeda
• Verification Date: June 2021