A Study to Evaluate Efficacy and Safety of Lifitegrast in Subjects With Dry Eye (OPUS-3) (OPUS-3)

• ClinicalTrials.gov Identifier: NCT02284516
• Recruitment Status: Completed
• First Posted: November 6, 2014
• Results First Posted: March 15, 2017
• Last Update Posted: June 11, 2021
• Sponsor: Shire
• Information provided by (Responsible Party): Takeda ( Shire )

Tracking Information

• First Submitted Date: October 30, 2014
• First Posted Date: November 6, 2014
• Results First Submitted Date: September 30, 2016
• Results First Posted Date: March 15, 2017
• Last Update Posted Date: June 11, 2021
• Actual Study Start Date: November 6, 2014
• Actual Primary Completion Date: October 5, 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 24, 2017)

Change From Baseline in Patient-Reported Eye Dryness Score to Day 84 [ Time Frame: Baseline to Day 84 ]

Eye dryness score was scored on a Visual Analogue Scale (VAS) ranges from 0-100 (0=no discomfort; 100=maximal discomfort).

• Original Primary Outcome Measures (submitted: November 3, 2014): Patient-Reported Eye Dryness Score [ Time Frame: Week 12 ]

Current Secondary Outcome Measures (submitted: January 24, 2017)

Change From Baseline in Patient-Reported Eye Dryness Score to Day 14 and Day 42 [ Time Frame: Baseline to Day 14 and Day 42 ]

Eye dryness score was scored on a Visual Analogue Scale (VAS) ranges from 0-100 (0=no discomfort; 100=maximal discomfort).

Original Secondary Outcome Measures (submitted: November 3, 2014)

• Patient-Reported Eye Dryness Score [ Time Frame: Weeks 2 and 6 ]
• Patient-Reported Eye Discomfort Score [ Time Frame: Week 12 ]
• Patient-Reported Symptom Scores [ Time Frame: Week 12 ]
• Adverse Events [ Time Frame: Screening to Day 84 ]

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

Descriptive Information

• Brief Title: A Study to Evaluate Efficacy and Safety of Lifitegrast in Subjects With Dry Eye (OPUS-3)
• Official Title: A Phase 3, Multicenter, Randomized, Double-masked, and Placebo-controlled Study Evaluating the Efficacy and Safety of a 5.0% Concentration of Lifitegrast Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease and History of Recent Artificial Tear Use
• Brief Summary: Evaluate the efficacy and safety of Lifitegrast in subjects with dry eye disease and a recent history of artificial tear use.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Dry Eye Disease

Intervention

• Drug: Lifitegrast
  Lifitegrast Ophthalmic Solution 5%, BID for 84 days
• Drug: Placebo
  Placebo to match active treatment, BID for 84 days

Study Arms

• Experimental: Lifitegrast
  Lifitegrast Ophthalmic Solution 5%, BID for 84 days
  Intervention: Drug: Lifitegrast
• Placebo Comparator: Placebo
  Placebo to match active treatment, BID for 84 days
  Intervention: Drug: Placebo

Publications *

• Holland EJ, Jackson MA, Donnenfeld E, Piccolo R, Cohen A, Barabino S, Rolando M, Figueiredo FC. Efficacy of Lifitegrast Ophthalmic Solution, 5.0%, in Patients With Moderate to Severe Dry Eye Disease: A Post Hoc Analysis of 2 Randomized Clinical Trials. JAMA Ophthalmol. 2021 Nov 1;139(11):1200-1208. doi: 10.1001/jamaophthalmol.2021.3943.
• Holland EJ, Luchs J, Karpecki PM, Nichols KK, Jackson MA, Sall K, Tauber J, Roy M, Raychaudhuri A, Shojaei A. Lifitegrast for the Treatment of Dry Eye Disease: Results of a Phase III, Randomized, Double-Masked, Placebo-Controlled Trial (OPUS-3). Ophthalmology. 2017 Jan;124(1):53-60. doi: 10.1016/j.ophtha.2016.09.025. Epub 2016 Oct 27.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 24, 2017): 711
• Original Estimated Enrollment (submitted: November 3, 2014): 700
• Actual Study Completion Date: October 5, 2015
• Actual Primary Completion Date: October 5, 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patient-reported history of Dry Eye Disease in both eyes.
• Use of over the counter artificial tears within the past 30 days.
• A negative urine pregnancy test for females and willingness to use adequate birth control throughout the study.
• Able and willing to comply with all study procedures.

Exclusion Criteria:

• Presence of an ocular condition that could affect the study parameters such as active ocular infections, ocular inflammation, glaucoma, or diabetic retinopathy;.
• Unwilling to stop wearing contact lenses during the study.
• LASIK or other ocular surgical procedures within 12 months prior to or during the study.
• Use of prohibited medications
• Significant medical conditions that could affect the study parameters.

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: NCT02284516
• Other Study ID Numbers: SHP606-304
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Takeda ( Shire )
• Original Responsible Party: Same as current
• Current Study Sponsor: Shire
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Study Director; Takeda

• PRS Account: Takeda
• Verification Date: June 2021