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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02284516
First Posted: November 6, 2014
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Shire
  Purpose
Evaluate the efficacy and safety of Lifitegrast in subjects with dry eye disease and a recent history of artificial tear use.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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).


Enrollment: 711
Study Start Date: November 2014
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifitegrast Drug: Lifitegrast
Lifitegrast Ophthalmic Solution 5%, BID for 84 days
Placebo Comparator: Placebo Drug: Placebo
Placebo to match active treatment, BID for 84 days

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02284516


  Show 41 Study Locations
Sponsors and Collaborators
Shire
Investigators
Principal Investigator: Joseph Tauber, MD Tauber Eye Center
  More Information

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT02284516     History of Changes
Other Study ID Numbers: SHP606-304
First Submitted: October 30, 2014
First Posted: November 6, 2014
Results First Submitted: September 30, 2016
Results First Posted: March 15, 2017
Last Update Posted: June 14, 2017
Last Verified: September 2016

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