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

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.
 
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:
Information provided by (Responsible Party):
Takeda ( Shire )

Study Description
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Brief Summary:
Evaluate the efficacy and safety of Lifitegrast in subjects with dry eye disease and a recent history of artificial tear use.

Condition or disease Intervention/treatment Phase
Dry Eye Disease Drug: Lifitegrast Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 711 participants
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
Actual Study Start Date : November 6, 2014
Actual Primary Completion Date : October 5, 2015
Actual Study Completion Date : October 5, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases
Drug Information available for: Lifitegrast

Arms and Interventions
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Arm Intervention/treatment
Experimental: Lifitegrast
Lifitegrast Ophthalmic Solution 5%, BID for 84 days
 Drug: Lifitegrast
Lifitegrast Ophthalmic Solution 5%, BID for 84 days
Placebo Comparator: Placebo
Placebo to match active treatment, BID for 84 days
 Drug: Placebo
Placebo to match active treatment, BID for 84 days


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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


Locations
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Sponsors and Collaborators
Shire
Investigators
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Study Director: Study Director Takeda
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT02284516    
Other Study ID Numbers: SHP606-304
First Posted: November 6, 2014    Key Record Dates
Results First Posted: March 15, 2017
Last Update Posted: June 11, 2021
Last Verified: June 2021
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Eye Diseases
Lacrimal Apparatus Diseases
Keratoconjunctivitis
Conjunctivitis
 Conjunctival Diseases
Keratitis
Corneal Diseases
Lifitegrast
Ophthalmic Solutions
Pharmaceutical Solutions