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Completed

NCT Number: NCT02284516

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

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

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Alabama at Birmingham, UAB School of Optometry, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lifitegrast

Drug

Lifitegrast Ophthalmic Solution 5%, BID for 84 days

Placebo

Drug

Placebo to match active treatment, BID for 84 days

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study 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

Acronym: OPUS-3

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 6, 2014
Registry last updated
Jun 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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