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NCT02284516 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Shire.

Completed
Registry status
Phase 3
Development phase
711
Enrollment target

NCT02284516: Completed Phase 3 study, sponsored by Shire.

NCT02284516 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 711 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02284516, a Phase 3 study, has completed, sponsored by Shire.

COMPLETED
Registry status
Phase 3
Development phase
711 participants
Enrollment target

Study Summary

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

Primary Outcome

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

Interventions

  • DRUG Placebo
  • DRUG Lifitegrast

Trial Details

FieldValue
Enrollment Target 711 participants
Start Date 2014-11-06
Est. Completion 2015-10-05
Phase Phase 3
Shire

245 total trials

What the finished NCT02284516 record still lists

NCT02284516 is an interventional study that assigns participants to a tested intervention. The registered 711 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02284516 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02284516 about?

NCT02284516 is a clinical study titled "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.

What is the current status of trial NCT02284516?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 711 participants. The study started on 2014-11-06. Estimated completion is 2015-10-05.

What interventions are being tested in trial NCT02284516?

The interventions under investigation include: Placebo (DRUG), Lifitegrast (DRUG).

Who is sponsoring clinical trial NCT02284516?

This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02284516's enrollment target sits among peer trials

711 501st of 2000 higher than 1,499 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02284516, the US trial registry maintained by the National Library of Medicine. NCT02284516 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.