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NCT01636206 · ClinicalTrials.gov registry record · Phase 3

Safety Study of Lifitegrast to Treat Dry Eye

A Phase 3 study, sponsored by Shire.

Completed
Registry status
Phase 3
Development phase
332
Enrollment target

NCT01636206: Completed Phase 3 study, sponsored by Shire.

NCT01636206 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 332 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01636206, a Phase 3 study, has completed, sponsored by Shire.

COMPLETED
Registry status
Phase 3
Development phase
332 participants
Enrollment target

Study Summary

The purpose of the study is to evaluate the safety of lifitegrast ophthalmic solution compared to placebo in the treatment of dry eye as assessed by ocular and non-ocular adverse events when administered BID for approximately 1 year.

Interventions

  • DRUG Placebo
  • DRUG Lifitegrast

Trial Details

FieldValue
Enrollment Target 332 participants
Start Date 2012-10-16
Est. Completion 2014-03-03
Phase Phase 3
Shire

245 total trials

What the finished NCT01636206 record still lists

NCT01636206 is an interventional study that assigns participants to a tested intervention. The registered 332 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% lower).

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

NCT01636206 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01636206 about?

NCT01636206 is a clinical study titled "Safety Study of Lifitegrast to Treat Dry Eye". The purpose of the study is to evaluate the safety of lifitegrast ophthalmic solution compared to placebo in the treatment of dry eye as assessed by ocular and non-ocular adverse events when administered BID for approximately 1 year.

What is the current status of trial NCT01636206?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 332 participants. The study started on 2012-10-16. Estimated completion is 2014-03-03.

What interventions are being tested in trial NCT01636206?

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

Who is sponsoring clinical trial NCT01636206?

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

How this trial's enrollment target compares

Where NCT01636206's enrollment target sits among peer trials

332 1061st of 2000 higher than 935 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 NCT01636206, the US trial registry maintained by the National Library of Medicine. NCT01636206 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.