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Safety Study of Lifitegrast to Treat Dry Eye

NCT01636206 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 332

Last updated 2021-06-11

Study results available
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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.

Conditions

Interventions

DRUG

Lifitegrast

Dosage Form: Ophthalmic Solution Dosage: 5.0% Frequency: BID Duration: \~1 year

DRUG

Placebo

Dosage Form: Ophthalmic Solution Dosage: placebo Frequency: BID Duration: \~1 year

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-16
Primary Completion
2014-03-03
Completion
2014-03-03

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01636206 on ClinicalTrials.gov