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A Phase 3 Study to Evaluate the Efficacy of Lifitegrast in Subjects With Dry Eye

NCT ID: NCT01743729

Last Updated: 2021-06-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

720 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-07

Study Completion Date

2013-10-01

Brief Summary

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The purpose of the study is to evaluate the safety and efficacy of lifitegrast ophthalmic solution compared to placebo in the treatment of dry eye.

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Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers

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Detailed Description

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Conditions

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Dry Eye Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lifitegrast

Lifitegrast Ophthalmic Solution (5.0%)

Group Type EXPERIMENTAL

Lifitegrast

Intervention Type DRUG

Lifitegrast Ophthalmic Solution 5.0%

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo for Lifitegrast Ophthalmic Solution 5.0%

Interventions

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Lifitegrast

Lifitegrast Ophthalmic Solution 5.0%

Intervention Type DRUG

Placebo

Placebo for Lifitegrast Ophthalmic Solution 5.0%

Intervention Type DRUG

Other Intervention Names

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SAR 1118

Eligibility Criteria

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Inclusion Criteria

* Willing and able to read, sign and date the informed consent and HIPAA documents
* Willing and able to comply with all study procedures
* Be at least 18 years of age
* Patient-reported history of dry eye in both eyes
* A negative urine pregnancy test if female of childbearing potential and must use adequate birth control throughout the study period
* Artificial tear use within the past 30 days

Exclusion Criteria

* Any ocular condition that, in the opinion of the Investigator, could affect study parameters including, but not limited to, active ocular infection, ocular inflammation, glaucoma, and/or diabetic retinopathy
* Unwilling to avoid wearing contact lenses for 7 days prior to first visit and for the duration of the study
* Any blood donation or significant loss of blood within 56 days of Visit 1
* Any history of immunodeficiency disorder, positive HIV, hepatitis B, C, or evidence of acute active hepatitis A (anti-HAV IgM), or organ or bone marrow transplant.
* Use of any prohibited medications at any time during the study unless otherwise specified
* Any significant illness that could interfere with study parameters
* History of laser assisted in situ keratomileusis (LASIK) or similar type of corneal refractive surgery within 12 months prior to first visit, and/or any other ocular surgical procedure within 12 months prior to first visit; or any scheduled ocular surgical procedure during the study period.
* Known history of alcohol and/or drug abuse
* Subjects with Dry eye secondary to scarring or destruction of conjunctival goblet cells (as with Vitamin A deficiency)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shire

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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OPUS-2 Investigational Site

Artesia, California, United States

Site Status

OPUS-2 Investigational Site

Hemet, California, United States

Site Status

OPUS-2 Investigational Site

Lancaster, California, United States

Site Status

OPUS-2 Investigational Site

Mission Hills, California, United States

Site Status

OPUS-2 Investigational Site

Montebello, California, United States

Site Status

OPUS-2 Investigational Site

Newport Beach, California, United States

Site Status

OPUS-2 Investigational Site

Petaluma, California, United States

Site Status

OPUS-2 Investigational SIte

Rancho Cordova, California, United States

Site Status

OPUS-2 Investigational Site

Danbury, Connecticut, United States

Site Status

OPUS-2 Investigational Site

Fort Myers, Florida, United States

Site Status

OPUS-2 Investigational Site

Hoffman Estates, Illinois, United States

Site Status

OPUS-2 Investigational Site

Indianapolis, Indiana, United States

Site Status

OPUS-2 Investigational Site

New Albany, Indiana, United States

Site Status

OPUS-2 Investigational Site

Lexington, Kentucky, United States

Site Status

OPUS-2 Investigational Site

Saint Paul, Minnesota, United States

Site Status

OPUS-2 Investigational Site

Chesterfield, Missouri, United States

Site Status

OPUS-2 Investigational Site

Des Peres, Missouri, United States

Site Status

OPUS-2 Investigational Site

Independence, Missouri, United States

Site Status

OPUS-2 Investigational Site

Kansas City, Missouri, United States

Site Status

OPUS-2 Investigational Site

Washington, Missouri, United States

Site Status

OPUS-2 Investigational Site

New York, New York, United States

Site Status

OPUS-2 Investigational Site

New York, New York, United States

Site Status

OPUS-2 Investigational Site

Wantagh, New York, United States

Site Status

OPUS-2 Investigational Site

Cleveland, Ohio, United States

Site Status

OPUS-2 Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

OPUS-2 Investigational Site

Houston, Texas, United States

Site Status

OPUS-2 Investigational Site

Houston, Texas, United States

Site Status

OPUS-2 Investigational Site

League City, Texas, United States

Site Status

OPUS-2 Investigational Site

San Antonio, Texas, United States

Site Status

OPUS-2 Investigational Site

San Antonio, Texas, United States

Site Status

OPUS-2 Investigational Site

Norfolk, Virginia, United States

Site Status

Countries

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United States

References

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Tauber J, Karpecki P, Latkany R, Luchs J, Martel J, Sall K, Raychaudhuri A, Smith V, Semba CP; OPUS-2 Investigators. Lifitegrast Ophthalmic Solution 5.0% versus Placebo for Treatment of Dry Eye Disease: Results of the Randomized Phase III OPUS-2 Study. Ophthalmology. 2015 Dec;122(12):2423-31. doi: 10.1016/j.ophtha.2015.08.001. Epub 2015 Sep 11.

Reference Type RESULT
PMID: 26365210 (View on PubMed)

Other Identifiers

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1118-DRY-300

Identifier Type: -

Identifier Source: org_study_id

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