Lifitegrast 5% Ophthalmic Solution and Contact Lens Dryness

September 26, 2018 updated by: Agustin Gonzalez, EV Clinical Trials

Safety and Efficacy of Lifitegrast 5% Ophthalmic Solution in Contact Lens Discomfort

The most common reason for contact lens discontinuation is contact lens discomfort. The investigators believe that inflammation plays a role in contact lens discomfort and the use of lifitegrast 5% ophthalmic solution may reduce end of the day contact lens discomfort. This study will enroll 21 contact lens users who will be receiving lifitegrast 5% ophthalmic solution and monitor the contact lens discomfort for a 8 week period while.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Contact lens discontinuation is mostly associated with ocular discomfort. Most patients identifying dryness as the primary reason for contact lens discontinuation. Patients often resort to contact lens solutions, lubricating and/or rewetting drops to temporality improve their contact lens wearing experience. Clinicians often resort to changing contact lens designs, solutions and wearing modalities to improve comfort.

Contact lens discomfort is believed to be mediated by many factors including inflammation and very similar in clinical symptoms of dry eye disease and symptoms of dryness.

Lifitegrast 5.0% ophthalmic solution is an FDA approved solution for the management of signs and symptoms of dryness of dry eye disease. Studies have shown lifitegrast 5% ophthalmic solution may work by blocking the interaction between ICAM-1 and LFA-1 leading to a decrease in activation and recruitment of T-cells, an initial step in inflammation.

The safety and efficacy of Xiidra has been studied in four, 12 week clinical trials involving over 2,100 patients for signs (https://www.xiidra-ecp.com/efficacy-treating-signs) and symptoms (https://www.xiidra-ecp.com/efficacy-symptom-improvement).

The purpose of this open label, interventional study is to examine the effect of lifitegrast 5% ophthalmic solution in contact lens wearing experience by using the CLDEQ-8.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Richardson, Texas, United States, 75082
        • Eye & Vision

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Agree with study protocol
  2. Provide Informed Consent
  3. Age 21 or over
  4. Previous 10 months history of self-assessed comfortable wear samfilcon A contact lenses

Exclusion Criteria:

  1. Unable or unwilling to comply with study protocol
  2. Unable of unwilling to provide Informed consent
  3. Self-reported symptomatic intolerance of contact lenses
  4. History of an active anterior segment, eyelids, eyelashes, corneal or conjunctival pathology, ongoing ocular infection, inflammation or any other ocular problem that would require management with additional topical ophthalmic medications.

  5. Have had a history of corneal surgery (corneal transplants, LASIK, PRK).

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention Group
Lifitegrast 5% ophthalmic solution group
Drug: Lifitegrast
Lifitegrast used twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in CLDEQ-8 scores as reported by study participants
Time Frame: baseline to week 8
measured changes in CLDEQ-8 scores as reported by study participants
baseline to week 8
Lisamine (corneal, conjunctiva) staining scores
Time Frame: baseline to week 8
Lisamine score using the Oxford-Schema scoring
baseline to week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Acuity
Time Frame: Baseline to week 8
Best corrected visual acuity measured by Snellen chart
Baseline to week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EV Clinical Trials

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 16, 2016

Primary Completion (ACTUAL)

July 14, 2017

Study Completion (ACTUAL)

July 14, 2017

Study Registration Dates

First Submitted

September 18, 2018

First Submitted That Met QC Criteria

September 25, 2018

First Posted (ACTUAL)

September 27, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 28, 2018

Last Update Submitted That Met QC Criteria

September 26, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LF5-CLD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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