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Lifitegrast 5% Ophthalmic Solution and Contact Lens Dryness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03686878
Recruitment Status : Completed
First Posted : September 27, 2018
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Agustin Gonzalez, EV Clinical Trials

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Contact Lens Contact Lens Discomfort Contact Lens Dryness Drug: Lifitegrast Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Safety and Efficacy of Lifitegrast 5% Ophthalmic Solution in Contact Lens Discomfort
Actual Study Start Date : December 16, 2016
Actual Primary Completion Date : July 14, 2017
Actual Study Completion Date : July 14, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
Drug Information available for: Lifitegrast

Arm Intervention/treatment
Experimental: Intervention Group
Lifitegrast 5% ophthalmic solution group
Drug: Lifitegrast
Lifitegrast used twice a day




Primary Outcome Measures :
  1. 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

  2. Lisamine (corneal, conjunctiva) staining scores [ Time Frame: baseline to week 8 ]
    Lisamine score using the Oxford-Schema scoring


Secondary Outcome Measures :
  1. Visual Acuity [ Time Frame: Baseline to week 8 ]
    Best corrected visual acuity measured by Snellen chart



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03686878


Locations
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United States, Texas
Eye & Vision
Richardson, Texas, United States, 75082
Sponsors and Collaborators
EV Clinical Trials
Publications:
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Responsible Party: Agustin Gonzalez, Principal Investigator, EV Clinical Trials
ClinicalTrials.gov Identifier: NCT03686878    
Other Study ID Numbers: LF5-CLD
First Posted: September 27, 2018    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018

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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
Keywords provided by Agustin Gonzalez, EV Clinical Trials:
Keratoconjunctivitis Sicca
Dry Eye Disease
Eye Dryness
Additional relevant MeSH terms:
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Lifitegrast
Ophthalmic Solutions
Pharmaceutical Solutions