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Completed

NCT Number: NCT03686878

Lifitegrast 5% Ophthalmic Solution and Contact Lens Dryness

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.

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Key information

Conditions

Contact Lens Conjunctival Diseases Conjunctivitis Contact Lens Discomfort Contact Lens Dryness Corneal Diseases Dry Eye Syndromes Eye Diseases Keratitis Keratoconjunctivitis Keratoconjunctivitis Sicca Lacrimal Apparatus Diseases Xerophthalmia

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Eye & Vision

Richardson, Texas, 75082, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Unable or unwilling to comply with study protocol
  • Unable of unwilling to provide Informed consent
  • Self-reported symptomatic intolerance of contact lenses
  • 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.
  • Have had a history of corneal surgery (corneal transplants, LASIK, PRK).

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Treatment and study plan

Lifitegrast

Drug

Lifitegrast used twice a day

Primary outcomes

  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 outcomes

  1. Visual Acuity

    Time frame: Baseline to week 8

    Best corrected visual acuity measured by Snellen chart

Sponsors and collaborators

Lead sponsor

EV Clinical Trials

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 27, 2018
Registry last updated
Sep 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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