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
|Condition or disease||Intervention/treatment||Phase|
|Contact Lens Contact Lens Discomfort Contact Lens Dryness||Drug: Lifitegrast||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||21 participants|
|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|
Experimental: Intervention Group
Lifitegrast 5% ophthalmic solution group
Lifitegrast used twice a day
- 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
- Lisamine (corneal, conjunctiva) staining scores [ Time Frame: baseline to week 8 ]Lisamine score using the Oxford-Schema scoring
- Visual Acuity [ Time Frame: Baseline to week 8 ]Best corrected visual acuity measured by Snellen chart
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
|United States, Texas|
|Eye & Vision|
|Richardson, Texas, United States, 75082|