Lifitegrast 5% Ophthalmic Solution and Contact Lens Dryness
NCT ID: NCT03686878
Last Updated: 2018-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
21 participants
INTERVENTIONAL
2016-12-16
2017-07-14
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Intervention Group
Lifitegrast 5% ophthalmic solution group
Lifitegrast
Lifitegrast used twice a day
Interventions
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Lifitegrast
Lifitegrast used twice a day
Eligibility Criteria
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Inclusion Criteria
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
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).
\-
21 Years
ALL
Yes
Sponsors
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EV Clinical Trials
OTHER
Responsible Party
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Agustin Gonzalez
Principal Investigator
Locations
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Eye & Vision
Richardson, Texas, United States
Countries
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References
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Efron N. Contact lens wear is intrinsically inflammatory. Clin Exp Optom. 2017 Jan;100(1):3-19. doi: 10.1111/cxo.12487. Epub 2016 Nov 2.
Godin MR, Gupta PK. Lifitegrast ophthalmic solution in the treatment of signs and symptoms of dry eye disease: design, development, and place in therapy. Clin Ophthalmol. 2017 May 22;11:951-957. doi: 10.2147/OPTH.S117188. eCollection 2017.
Nichols JJ, Willcox MD, Bron AJ, Belmonte C, Ciolino JB, Craig JP, Dogru M, Foulks GN, Jones L, Nelson JD, Nichols KK, Purslow C, Schaumberg DA, Stapleton F, Sullivan DA; members of the TFOS International Workshop on Contact Lens Discomfort. The TFOS International Workshop on Contact Lens Discomfort: executive summary. Invest Ophthalmol Vis Sci. 2013 Oct 18;54(11):TFOS7-TFOS13. doi: 10.1167/iovs.13-13212. No abstract available.
Other Identifiers
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LF5-CLD
Identifier Type: -
Identifier Source: org_study_id