Lifitegrast 5% Ophthalmic Solution and Contact Lens Dryness

• Sponsor: EV Clinical Trials (Other)
• Overall Status: Completed
• CT.gov ID: NCT03686878
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Arm: 1
• Actual Duration (Months): 6.9
• Patients Per Site Per Month: 3

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• 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: Dec 16, 2016
• Actual Primary Completion Date: Jul 14, 2017
• Actual Study Completion Date: Jul 14, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in CLDEQ-8 scores as reported by study participants [baseline to week 8]

   measured changes in CLDEQ-8 scores as reported by study participants

2. Lisamine (corneal, conjunctiva) staining scores [baseline to week 8]

   Lisamine score using the Oxford-Schema scoring

Secondary Outcome Measures

1. Visual Acuity [Baseline to week 8]

   Best corrected visual acuity measured by Snellen chart

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eye & Vision	Richardson	Texas	United States	75082

Sponsors and Collaborators

• EV Clinical Trials

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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. Review.
• 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. Review.
• 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.

• Responsible Party: Agustin Gonzalez, Principal Investigator, EV Clinical Trials
• ClinicalTrials.gov Identifier: NCT03686878
• Other Study ID Numbers: LF5-CLD
• First Posted: Sep 27, 2018
• Last Update Posted: Sep 28, 2018
• Last Verified: Sep 1, 2018

• 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, Principal Investigator, EV Clinical Trials: Keratoconjunctivitis Sicca; Dry Eye Disease; Eye Dryness
• Additional relevant MeSH terms: Lifitegrast

Study Results

No Results Posted as of Sep 28, 2018