Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers

Sponsor

State University of New York College of Optometry (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05505292

Collaborator

Novartis Pharmaceuticals (Industry)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective, single site, randomized, double masked, comparator-controlled study designed to evaluate the efficacy of lifitegrast ophthalmic solution 5% in treating the symptoms of dry eye in soft contact lens wearers as compared to control. We hypothesize that there will be a significant improvement in dry eye symptoms in contact lens wearers using lifitegrast as compared to those being treated with control (lifitegrast vehicle).

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Drug: Lifitegrast 5% Ophthalmic Solution Other: Lifitegrast Ophthalmic Solution Vehicle	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Lifitegrast Ophthalmic Solution Vehicle	Other: Lifitegrast Ophthalmic Solution Vehicle Dosed twice a day for 8 weeks
Experimental: Lifitegrast Ophthalmic Solution 5%	Drug: Lifitegrast 5% Ophthalmic Solution Dosed twice a day for 8 weeks Other Names: Xiidra

Arm

Intervention/Treatment

Placebo Comparator: Lifitegrast Ophthalmic Solution Vehicle

Other: Lifitegrast Ophthalmic Solution Vehicle

Dosed twice a day for 8 weeks

Experimental: Lifitegrast Ophthalmic Solution 5%

Drug: Lifitegrast 5% Ophthalmic Solution

Dosed twice a day for 8 weeks

Other Names:

Xiidra

Outcome Measures

Primary Outcome Measures

Efficacy of lifitegrast ophthalmic solution 5% in treating the symptoms of dry eye in contact lens wearers [8 weeks]
Measured by change in total score on the CLDEQ-8 (Contact Lens Dry Eye Questionnaire) as compared to subjects using lifitegrast ophthalmic solution vehicle

Secondary Outcome Measures

Change in tear osmolarity [8 weeks]
Change in tear osmolarity at 8 weeks in the lifitegrast 5% group compared to subjects using lifitegrast ophthalmic solution vehicle
Forced choice questionnaire [8 weeks]
Forced choice questionnaire asking if the participant felt that their symptoms improved to the point that they would continue treatment outside of the study
Change in total score on the CLDEQ- 8 at 2 weeks and 4 weeks [2 weeks and 4 weeks]
Measured by change in total score on the CLDEQ-8 in subjects using lifitegrast ophthalmic solution as compared to subjects using lifitegrast ophthalmic solution vehicle
Trends in responses to individual questions on the CLDEQ-8 [2 weeks, 4 weeks, 8 weeks]
Measured by change in total score on the CLDEQ-8 in subjects using lifitegrast ophthalmic solution as compared to subjects using lifitegrast ophthalmic solution vehicle

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects must read, understand and sign the Statement of Informed Consent
Subjects must be at least 18 years of age
Subjects must be habitual soft contact lens (CL) wearers, with a daily, weekly, bi- weekly or monthly replacement schedule
Habitual contact lenses must have a suitable fit as determined by the investigator
Subjects must report a history of dry eye symptoms, for which they have used rewetting drops or Artificial Tears (ATs) in the past 30 days
Subjects must be willing to discontinue the use of Artificial Tears (ATs) and rewetting drops for the duration of the study
Subjects must have a score of 12 or higher on the CLDEQ at baseline
Subjects must have at least 2 of the following signs of dry eye disease:
High tear osmolarity > 308 mOsm/L, (milliosmoles per liter) or a difference greater than 8 mOsm/L between eyes
Any corneal staining
Any bulbar conjunctival staining
Low TBUT (tear break up time) (<10s)
Schirmer <10mm in either eye
Subjects must be able to read at least half of the 20/25 (via entrance Snellen visual acuity) or better in each eye in their current contact lens prescription.
Subjects currently wearing reusable contact lenses must be willing to use Clear Care solution for cleaning and disinfecting throughout the study.

Exclusion Criteria:

Currently pregnant or breastfeeding by self-report
Allergy to lifitegrast ophthalmic solution 5% (Xiidra)
Habitual extended wear contact lens schedule
Any active ocular disease that may affect the ocular surface other than dry eye (significant blepharitis, allergic conjunctivitis, lagophthalmos, chalazia, hordeolum etc.)
Any meibomian gland dysfunction, blepharitis, corneal neovascularization or papillary conjunctivitis that is grade 3 or higher using the Efron Grading Scale.
Excessive corneal staining, that in the opinion of the investigator, is a contraindication to contact lens use.
History of ocular surgery
Any active ocular infection
Use of any topical ophthalmic medications other than artificial tears or rewetting drops
Inability to perform necessary visual function assessments
Punctal plug insertion in the last 3 months, or presence of punctal plugs at the time of the exam.