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

Phase 4

Completed

Conditions: Dry Eye

Interventions: Other: Lifitegrast Ophthalmic Solution Vehicle
Drug: Lifitegrast 5% Ophthalmic Solution

Registration Number: NCT05505292

Lead Sponsor: State University of New York College of Optometry

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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 32

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 (Contact Lens Dry Eye Questionnaire-8) at baseline
Subjects must have at least 2 of the following signs of dry eye disease:
1. High tear osmolarity > 308 mOsm/L, (milliosmoles per liter) or a difference greater than 8 mOsm/L between eyes
2. Any corneal staining
3. Any bulbar conjunctival staining
4. Low TBUT (tear break up time) (<10s)
5. 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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifitegrast Ophthalmic Solution Vehicle	Lifitegrast Ophthalmic Solution Vehicle	-
Lifitegrast Ophthalmic Solution 5%	Lifitegrast 5% Ophthalmic Solution	-

Primary Outcome Measures

Name	Time	Method
Efficacy of Lifitegrast Ophthalmic Solution 5% in Treating the Symptoms of Dry Eye in Contact Lens Wearers as Measured by Change in Total CLDEQ-8 Score From Baseline to Week 8	8 weeks	Measured by change in total score on the CLDEQ-8 (Contact Lens Dry Eye Questionnaire) in subjects using lifitegrast ophthalmic solution as compared to subjects using lifitegrast ophthalmic solution vehicle from baseline to week 8. The CLDEQ-8 (Contact Lens Dry Eye Questionnaire) is a symptom questionnaire that assesses discomfort related to dry eye in contact lens wearers. The minimum possible CLDEQ-8 score is 0. The maximum possible CLDEQ-8 score is 37. Therefore, the maximum change is +/- 37. A negative change is an improvement in symptoms (a lower score at week 8 than baseline).

Secondary Outcome Measures

Name	Time	Method
Change in Total Score on the CLDEQ- 8 From Baseline to 2 Weeks	2 weeks	Measured by change in total score on the CLDEQ-8 (Contact Lens Dry Eye Questionnaire) in subjects using lifitegrast ophthalmic solution as compared to subjects using lifitegrast ophthalmic solution vehicle from baseline to week 2. The CLDEQ-8 (Contact Lens Dry Eye Questionnaire) is a symptom questionnaire that assesses discomfort related to dry eye in contact lens wearers. The minimum possible CLDEQ-8 score is 0. The maximum possible CLDEQ-8 score is 37. Therefore, the maximum change is +/- 37. A negative change is an improvement in symptoms (a lower score at week 2 than baseline).
Change in Total Score on the CLDEQ- 8 From Baseline to 4 Weeks	4 weeks	Measured by change in total score on the CLDEQ-8 (Contact Lens Dry Eye Questionnaire) in subjects using lifitegrast ophthalmic solution as compared to subjects using lifitegrast ophthalmic solution vehicle from baseline to week 4. The CLDEQ-8 (Contact Lens Dry Eye Questionnaire) is a symptom questionnaire that assesses discomfort related to dry eye in contact lens wearers. The minimum possible CLDEQ-8 score is 0. The maximum possible CLDEQ-8 score is 37. Therefore, the maximum change is +/- 37. A negative change is an improvement in symptoms (a lower score at week 4 than baseline).
Change in Tear Osmolarity OD (Right Eye) From Baseline to Week 8	8 weeks	Change in tear osmolarity (as measured by the TearLab device) from baseline to week 8 in the lifitegrast 5% group compared to subjects using lifitegrast ophthalmic solution vehicle. Measured in mOsm/L. A negative change is a lower osmolarity at week 8, which would be an improvement.
Change in Tear Osmolarity OS (Left Eye) From Baseline to Week 8	8 weeks	Change in tear osmolarity (as measured by the TearLab device) from baseline to week 8 in the lifitegrast 5% group compared to subjects using lifitegrast ophthalmic solution vehicle. Measured in mOsm/L. A negative change is a lower osmolarity at week 8, which would be an improvement.
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 Score for Each Question on the CLDEQ-8 From Baseline to Week 8	8 weeks	Measured by change in score for each Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) question in subjects using lifitegrast ophthalmic solution compared to subjects using lifitegrast ophthalmic solution vehicle. A negative change for a question from baseline to week 8 is an improvement in symptom frequency or intensity. Questions are for the past 2 weeks. Questions 1a, 2a, 3a \& 4 ask about frequency of eye discomfort when wearing contacts, eye dryness, changeable, blurry vision in contacts and wanting to close your eyes. Scale: 0=Never, 1=Rarely, 2=Sometimes, 3=Frequently, 4=Constantly Questions 1b, 2b \& 3b ask about the intensity of symptoms at the end of contact lens wearing time noted for questions 1a, 2a and 3a. Scale: 0-5, 0=Never have it, 5=Very Intense Question 5 asks how often did your eyes bother you so much that you felt you needed to take out your contact lenses. Scale: 1=Never, 2=Less than once a week, 3=Weekly, 4=Several times a week, 5=Daily, 6=Several times a day