Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers
Overview
- Phase
- Phase 4
- Intervention
- Lifitegrast 5% Ophthalmic Solution
- Conditions
- Dry Eye
- Sponsor
- State University of New York College of Optometry
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- last year
Overview
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).
Investigators
Danielle Iacono
Associate Clinical Professor
State University of New York College of Optometry
Eligibility Criteria
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:
- •High tear osmolarity \> 308 mOsm/L, (milliosmoles per liter) or a difference greater than 8 mOsm/L between eyes
- •Any corneal staining
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
Arms & Interventions
Lifitegrast Ophthalmic Solution 5%
Intervention: Lifitegrast 5% Ophthalmic Solution
Lifitegrast Ophthalmic Solution Vehicle
Intervention: Lifitegrast Ophthalmic Solution Vehicle
Outcomes
Primary Outcomes
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
Time Frame: 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 Outcomes
- Change in Total Score on the CLDEQ- 8 From Baseline to 2 Weeks(2 weeks)
- Change in Total Score on the CLDEQ- 8 From Baseline to 4 Weeks(4 weeks)
- Change in Tear Osmolarity OD (Right Eye) From Baseline to Week 8(8 weeks)
- Change in Tear Osmolarity OS (Left Eye) From Baseline to Week 8(8 weeks)
- Forced Choice Questionnaire(8 weeks)
- Change in Score for Each Question on the CLDEQ-8 From Baseline to Week 8(8 weeks)