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

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).

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Other: Lifitegrast Ophthalmic Solution Vehicle; Drug: Lifitegrast 5% Ophthalmic Solution

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10036
      • State University of New York College of Optometry Clinical Vision Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subjects must read, understand and sign the Statement of Informed Consent
2. Subjects must be at least 18 years of age
3. Subjects must be habitual soft contact lens (CL) wearers, with a daily, weekly, bi- weekly or monthly replacement schedule
4. Habitual contact lenses must have a suitable fit as determined by the investigator
5. 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
6. Subjects must be willing to discontinue the use of Artificial Tears (ATs) and rewetting drops for the duration of the study
7. Subjects must have a score of 12 or higher on the CLDEQ (Contact Lens Dry Eye Questionnaire-8) at baseline

8. 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
9. 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.
10. Subjects currently wearing reusable contact lenses must be willing to use Clear Care solution for cleaning and disinfecting throughout the study.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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).	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Total Score on the CLDEQ- 8 From Baseline to 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).	2 weeks
Change in Total Score on the CLDEQ- 8 From Baseline to 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).	4 weeks
Change in Tear Osmolarity OD (Right Eye) From Baseline to Week 8	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.	8 weeks
Change in Tear Osmolarity OS (Left Eye) From Baseline to Week 8	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.	8 weeks
Forced Choice Questionnaire	Forced choice questionnaire asking if the participant felt that their symptoms improved to the point that they would continue treatment outside of the study	8 weeks
Change in Score for Each Question on the CLDEQ-8 From Baseline to Week 8	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	8 weeks

Collaborators and Investigators

• Sponsor: State University of New York College of Optometry
• Collaborators: Novartis Pharmaceuticals; Bausch & Lomb Incorporated
• Investigators: Principal Investigator: Danielle Iacono, OD, State University of New York College of Optometry

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2022
• Primary Completion (Actual): May 15, 2023
• Study Completion (Actual): May 15, 2023

Study Registration Dates

• First Submitted: August 16, 2022
• First Submitted That Met QC Criteria: August 16, 2022
• First Posted (Actual): August 17, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 10, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Dry Eye; Soft Contact Lenses
• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pharmaceutical Solutions; Ophthalmic Solutions; Lifitegrast
• Other Study ID Numbers: 1449068

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No