Phase 4
N=30
Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers
Dry Eye
Bottom Line
View on ClinicalTrials.gov: NCT05505292 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: 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 — -4; -5 units on a scale — p=0.69
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lifitegrast 5% Ophthalmic Solution (Drug); Lifitegrast Ophthalmic Solution Vehicle (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- State University of New York College of Optometry
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
-4; -5 | 0.69 |
| SECONDARY Change in Total Score on the CLDEQ- 8 From Baseline to 2 Weeks |
-3.2; -3.93 | 0.66 |
| SECONDARY Change in Total Score on the CLDEQ- 8 From Baseline to 4 Weeks |
-3.53; -5.6 | 0.23 |
| SECONDARY Change in Tear Osmolarity OD (Right Eye) From Baseline to Week 8 |
-1; -1 | 0.84 |
| SECONDARY Change in Tear Osmolarity OS (Left Eye) From Baseline to Week 8 |
6; 0 | 0.68 |
| SECONDARY Forced Choice Questionnaire |
8; 4; 7; 11 | 0.14 |
| SECONDARY Change in Score for Each Question on the CLDEQ-8 From Baseline to Week 8 |
-1; -1; -1; -1; -1; -1 | 0.62 |
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).
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
- 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.
Data sourced from ClinicalTrials.gov (NCT05505292). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.