Clinical trial NCT05505292: Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers
Official title: Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye
Keywords: Dry Eye
Soft Contact Lenses
Lead sponsor: State University of New York College of Optometry
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
name: Bausch & Lomb Incorporated
First posted: 2022-08-17
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in Total Score on the CLDEQ- 8 From Baseline to 2 Weeks
timeFrame: 2 weeks
measure: Change in Total Score on the CLDEQ- 8 From Baseline to 4 Weeks
timeFrame: 4 weeks
measure: Change in Tear Osmolarity OD (Right Eye) From Baseline to Week 8
timeFrame: 8 weeks
measure: Change in Tear Osmolarity OS (Left Eye) From Baseline to Week 8
timeFrame: 8 weeks
measure: Forced Choice Questionnaire
timeFrame: 8 weeks
measure: Change in Score for Each Question on the CLDEQ-8 From Baseline to Week 8
timeFrame: 8 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: State University of New York College of Optometry Clinical Vision Research Center
state: New York
Study officials:
affiliation: State University of New York College of Optometry
name: Danielle Iacono, OD
role: PRINCIPAL_INVESTIGATOR
References: