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

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05505292
• Other study ID #: 1449068
• Status: Completed
• Phase: Phase 4
• Start date: September 22, 2022
• Est. completion date: May 15, 2023

Study information

• Verified date: August 2023
• Source: State University of New York College of Optometry
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 15, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 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.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Lifitegrast 5% Ophthalmic Solution
Dosed twice a day for 8 weeks

Other:
• Lifitegrast Ophthalmic Solution Vehicle
Dosed twice a day for 8 weeks

Locations

Country	Name	City	State
United States	State University of New York College of Optometry Clinical Vision Research Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
State University of New York College of Optometry	Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of lifitegrast ophthalmic solution 5% in treating the symptoms of dry eye in contact lens wearers	Measured by change in total score on the CLDEQ-8 (Contact Lens Dry Eye Questionnaire) as compared to subjects using lifitegrast ophthalmic solution vehicle	8 weeks
Secondary	Change in tear osmolarity	Change in tear osmolarity at 8 weeks in the lifitegrast 5% group compared to subjects using lifitegrast ophthalmic solution vehicle	8 weeks
Secondary	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
Secondary	Change in total score on the CLDEQ- 8 at 2 weeks and 4 weeks	Measured by change in total score on the CLDEQ-8 in subjects using lifitegrast ophthalmic solution as compared to subjects using lifitegrast ophthalmic solution vehicle	2 weeks and 4 weeks
Secondary	Trends in responses to individual questions on the CLDEQ-8	Measured by change in total score on the CLDEQ-8 in subjects using lifitegrast ophthalmic solution as compared to subjects using lifitegrast ophthalmic solution vehicle	2 weeks, 4 weeks, 8 weeks