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

NCT ID: NCT05505292

Last Updated: 2025-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-22
• Study Completion Date: 2023-05-15

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).

Conditions

Dry Eye

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lifitegrast Ophthalmic Solution Vehicle

Group Type: PLACEBO_COMPARATOR

Lifitegrast Ophthalmic Solution Vehicle

Intervention Type: OTHER

Dosed twice a day for 8 weeks

Lifitegrast Ophthalmic Solution 5%

Group Type: EXPERIMENTAL

Lifitegrast 5% Ophthalmic Solution

Intervention Type: DRUG

Dosed twice a day for 8 weeks

Interventions

Lifitegrast 5% Ophthalmic Solution

Dosed twice a day for 8 weeks

Intervention Type: DRUG

Lifitegrast Ophthalmic Solution Vehicle

Dosed twice a day for 8 weeks

Intervention Type: OTHER

Other Intervention Names

Xiidra

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: collaborator

State University of New York College of Optometry

OTHER

Sponsor Role: lead

Responsible Party

Danielle Iacono

Associate Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Danielle Iacono, OD

Role: PRINCIPAL_INVESTIGATOR

State University of New York College of Optometry

Locations

State University of New York College of Optometry Clinical Vision Research Center

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1449068

Identifier Type: -

Identifier Source: org_study_id