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

NCT05505292 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 1449068
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Keywords

Dry Eye; Soft Contact Lenses

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in Total Score on the CLDEQ- 8 From Baseline to 2 Weeks

  2 weeks

• Change in Total Score on the CLDEQ- 8 From Baseline to 4 Weeks

  4 weeks

• Change in Tear Osmolarity OD (Right Eye) From Baseline to Week 8

  8 weeks

• Change in Tear Osmolarity OS (Left Eye) From Baseline to Week 8

  8 weeks

• Forced Choice Questionnaire

  8 weeks

Study Arms (2)

Lifitegrast Ophthalmic Solution Vehicle

PLACEBO COMPARATOR

Other: Lifitegrast Ophthalmic Solution Vehicle

Lifitegrast Ophthalmic Solution 5%

EXPERIMENTAL

Drug: Lifitegrast 5% Ophthalmic Solution

Interventions

Lifitegrast 5% Ophthalmic Solution DRUG

Dosed twice a day for 8 weeks

Also known as: Xiidra

Lifitegrast Ophthalmic Solution 5%

Lifitegrast Ophthalmic Solution Vehicle OTHER

Dosed twice a day for 8 weeks

Lifitegrast Ophthalmic Solution Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• State University of New York College of Optometry: lead
• Novartis Pharmaceuticals: collaborator
• Bausch & Lomb Incorporated: collaborator

Study Sites (1)

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

New York, New York, 10036, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

lifitegrast; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Results Point of Contact

• Title: Danielle Iacono
• Organization: SUNY College of Optometry

diacono@sunyopt.edu

2129385936

Study Officials

• Danielle Iacono, OD

  State University of New York College of Optometry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 17, 2022
• Study Start: September 22, 2022
• Primary Completion: May 15, 2023
• Study Completion: May 15, 2023
• Last Updated: January 14, 2025
• Results First Posted: January 14, 2025

Record last verified: 2025-01

Locations

US (1)