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

NCT05505292 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-01-14

Study results available
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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

Interventions

DRUG

Lifitegrast 5% Ophthalmic Solution

Dosed twice a day for 8 weeks

OTHER

Lifitegrast Ophthalmic Solution Vehicle

Dosed twice a day for 8 weeks

Sponsors & Collaborators

  • Novartis Pharmaceuticals

    collaborator INDUSTRY

  • Bausch & Lomb Incorporated

    collaborator INDUSTRY

  • State University of New York College of Optometry

    lead OTHER

Principal Investigators

  • Danielle Iacono, OD · State University of New York College of Optometry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-22
Primary Completion
2023-05-15
Completion
2023-05-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05505292 on ClinicalTrials.gov