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Cyclosporine and Intense Pulsed Light for Dry Eye in Contact Lens Users

NCT06392438 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-05-01

No results posted yet for this study

Summary

In this study, two treatments typically used for dry eye disease will be tried for contact lens users to see if their symptoms when they use their contact lenses get better. Cyclosporine is a drop that is used for long-term management of the inflammation and Intense pulsed light (IPL) is a treatment done in a clinic to improve the health of the eyelid glands. The main question in this study is:

Does the combined treatment of cyclosporine and IPL improve the symptoms and the dry eye signs of contact lens wearers?

All the participants will receive the cyclosporine drops for 4 months twice a day. The research team will split the group of participants in two, half receiving the real IPL treatment and half receiving a sham IPL treatment during the last two months of the study. This will allow to compare the two groups to see how IPL helped. The dry eye tests will be done at the start of the study, after two months and after 4 months. The tests will include a dry eye symptoms questionnaire, measures on the tears, the structures of the front of the eye and the eyelids.

Conditions

  • Dry Eye
  • Contact Lens Complication

Interventions

DRUG

CycloSPORINE Ophthalmic

Unidose of Cequa provided without charge to the participant. 1 drop in each eye morning and evening.

PROCEDURE

Intense Pulsed Light

Appropriate eye patches and IPL gel will be applied. 15 triggers per passage will be applied from the right temple to the left temple (7 shots from the right temple to the right nose wing, 1 on the nose bridge and 7 shots from the left nose wing to the left temple). 2 passage/session will be applied.

PROCEDURE

Sham Intense Pulse Light

Appropriate eye patches and IPL gel will be applied. 15 triggers per passage will be applied with the plastic blocker mounted on the IPL prism from the right temple to the left temple (7 shots from the right temple to the right nose wing, 1 on the nose bridge and 7 shots from the left nose wing to the left temple). 2 passage/session will be applied.

Sponsors & Collaborators

  • Université de Sherbrooke

    lead OTHER

Principal Investigators

  • Patrick Boissy, PhD · Professor University of Sherbrooke

  • Langis Michaud, OD, MSc · Professor University of Montreal

  • Eric Lortie-Milner, OD · PhD candidate University of Sherbrooke

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-25
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • Canada

Study Locations

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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 NCT06392438 on ClinicalTrials.gov