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Immunosuppressant

IPL group for Dry Eye Syndrome (CycliP Trial)

Phase 3

Recruiting

Led By Eric Lortie-Milner, OD

Research Sponsored by Université de Sherbrooke

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 8, week 11, week 14, and week 16

Awards & highlights

CycliP Trial Summary

This trial will test if a combination of cyclosporine eye drops and Intense Pulsed Light (IPL) treatment can improve symptoms and signs of dry eye in contact lens wearers

Who is the study for?

This trial is for contact lens users who suffer from dry eye syndrome. Participants should be willing to use cyclosporine drops twice daily and undergo IPL treatments. Those with certain eye conditions or who have had recent eye surgery may not qualify.Check my eligibility

What is being tested?

The study tests if using cyclosporine eye drops in combination with Intense Pulsed Light (IPL) therapy can improve dry eyes in contact lens wearers, compared to those only using the drops and receiving a sham IPL treatment.See study design

What are the potential side effects?

Cyclosporine may cause stinging or burning sensations in the eyes, increased tear production, or redness. IPL could result in mild discomfort during treatment, temporary redness or swelling around the eyes.

CycliP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 8, week 11, week 14, and week 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 8, week 11, week 14, and week 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 8, week 11, week 14, and week 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Contact lens dry eye symptoms

Secondary outcome measures

Adverse effects

Artificial tear usage while wearing contact lenses

Average number of hours spent wearing contact lenses

+11 more

CycliP Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: IPL groupExperimental Treatment2 Interventions

Participants will receive 0.09% cyclosporine drops dosed at bid for 16 weeks. Participants receive 3 IPL sessions at 3-weeks interval in the last 2 months of the study. IPL treatments will be given with Lumenis M22 with a 590nm filter, pulse duration of 6-50ms (3 pulses/trigger) and fluence will be determined after determining the skin type (Fitzpatrick scale) of the participant.

Group II: Sham-IPL groupPlacebo Group2 Interventions

Participants will receive 0.09% cyclosporine drops dosed at bid for 16 weeks. Participants receive 3 IPL sessions at 3-weeks interval in the last 2 months of the study. IPL treatments will be given with Lumenis M22 with a 590nm filter, pulse duration of 6-50ms (3 pulses/trigger) and fluence will be determined set at 10 J/cm2. A plastic filter will recover the IPL prism, preventing the light to reach the skin of the participant.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intense Pulsed Light

2018

Completed Phase 3

~120

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Université de SherbrookeLead Sponsor

298 Previous Clinical Trials

69,897 Total Patients Enrolled

Patrick Boissy, PhDStudy ChairProfessor University of Sherbrooke

2 Previous Clinical Trials

60 Total Patients Enrolled

Langis Michaud, OD, MScStudy DirectorProfessor University of Montreal

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of individuals actively engaged in this medical study?

"Indeed, the details on clinicaltrials.gov reveal that this investigation is actively seeking volunteers. Initially shared on April 25th, 2024, and most recently revised on April 26th, 2024, the trial aims to enroll a total of 44 participants at one designated site."

Answered by AI

Has the IPL group obtained approval from the FDA?

"The safety rating for the IPL group has been evaluated as 3 by our team at Power, indicating a high level of safety assurance due to the trial being in Phase 3 with substantial efficacy and multiple rounds of safety data."

Answered by AI

Are there currently opportunities for individuals to participate in this trial?

"Indeed, information sourced from clinicaltrials.gov confirms the ongoing patient recruitment for this investigation. The trial was first listed on April 25th, 2024 and last modified on April 26th, 2024. Recruitment aims to enroll a total of 44 participants at one designated site."

Answered by AI

Recent research and studies

CorneaJournal

A Randomized Double-masked Study of 0.05% Cyclosporine Ophthalmic Emulsion in the Treatment of Meibomian Gland Dysfunction

Prabhasawat, Pinnita, Nattaporn Tesavibul, and Wannaree Mahawong. 2012. “A Randomized Double-masked Study of 0.05% Cyclosporine Ophthalmic Emulsion in the Treatment of Meibomian Gland Dysfunction”. Cornea. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/ico.0b013e31823cc098.

clinicaltrials.govStudy

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

Patrick Boissy 2024. "Cyclosporine and Intense Pulsed Light for Dry Eye in Contact Lens Users". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06392438.

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