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Immunosuppressant

Cyclosporine + Intense Pulsed Light 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

Must not have

Active ocular infectious condition

Past usage of cyclosporine 0.09% (Cequa)

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Pivotal 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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I currently have an eye infection.

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I have used cyclosporine 0.09% eye drops before.

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I have epilepsy.

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I am taking medication that increases my sensitivity to light.

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I have had a thermal eyelid treatment in the clinic within the last year.

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I have had skin cancer in the area to be treated with IPL.

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I have tattoos, colored spots, or thick scars in the area to be treated.

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I use eye drops for glaucoma.

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I have been diagnosed with giant papillary conjunctivitis.

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I have had eye surgery to correct my vision in the last year.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Contact lens dry eye symptoms

Secondary study objectives

Adverse effects

Artificial tear usage while wearing contact lenses

Average number of hours spent wearing contact lenses

+11 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 10Eligibility criteria met