RECRUITINGPhase 3INTERVENTIONAL

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

Combination of 0.09% Cyclosporine and Intense Pulsed Light (IPL) Therapy for the Treatment of Dry Eye Disease in Symptomatic Contact Lens Wearers: a Sham-Controlled Randomized Clinical Trial

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Soft silicone-hydrogel contact lens wearers - Monthly, 2-weeks, opr daily replacement schedule of contact lens - Minimum wear of contact lens for 1 day/week and 4 hours consecutive - f-CLDEQ-8 score ≥ 12 Who Should NOT Join This Trial: - Past usage of cyclosporine 0.09% (Cequa) - Use of another ophthalmic cyclosporine drop in the past 6 months - Known intolerance to cyclosporine - Pregnancy or breastfeeding (or planned pregnancy in the duration study) - History of ocular herpes simplex infection - Active ocular infectious condition - Usage of photosensitizing medication - Epilepsy - History of skin cancer in the IPL treatment zone - Tattoo/pigmented lesion/keloid scars in the IPL treatment zone - Refractive surgery in the past 12 months - In-clinic thermal pulsation eyelid treatment in the past 12 months - Usage of glaucoma drops - Regular continuous wear of contact lenses (including sleep) - Excessive movement or decentration of the contact lenses (assessed at first visit) - Giant papillary conjunctivitis Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Soft silicone-hydrogel contact lens wearers * Monthly, 2-weeks, opr daily replacement schedule of contact lens * Minimum wear of contact lens for 1 day/week and 4 hours consecutive * f-CLDEQ-8 score ≥ 12 Exclusion Criteria: * Past usage of cyclosporine 0.09% (Cequa) * Use of another ophthalmic cyclosporine drop in the past 6 months * Known intolerance to cyclosporine * Pregnancy or breastfeeding (or planned pregnancy in the duration study) * History of ocular herpes simplex infection * Active ocular infectious condition * Usage of photosensitizing medication * Epilepsy * History of skin cancer in the IPL treatment zone * Tattoo/pigmented lesion/keloid scars in the IPL treatment zone * Refractive surgery in the past 12 months * In-clinic thermal pulsation eyelid treatment in the past 12 months * Usage of glaucoma drops * Regular continuous wear of contact lenses (including sleep) * Excessive movement or decentration of the contact lenses (assessed at first visit) * Giant papillary conjunctivitis

Treatments Being Tested

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.

Locations (1)

Opto-Réseau Sherbrooke Est

Sherbrooke, Quebec, Canada