Cyclosporine and Intense Pulsed Light for Dry Eye in Contact Lens Users (NCT06392438) | Clinical Trial Compass
UnknownPhase 3
Cyclosporine and Intense Pulsed Light for Dry Eye in Contact Lens Users
Canada44 participantsStarted 2024-04-25
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Contact lens dry eye symptoms
Timeframe: Measured at each visit (Baseline, week 8, week 11, week 14 and week 16)