Combining cyclosporine and intense pulsed light for dry eye relief 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
This study is testing if using cyclosporine eye drops along with intense pulsed light therapy can help contact lens wearers feel better from dry eye symptoms.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Université de Sherbrooke Academic / other |
| Locations | 1 site (Sherbrooke, Quebec) |
| Trial ID | NCT06392438 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of combining cyclosporine eye drops with intense pulsed light (IPL) therapy to alleviate dry eye symptoms in contact lens wearers. Participants will receive cyclosporine drops twice daily for four months, while half will also undergo real IPL treatment and the other half a sham treatment during the last two months. The study aims to determine if the combination of these treatments leads to significant improvements in dry eye symptoms and signs. Dry eye assessments will be conducted at the beginning, after two months, and at the end of the study to evaluate the outcomes.
Who should consider this trial
Good fit: Ideal candidates are soft silicone-hydrogel contact lens wearers experiencing dry eye symptoms.
Not a fit: Patients with a history of intolerance to cyclosporine or those who have used it in the past six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for contact lens users suffering from dry eye symptoms.
How similar studies have performed: While there have been studies on each treatment separately, this combined approach is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Sherbrooke, Quebec
- Opto-Réseau Sherbrooke Est — Sherbrooke, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Eric Lortie-Milner, OD — PhD candidate University of Sherbrooke
- Study coordinator: Patrick Boissy, PhD
- Email: patrick.boissy@usherbrooke.ca
- Phone: 819-780-2220
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.