Combination of 0.09% cyclosporine and IPL therapy for the treatment of dry eye disease in symptomatic contact lens wearers: study protocol for a sham-controlled randomized clinical trial

Background: Discomfort while using soft contact lenses is a major concern in eyecare, and it is strongly linked to dry eye. Many new dry eye therapies have not yet been studied on contact lens users. Cyclosporine is a pharmaceutical agent that has recently been re-engineered in a nanomicellar drop. Intense pulsed light is a potent treatment for meibomian gland dysfunction. Very little data exists on the effects of these treatments, and they have never been tested in combination. The aim of this study was to test the effects of the combination of nanomicellar cyclosporine and intense pulsed light on the symptoms and signs of soft contact lens users. Methods: A minimum of 44 symptomatic soft contact lens users will be recruited from a primary care optometry practice. They will receive cyclosporine 0.09% to use twice daily, and, after 8 weeks, they will be randomized to receive three sessions of intense pulsed light or a sham. Primary outcome will be the symptom score using a questionnaire, and secondary outcomes will include tear film stability measurements (both on the tear film and over contact lenses), tear meniscus height, osmolarity, meibomian gland atrophy, and ocular surface staining. Safety will be assessed measuring visual acuity, intra-ocular pressure, and an adverse effects questionnaire. Questionnaire scores will be compared using a t-test, while other measurements will be analyzed using mixed-model effects. Discussion: This study aims to test whether a combination of novel dry eye treatments that target the whole tear film improves comfort while wearing contact lenses. Discomfort is a major issue that leads to drop out. The results of this study could provide eyecare professionals with additional tools to help their patients and could open the discussion on future solutions to improve contact lens users’ experience. Trial Registration: Clinicaltrials.gov, NCT06392438, registered on April 23 ^rd , 2024 https://clinicaltrials.gov/study/NCT06392438