ArticleTrials2026
Combination of 0.09% cyclosporine and intense pulsed light (IPL) therapy for the treatment of dry eye disease in symptomatic contact lens wearers: study protocol for a sham-controlled randomized clinical trial.
Article in Trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06392438 (Combination of 0.09% Cyclosporine and Intense Pulsed Light), which is not on this map. Not yet cited in PubMed.
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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
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Authors and funding
4 authors.
Funding
Abstract
backgroundDiscomfort 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.
methodsForty-four 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 by 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 registrationClinicalTrials.gov NCT06392438 , registered on April 23rd, 2024.
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