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
Abstract
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: Forty-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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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