from preserved, to preservative-free cyclosporine 0.1% enhanced triple glaucoma therapy

Conditions: Glaucoma; Ocular Surface Disease

Summary: there is a lack of evidence on the impact of switching from a combined preserved anti-glaucoma regimen to a preservative-free (pf) one, while employing sufficiently robust osd metrics. the investigators have therefore carried out a single center, prospective, crossover investigation to compare the 6-month effect of switching well controlled open-angle glaucoma patients with at least moderate glaucoma therapy-related ocular surface disease from preserved to triple preservative-free therapy with and without cyclosporine 0.1% dosed in the evening.

halting and reversing glaucoma therapy-related ocular surface disease (gtr-osd) will improve the success of long-term medical therapy, impacting millions of patients worldwide. chronic medical therapy for glaucoma may be immensely benefitted by limiting disabling gtr-osd, which would aid in the prevention of blindness. in 2015 a novel cationic formulation of cyclosporine a 0.1% was approved with once in the evening dosing in europe. it is an effective, targeted immunomodulatory compound reducing inflammatory mediators and providing healing of the ocular epithelium. there remains however a paucity of published controlled evidence for gtr-osd patients treated with this formulation. in addition, there is a lack of evidence on the impact of switching from a combined preserved anti-glaucoma regimen, to a preservative-free one, while employing sufficiently robust osd metrics. the investigators have therefore carried out a single center prospective, crossover investigation to compare the 6-month effect of switching well controlled open-angle glaucoma patients with at least moderate gtr-osd, from preserved to triple pf therapy with and without pf cyclosporine 0.1% dosed in the evening.

Eligibility criteria:
inclusion criteria * adult patients with well controlled open-angle glaucoma * patients chronically treated for more than 6 months with preserved, branded, or generic, triple antiglaucoma therapy comprising latanoprost and dorzolamide/timolol fixed combination * subjects should have experienced at least 1 symptom of dry eye (soreness, scratchiness, dryness, grittiness, and burning) * additionally, patients should demonstrate at least one of the objective signs for osd at baseline: positive conjunctival staining with lissamine green and/or evidence of positive corneal staining with fluorescein (assessed with the 15-point oxford scale), * patients must show a but\<8 seconds * on screening patients should show a schirmer test without anesthesia (schirmer-i test) ≥3 and ≤10 mm in 5 minutes. * when both eyes qualify the worse eye will be included in the study. exclusion criteria * best corrected visual acuity \<1/10 * patients with severe dry eye disease or sjogren's disease * presence of eyelid abnormality, corneal disorder or abnormality, ocular surface metaplasia, filamentous keratitis, or corneal neovascularization * patients who have undergone ocular surgery (of any type, including laser surgery), or ocular trauma within 4 months prior to screening * subjects who had punctal occlusion, or diathermy within 3 months prior to screening or abnormality of the nasolacrimal drainage apparatus. * known allergy, or sensitivity to any of the study medications * uncontrolled systemic disease, or history or active signs of ocular trauma, infection, inflammation, allergic disease, or herpes; corneal ulcers; recurrent erosions; or uveitis * female patients will be excluded if they are pregnant, breastfeeding, planning a pregnancy, or are unwilling to use a reliable form of contraception.