An interventional study of Assessment of ocular surface staining (Oxford score 0-15 scale) and mean diurnal intraocular pressure-lowering in Glaucoma and Ocular Surface Disease, sponsored by Aristotle University Of Thessaloniki. Completed at 1 site in Greece. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2022-07-20.
Sponsored by Aristotle University Of Thessaloniki · Not applicable, Interventional, and Prevention
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.
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This study's enrollment of 42 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.
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Exclusion criteria
In this arm subjects will be randomized to topical therapy comprising preservative-free tafluprost drops dosed in the evening (20:30) and dorzolamide/timolol fixed combination drops administered twice daily (8:00 and 20:00). Patients will use placebo (artificial tears) in the evening (21:00) for 6 months. At the end of this period patients will be crossed over to the other therapy (cyclosporine 0.1% in the evening)
Diagnostic Test: Assessment of ocular surface staining (Oxford score 0-15 scale) · Drug: mean diurnal intraocular pressure-lowering
In this arm subjects will be randomized to topical therapy comprising preservative-free tafluprost drops dosed in the evening (20:30) and dorzolamide/timolol fixed combination drops administered twice daily (8:00 and 20:00). Patients will use cyclosporine 0.1% drops in the evening (21:00) for 6 months. At the end of this period all patients will be crossed over to the other therapy (placebo in the evening)
Diagnostic Test: Assessment of ocular surface staining (Oxford score 0-15 scale) · Drug: mean diurnal intraocular pressure-lowering
Corneal and conjunctiva staining will be recorded according to the Oxford grading scheme for ocular staining (0-15 score).
At the end of each 6-month period patients will undergo diurnal intraocular pressure assessment with both therapies.
Mean change from baseline in ocular staining (Oxford score)
The primary efficacy endpoint for this crossover study will be the mean change from baseline in the total ocular staining score as determined by the 15-point Oxford scale of staining on the study eye.
Time frame: 6 months
Mean diurnal IOP
Mean diurnal intraocular pressure with the two preservative-free therapies versus preserved baseline will be evaluated as secondary endpoint.
Time frame: 6 months
Osmolarity
Mean tear osmolarity with the two PF therapies versus preserved baseline will be evaluated as secondary endpoint.
Time frame: 6-months
Matrix-metalloproteinase-9 (MMP-9) over-expression
Mean MMP-9 over-expression with the two PF therapies versus preserved baseline will be evaluated as secondary endpoint.
Time frame: 6 months
Plan to share: No
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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Aristotle University Of Thessaloniki