Switching From the Preserved to the Preservative - Free Latanoprost - Timolol FC in Glaucoma Patients With OSD
Status:
Recruiting
Trial end date:
2021-12-08
Target enrollment:
Participant gender:
Summary
Glaucoma is a group of chronic eye diseases that are characterized by a progressive optic
nerve damage and consequent visual loss. In most cases, it is associated with elevated
intraocular pressure. If glaucoma left untreated, complete blindness can occur. Prostaglandin
analog- timolol FCs are common glaucoma therapy because these drugs have been shown to
effectively lower intraocular pressure (IOP). It is also known that chronic use of
preservatives in the drops leads to ocular surface disease (OSD) which can lead to low
tolerability of prescribed drops and gaps in the dosing regimen.
The purpose of this study is to investigate whether drug preservative elimination results in
reduction of OSD symptoms and signs as well as improvement of latanoprost-timolol FC local
tolerability in the treatment of glaucoma and ocular hypertension.
In this trial, on each visit (V1, V2 and V3) following tests will be used: Snellen visual
acuity, IOP measurement by Goldman applanation tonometry, OSD signs assessment on the slit
lamp (corneal and conjunctival fluorescein surface staining, conjunctival hyperemia and tear
film stability assessment using Tear Break- up Time test - TBUT). Visual Analog Scale (VAS)
will be used for a subjective assessment of drug tolerability. The association of quality of
life and dry eye symptoms in participants will be measured by the Ocular Surface Disease
Index (OSDI) questionnaire.