Ocular Hypertension H40.1
Conditions
Interventions
Group 1: Aim is to switch preserved prostaglandin analog- timolol FC in the period of three months in patients with ocular hypertension and open angle glaucoma who exhibit ocular surface disease (OSD)
Sponsors
Department of Ophthalmology, University hospital center Zagreb
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Adult (?18years) patients • With open angle galucoma or ocular hypertension that had been controlled (stable IOP <19mmHg) by commercially available preserved PGA –timolol FC for at least 3 months • Stable visual field (based on at least two reliable visual field tests performed within the last 12 months) • Central corneal thickness within the range 500-580µm. • mild to moderate hyperaemia based on MacMonnies (scores 1 and 2)
Exclusion criteria
Exclusion criteria: • Best-corrected visual acuity (BCVA) 0,1 or lower • Severe visual field defects (MD 12 dB or higher) • Any intraocular surgery (other than filtration surgery performed at least 6 months before screening) • Any ocular surface abnormality preventing accurate IOP measurement • Acute ocular inflammation • Contact lens wearers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy in reducing the symptoms and signs of ocular surface disease: In the study, on each visit every month (V1, V2 and V3) following tests will be performed: Snellen visual acuity, IOP measurement by Goldman applanation tonometry, OSD signs assessment on the slit lamp (fluorescein corneal and conjunctival fluorescein surface staining, conjunctival hyperemia and tear film stability assessment using Tear Break- up Time test -TBUT). The subjective evaluation of drug tolerability will be quantified by Visual Analog Scale (VAS). The evaluation of the association of quality of life and dry eye symptoms in respondents will be examined with the Ocular Surface Disease Index (OSDI) questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. evaluating efficacy in IOP reduction, 2. evaluating improvement of local tolerability | — |
Countries
Croatia
Contacts
Public ContactSonja Jandrokovic
Department of Ophthalmology, University hospital center Zagreb
Outcome results
None listed