Open-angle Glaucoma
Conditions
Brief summary
The primary objective of this crossover trial is to compare the 3-month mean 24-hour intraocular pressure (IOP) control and safety of dorzolamide/timolol fixed combination (DTFC) given twice daily, versus latanoprost/timolol fixed combination (LTFC) given in the evening and placebo given in the morning, versus adjunctive therapy with DTFC given twice daily and latanoprost 0.005% given once in the evening in open-angle glaucoma patients who are insufficiently controlled with latanoprost monotherapy.
Interventions
DRUGDrug: dorzolamide/timolol
DRUGDrug: latanoprost/timolol
DRUGdorzolamide/timolol and latanoprost
Sponsors
Aristotle University Of Thessaloniki
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
29 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Consecutive primary open-angle (POAG) and exfoliative glaucoma (XFG) patients will be recruited. * Patients included will be older than 29 years * Have early to moderate POAG, or XFG (less than 12 mean deviation visual field loss attributed to glaucoma and 0.8 or better vertical cup-to-disc ratio) * Will be on therapy with latanoprost for more than 3 months; * Have at treated baseline IOP at 10:00 (two consecutive readings) greater than 21 mm Hg * Have a reliable visual field (at least two visual fields with less than 30% fixation losses, false positives or negatives) * Have a best corrected distance Snellen visual acuity \> 1/10 * Have corneal pachymetry within the 550 ± 55 μm range, understand the study instructions and are willing to attend all follow-up appointments * Are willing to comply with study medication usage * And have open, normal appearing angles
Exclusion criteria
* Patients will be excluded if they have: a risk for significant deterioration during the study * Known previous history of lack of adequate response (\< 10% reduction) to any topical glaucoma medication * Less than 20% daytime IOP reduction on latanoprost; * Systemic contraindications to topical beta-blockers (asthma, bradycardia, severe congestive heart disease) * Known contraindications to prostaglandins, history of ocular herpetic disease, or cystoid macular edema * History of trauma, inflammation, surgery or past use of steroids (within two months) * Severe dry eyes * Use of contact lenses * Signs of ocular infection, except blepharitis * Corneal abnormality that may affect IOP measurements * Unwillingness to accept the risk for hyperchromia of the iris or development of hypertrichosis * And females of childbearing potential or lactating mothers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-hour IOP control with DTFC will be statistically similar with LTFC given once each evening and placebo in the morning. | — |
| Adjunctive therapy with DTFC and latanoprost will provide significantly better 24-hour IOP control than both fixed combinations alone (DTFC and LTFC). | — |
Countries
Greece
Outcome results
None listed