Glaucoma
Conditions
Brief summary
The primary objective of this crossover 24-hour Intraocular Pressure (IOP) trial is to compare the control obtained after 3 months of therapy with the bimatoprost/timolol fixed combination (BTFC, Ganfort) given once in the evening (20:00) versus latanoprost (Xalatan) administered once in the evening (20:00) in newly-diagnosed patients with exfoliation syndrome (XFS) and ocular hypertension, or exfoliative glaucoma (XFG) previously untreated and IOP greater than 29 mm Hg.
Interventions
DRUGBimatoprost/Timolol, 24-hour intraocular pressure monitoring
Administered once in the evening
DRUGLatanoprost, 24-hour intraocular pressure monitoring
assessment of 24-hour efficacy for the two drugs after 3 months of chronic dosing
Sponsors
Aristotle University Of Thessaloniki
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patient has exfoliation syndrome with ocular hypertension, or exfoliative glaucoma and is older than 29 years * Patient is newly diagnosed, or currently untreated and exhibits untreated morning IOP (2 separate IOP readings at 10:00)greater than 29 mm Hg in the study eye * Study patients should have mild to moderate exfoliative glaucoma (VF loss \<12 dB; cupping 0.8 or less) * Patient with exfoliation syndrome should fulfill the IOP criterion (IOP \> 29 mm Hg at 10:00) * Patient deemed by investigator to require significant IOP reduction to obtain desired target IOP * Patient agrees to be treated for at least 3 months with latanoprost and bimatoprost/timolol fixed combination drops dosed in the evening * In study eye distance best corrected Snelen visual acuity greater than 1/10
Exclusion criteria
* Contraindications to therapy with latanoprost, bimatoprost, or β-blockers * History of non-adherence or previously recorded evidence of lack of response (\<10% morning IOP reduction) to any antiglaucoma medication * Patient can not understand the instructions and adhere to medications * Patient is a female of childbearing potential or lactating mother * Past history of trauma, inflammation, surgery, past use of steroids (within 2 months), severe dry eyes and use of contact lenses * Signs of ocular infection, except blepharitis, or corneal abnormality that may affect IOP measurements * The other eye can not receive the same therapy, or remain without medical therapy * Closed angles
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24-hour IOP reduction between the two medications | 3 months | Bimatoprost/Timolol will obtain a statistically greater 24-hour IOP reduction than latanoprost and the mean 24-hour IOP difference between the two medications will be clinically meaningful (at least 2 mm Hg). |
Countries
Greece
Outcome results
None listed