Status:
COMPLETED
24-Hour Intraocular Pressure Control With Bimatoprost/Timolol Versus Latanoprost as First Choice
Lead Sponsor:
Aristotle University Of Thessaloniki
Conditions:
Glaucoma
Eligibility:
All Genders
21-80 years
Phase:
PHASE4
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, Ganf...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01448837
Start Date
April 1 2010
End Date
March 1 2011
Last Update
May 12 2014
Active Locations (1)
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1
Glaucoma Unit, 1st University Department of Ophthalmology
Thessaloniki, Greece