Status:
COMPLETED
24-Hour Intraocular Pressure With Brinzolamide/Timolol Versus Brimonidine/Timolol
Lead Sponsor:
Aristotle University Of Thessaloniki
Collaborating Sponsors:
Alcon Research
Conditions:
Glaucoma
Eligibility:
All Genders
29-80 years
Phase:
PHASE4
Brief Summary
The proposed crossover study will compare for the first time the quality of 24-hour intraocular pressure control with the combination of travoprost and brinzolamide/timolol compared with travoprost an...
Eligibility Criteria
Inclusion
- Patient has open-angle glaucoma and is older than 29 years
- Patients should exhibit typical disc, or field changes and an untreated morning IOP greater than 25 mm Hg
- Patients are treated for at least 3 months with travoprost and should have demonstrated at least a 20% morning IOP reduction
- Patient deemed by PI to require adjunctive therapy to obtain desired target IOP
- Patient should exhibit IOP greater than 18 mm Hg on travoprost monotherapy (2 separate IOP readings at 10:00)
- Patient has mild to moderate glaucoma (field loss more than 16 dB; cupping 0.8 or less)
- Distance best corrected Snellen visual acuity at least 0.1
- No contraindications to travoprost, brimonidine, brinzolamide and β-blockers
- No history of lack of response (\<10% morning IOP reduction) to any medication
- Patient can understand the instructions and adhere to medications
Exclusion
- Female patient of childbearing potential or lactating mother
- History of trauma, inflammation, surgery
- History of past use of steroids (within 2 months), severe dry eyes and use of contact lenses
- Signs of ocular infection, except blepharitis
- Evidence of corneal abnormality that may affect IOP measurements etc
- Closed angle
- History of non-compliance
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00981786
Start Date
August 1 2009
End Date
December 1 2010
Last Update
December 17 2020
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