24-Hour Intraocular Pressure With Brinzolamide/Timolol Versus Brimonidine/Timolol
Information source: Aristotle University Of Thessaloniki
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glaucoma
Intervention: Brimonidine/timolol fixed combination drops added to travoprost (Drug); Brinzolamide/timolol fixed combination drops added to travoprost (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Aristotle University Of Thessaloniki Official(s) and/or principal investigator(s):
Anastasios G Konstas, MD, PhD, Principal Investigator, Affiliation: Glaucoma Unit, 1st University Department of Ophthalmology
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 and brimonidine/timolol in glaucoma patients insufficiently
controlled with travoprost. This comparison may determine the real efficacy of the two fixed
combinations when added to the prostaglandin. The design of the proposed study should
facilitate a better understanding of the role of these medications in glaucoma management.
Clinical Details
Official title: Quality of 24-hour Intraocular Pressure Control Obtained With the Brinzolamide/Timolol Fixed Combination Compared With the Brimonidine/Timolol Fixed Combination When Added to Travoprost Monotherapy in Subjects With Open-angle Glaucoma
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: Mean 24-hour intraocular pressure
Secondary outcome: Fluctuation of 24-hour intraocular pressure
Eligibility
Minimum age: 29 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Additional Information
Starting date: August 2009
Last updated: May 9, 2014
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