24-hr Intraocular Pressure Control With Dorzolamide/Timolol vs the Brimonidine/Timolol Fixed Combination

Phase 4

Completed

• Conditions: Glaucoma
• Interventions: Drug: treatment with dorzolamide/timolol; Drug: treatment with brimonidine/timolol

• Registration Number: NCT00972257
• Lead Sponsor: Aristotle University Of Thessaloniki

Brief Summary

The proposed study will compare for the first time the quality of 24-hour IOP control with Brimonidine/Timolol fixed combination (BTFC) versus Dorzolamide/Timolol fixed combination (DTFC) after a run-in period of 2 months with timolol. This crossover comparison may determine the real efficacy of the two fixed combinations and the design of the proposed study may explain for the first time why the 24-hour IOP reduction provided by BTFC is less than might be anticipated.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Study First Submitted: 2009-09-03
• Study First Submitted QC: 2009-09-03
• Study First Posted: 2009-09-04
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-09
• Last Update Posted: 2014-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Consecutive, newly diagnosed or previously untreated POAG patients
• Patients with typical glaucomatous disc, or visual field damage
• Patient must have IOP (at 10:00 ± 1 hour)greater than 25 mm Hg

Exclusion Criteria

• Uncontrolled glaucoma
• Distance best corrected Snellen visual acuity worse than 1/10
• Contraindications to brimonidine or dorzolamide and β-blockers
• History of lack of response (<10% morning IOP reduction) to any medication
• Patient can not understand the instructions and adhere to medications
• Patient is a female of childbearing potential or lactating mother
• Prior surgery, past use of steroids (within 2 months)
• Severe dry eyes and use of contact lenses
• History of non-adherence
• Patients with closed angles

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Drug: Dorzolamide/Timolol	treatment with dorzolamide/timolol	-
Treatment with Brimonidine/Timolol	treatment with brimonidine/timolol	-

Primary Outcome Measures

Name	Time	Method
To compare the quality of 24-hour IOP control after 2 months of chronic therapy with the Dorzolamide/Timolol fixed combination versus the Brimonidine/Timolol fixed combination in primary open-angle glaucoma.	3 months

Secondary Outcome Measures

Name	Time	Method
Assess fluctuation of 24-hour pressure	3 months

Trial Locations

Locations (1)

Glaucoma Unit, 1st University Dept of Ophthalmology; 🇬🇷 Thessaloniki, Greece