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

Aristotle University Of Thessaloniki64 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Glaucoma

Interventions

treatment with dorzolamide/timololDRUG

24-hour IOP control with the two fixed combinations

treatment with brimonidine/timololDRUG

24-hour pressure control with brimonidine/timolol

Eligibility

Sex: ALLMin age: 29 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Glaucoma Unit, 1st University Dept of Ophthalmology

Thessaloniki, Greece

Outcomes

Primary Outcomes

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.

Time frame: 3 months

Secondary Outcomes

Assess fluctuation of 24-hour pressure

Time frame: 3 months

Data from ClinicalTrials.gov

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