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

Quality of 24-hour Intraocular Pressure Control Obtained With Dorzolamide/Timolol Fixed Combination (DTFC) Compared With the Brimonidine/Timolol Fixed Combination (BTFC) in Subjects With Primary Open-angle Glaucoma

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00972257

Enrollment

Registered

2009-09-04

Start date

2009-01-31

Completion date

2009-09-30

Last updated

2014-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

Keywords

24-hour IOP control, primary open-angle glaucoma, brimonidine/timolol, dorzolamide/timolol

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.

Interventions

DRUGtreatment with dorzolamide/timolol

24-hour IOP control with the two fixed combinations

DRUGtreatment with brimonidine/timolol

24-hour pressure control with brimonidine/timolol

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

29 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Assess fluctuation of 24-hour pressure	3 months

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026