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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00972257
• Other study ID #: A5132
• Status: Completed
• Phase: Phase 4
• First received: September 3, 2009
• Last updated: May 9, 2014
• Start date: January 2009
• Est. completion date: September 2009

Study information

• Verified date: May 2014
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 29 Years to 80 Years

Eligibility

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 ß-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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

Drug:
• treatment with dorzolamide/timolol
24-hour IOP control with the two fixed combinations
• treatment with brimonidine/timolol
24-hour pressure control with brimonidine/timolol

Locations

Country	Name	City	State
Greece	Glaucoma Unit, 1st University Dept of Ophthalmology	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Assess fluctuation of 24-hour pressure		3 months	No