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

NCT ID: NCT00972257

Last Updated: 2014-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2009-09-30

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.

Conditions

Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Drug: Dorzolamide/Timolol

Group Type: ACTIVE_COMPARATOR

treatment with dorzolamide/timolol

Intervention Type: DRUG

24-hour IOP control with the two fixed combinations

Treatment with Brimonidine/Timolol

Group Type: ACTIVE_COMPARATOR

treatment with brimonidine/timolol

Intervention Type: DRUG

24-hour pressure control with brimonidine/timolol

Interventions

treatment with dorzolamide/timolol

24-hour IOP control with the two fixed combinations

Intervention Type: DRUG

treatment with brimonidine/timolol

24-hour pressure control with brimonidine/timolol

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 29 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aristotle University Of Thessaloniki

OTHER

Sponsor Role: lead

Responsible Party

AGP Konstas

Professor in Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anastasios Konstas, MD, phD

Role: PRINCIPAL_INVESTIGATOR

Head of Glaucoma Unit

Locations

Glaucoma Unit, 1st University Dept of Ophthalmology

Thessaloniki, , Greece

Countries

Greece

References

Konstas AG, Quaranta L, Yan DB, Mikropoulos DG, Riva I, Gill NK, Barton K, Haidich AB. Twenty-four hour efficacy with the dorzolamide/timolol-fixed combination compared with the brimonidine/timolol-fixed combination in primary open-angle glaucoma. Eye (Lond). 2012 Jan;26(1):80-7. doi: 10.1038/eye.2011.239. Epub 2011 Sep 30.

Reference Type: DERIVED

PMID: 21960068 (View on PubMed)

Other Identifiers

A5132

Identifier Type: -

Identifier Source: org_study_id