NCT00822055

Comparison of the Fixed Combinations of Brimonidine/Timolol and Dorzolamide/Timolol in Subjects With Open-Angle Glaucoma or Ocular Hypertension

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study compares the efficacy and tolerability/comfort of brimonidine/timolol and dorzolamide/timolol in patients with open-angle glaucoma or ocular hypertension. In an investigator masked randomisation process, each subject is allocated to received either brimonidine/timolol or dorzolamide/timolol as fixed-combination monotherapy or as an adjunctive to a prostaglandin analogue for a period of 12 weeks. After screening, patient returns at baseline, Month 1 and Month 3 for ophthalmic evaluations.

Conditions

• Open-Angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination	1 drop BID in each eye
DRUG	dorzolamide hcl 2%/timolol maleate 0.5% fixed combination	1 drop BID in each eye
DRUG	brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy	1 drop BID in each eye
DRUG	dorzolamide hcl 2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy	1 drop BID in each eye

Timeline

• Start date: 2005-05-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2009-01-14
• Last updated: 2009-01-14

Locations

1 site across 1 country: Canada