NCT00878917

Equivalence Study of Dorzolamide 2% Eye Drops Solution

Randomized, Double-Masked, Active Controlled, Crossover Phase III Equivalence Study of Dorzolamide 2% Eye Drops Solution In Subjects With Open Angle Glaucoma Or Ocular Hypertension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Alfred E. Tiefenbacher (GmbH & Co. KG) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study aims to prospectively prove the equivalence of the test product and the reference solution in lowering intraocular pressure in patients with open angle glaucoma and ocular hypertension. For this purpose the patients are randomized into two sequences of study drug administration in a crossover study with an adequate wash-out period.

Conditions

• Open Angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	Dorzolamide 2 % eye drops solution	1 drop into eye(s) three times a day for the duration of each treatment phase

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2009-04-09
• Last updated: 2010-02-12

Locations

1 site across 1 country: Germany