Equivalence Study of Dorzolamide 2% Eye Drops Solution

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.

Timeline

Start

2009-04

Primary completion

2010-02

Completion

2010-02

Outcome

Met primary endpoint

paper the 90% confidence interval for the average change of the IOP -0.27 mmHg (-1.17 mmHg-0.64 mmHg) is included by the acceptance range -1.5 mmHg to +1.5 mmHg PMID 35909461 ↗

Publications

• Background Hurvitz LM, Kaufman PL, Robin AL, Weinreb RN, Crawford K, Shaw B. New developments in the drug treatment of glaucoma. Drugs. 1991 Apr;41(4):514-32. doi: 10.2165/00003495-199141040-00002.
• Background Distelhorst JS, Hughes GM. Open-angle glaucoma. Am Fam Physician. 2003 May 1;67(9):1937-44.
• Bell K, Korb C, Butsch C, Giers BC, Beck A, Strzalkowska A, Ruckes C, Klingberg U, Pfeiffer N, Lorenz K. A Randomized, Double-Masked, Active-Controlled, Crossover Phase III Equivalence Study of Generic Dorzolamide 2% versus Innovator Trusopt(R) Eye Drop Solution in Subjects with Open-Angle Glaucoma or Ocular Hypertension. J Ophthalmol. 2022 Jul 20;2022:5249922. doi: 10.1155/2022/5249922. eCollection 2022.

Drugs

Indications