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Equivalence Study of Dorzolamide 2% Eye Drops Solution

NCT00878917 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2010-02-12

No results posted yet for this study

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

Interventions

DRUG

Dorzolamide 2 % eye drops solution

1 drop into eye(s) three times a day for the duration of each treatment phase

Sponsors & Collaborators

  • Alfred E. Tiefenbacher (GmbH & Co. KG)

    lead INDUSTRY

Principal Investigators

  • Norbert Pfeiffer, Prof. Dr. · Department of Opthalmology, Johannes Gutenberg University Mainz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00878917 on ClinicalTrials.gov