Equivalence Study of Dorzolamide 2% Eye Drops Solution

Sponsor

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

Overall Status

Completed

CT.gov ID

NCT00878917

Collaborator

(none)

Enrollment

Location

Arm

10.1

Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Open Angle Glaucoma Ocular Hypertension	Drug: Dorzolamide 2 % eye drops solution	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2009

Actual Primary Completion Date :

Feb 1, 2010

Actual Study Completion Date :

Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dorzolamide	Drug: Dorzolamide 2 % eye drops solution 1 drop into eye(s) three times a day for the duration of each treatment phase

Arm

Intervention/Treatment

Experimental: Dorzolamide

Drug: Dorzolamide 2 % eye drops solution

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

Outcome Measures

Primary Outcome Measures

intraocular pressure (IOP)-lowering [9 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female patients of any race aged 18 years or older
A clinical diagnosis of open angle glaucoma, pseudoexfoliation or pigment dispersion glaucoma, or ocular hypertension in one or both eyes
IOP controllable on one drug treatment in the study eye in way that assures clinical stability of vision and the optic nerve throughout the study
Baseline IOP between 18 and 32 mmHg in the study eye (in eyes not included in the study IOP must have been controllable on no pharmacologic treatment or on the study medicine only)
Best corrected visual acuity of 20/200 or better in the study eye(s)
Ability of subject to understand character and individual consequences of clinical trial
Signed and dated informed consent of the subject must be available before start of any specific trial procedures
Women with childbearing potential have to practicing a medically accepted contraception during trial and a negative pregnancy test (serum or urine) should be existent before trial. Reliable contraception are systemic contraceptives (oral, implant, injection) and diaphragm or condoms with spermicidal. Women that are sterile by surgery or for more than two years postmenopausal can be participate in the trial.

Exclusion Criteria:

Chronic or recurrent inflammatory eye disease
Ocular trauma within the past six months
Current ocular infection, i.e. conjunctivitis or keratitis
Any abnormality preventing reliable applanation tonometry
Intraocular surgery or laser treatment within the past three months
Inability to discontinue contact lens wear during the study
Use of any systemic medication that would affect IOP with less than a

1-month stable dosing regimen before the screening visit

Pregnancy and lactation
History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product
Participation in other clinical trials during the present clinical trial or within the last four weeks
Medical or psychological condition that would not permit completion of the trial or signing of informed consent
Subject is allergic to sulfonamides
Severe renal dysfunction or hyperchloraemic acidosis