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Equivalence Study of Dorzolamide 2% Eye Drops Solution

This study has been completed.
Sponsor:
Information provided by:
Alfred E. Tiefenbacher (GmbH & Co. KG)
ClinicalTrials.gov Identifier:
NCT00878917
First received: April 8, 2009
Last updated: February 11, 2010
Last verified: February 2010
History of Changes
  Purpose

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 Intervention Phase
Open Angle Glaucoma
Ocular Hypertension
 Drug: Dorzolamide 2 % eye drops solution
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Single Blind (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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alfred E. Tiefenbacher (GmbH & Co. KG):

Primary Outcome Measures:
  • intraocular pressure (IOP)-lowering [ Time Frame: 9 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 32
Study Start Date: April 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dorzolamide Drug: Dorzolamide 2 % eye drops solution
1 drop into eye(s) three times a day for the duration of each treatment phase

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00878917

Locations
Germany
Department of Opthalmology, Johannes-Gutenberg University Mainz
Mainz, Rheinland-Pfalz, Germany, 55131
Sponsors and Collaborators
Alfred E. Tiefenbacher (GmbH & Co. KG)
Investigators
Principal Investigator: Norbert Pfeiffer, Prof. Dr. Department of Opthalmology, Johannes Gutenberg University Mainz
  More Information

Publications:

Responsible Party: Dr. Harm Peters, Alfred E. Tiefenbacher (GmbH & Co. KG)
ClinicalTrials.gov Identifier: NCT00878917     History of Changes
Other Study ID Numbers: DOR/2008
Study First Received: April 8, 2009
Last Updated: February 11, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Alfred E. Tiefenbacher (GmbH & Co. KG):
Equivalence Study
Eye Drops Solution
Dorzolamide
Open Angle Glaucoma
Ocular Hypertension

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Tetrahydrozoline
Dorzolamide
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
 Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013