search
Back to results

Equivalence Study of Dorzolamide 2% Eye Drops Solution

Primary Purpose

Open Angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Dorzolamide 2 % eye drops solution
Sponsored by
Alfred E. Tiefenbacher (GmbH & Co. KG)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open Angle Glaucoma focused on measuring Equivalence Study, Eye Drops Solution, Dorzolamide, Open Angle Glaucoma, Ocular Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Opthalmology, Johannes-Gutenberg University Mainz

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dorzolamide

Arm Description

Outcomes

Primary Outcome Measures

intraocular pressure (IOP)-lowering

Secondary Outcome Measures

Full Information

First Posted
April 8, 2009
Last Updated
February 11, 2010
Sponsor
Alfred E. Tiefenbacher (GmbH & Co. KG)
search

1. Study Identification

Unique Protocol Identification Number
NCT00878917
Brief Title
Equivalence Study of Dorzolamide 2% Eye Drops Solution
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 Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Alfred E. Tiefenbacher (GmbH & Co. KG)

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Angle Glaucoma, Ocular Hypertension
Keywords
Equivalence Study, Eye Drops Solution, Dorzolamide, Open Angle Glaucoma, Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dorzolamide
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dorzolamide 2 % eye drops solution
Intervention Description
1 drop into eye(s) three times a day for the duration of each treatment phase
Primary Outcome Measure Information:
Title
intraocular pressure (IOP)-lowering
Time Frame
9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norbert Pfeiffer, Prof. Dr.
Organizational Affiliation
Department of Opthalmology, Johannes Gutenberg University Mainz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Opthalmology, Johannes-Gutenberg University Mainz
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
1711957
Citation
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.
Results Reference
background
PubMed Identifier
12751655
Citation
Distelhorst JS, Hughes GM. Open-angle glaucoma. Am Fam Physician. 2003 May 1;67(9):1937-44.
Results Reference
background
PubMed Identifier
35909461
Citation
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.
Results Reference
derived

Learn more about this trial

Equivalence Study of Dorzolamide 2% Eye Drops Solution

We'll reach out to this number within 24 hrs