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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dorzolamide | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dorzolamide 2 % eye drops solution | Drug | 1 drop into eye(s) three times a day for the duration of each treatment phase |
|
| Measure | Description | Time Frame |
|---|---|---|
| intraocular pressure (IOP)-lowering | 9 weeks |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Norbert Pfeiffer, Prof. Dr. | Department of Opthalmology, Johannes Gutenberg University Mainz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Opthalmology, Johannes-Gutenberg University Mainz | Mainz | Rhineland-Palatinate | 55131 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1711957 | 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. | |
| 12751655 | Background | Distelhorst JS, Hughes GM. Open-angle glaucoma. Am Fam Physician. 2003 May 1;67(9):1937-44. |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C062765 | dorzolamide |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
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| 35909461 | Derived | 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. |
| D020228 |
| Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |