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Last Updated: February 29, 2024

CLINICAL TRIALS PROFILE FOR DORZOLAMIDE HYDROCHLORIDE


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505(b)(2) Clinical Trials for Dorzolamide Hydrochloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT05857267 ↗ Dorzolamide+Timolol Multidose Preservative-free vs Dorzolamida+Timolol BAK Preserved Efficacy and Safety Recruiting Laboratorios Poen Phase 4 2023-03-07 The goal of this study is to evaluate the tolerability of the new formulation of Dorzolamide+Timolol preservative free developed in OSD Aptar Pharma multidose system in comparison with Dorzolamide +Timolol BAK preserved ophthalmic formulation.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Dorzolamide Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00108017 ↗ Comparison of the Effects of Two Glaucoma Drugs Over 24 Hours (0507A-137)(COMPLETED) Completed Merck Sharp & Dohme Corp. Phase 3 2005-04-01 This study is comparing 2 medications for glaucoma and how effective they are at controlling glaucoma over the course of an entire day.
NCT00140049 ↗ A 12week, Randomized, Evaluator-Masked, Parallel Group Comparing Evening Dosing Of Xalacom Vs Cosopt In Subj W/ Glaucoma Completed Pfizer Phase 4 2005-07-01 To demonstrate the statistical non inferiority of the combination of latanoprost and timolol given in the evening time once a day vs the combination of dorzamalide and timolol twice a day based on intraocular pressure measurements at 8 AM, 12 noon & 4 PM during a 12 week treatment.
NCT00140049 ↗ A 12week, Randomized, Evaluator-Masked, Parallel Group Comparing Evening Dosing Of Xalacom Vs Cosopt In Subj W/ Glaucoma Completed Pfizer's Upjohn has merged with Mylan to form Viatris Inc. Phase 4 2005-07-01 To demonstrate the statistical non inferiority of the combination of latanoprost and timolol given in the evening time once a day vs the combination of dorzamalide and timolol twice a day based on intraocular pressure measurements at 8 AM, 12 noon & 4 PM during a 12 week treatment.
NCT00152932 ↗ Ocular Blood Flow in Early Glaucoma Patients Before and After Treatment With Dorzolamide Unknown status Merck Frosst Canada Ltd. N/A 2005-05-01 Impaired ocular blood flow is an important risk factor in the pathogenesis of primary open angle glaucoma (POAG). A few studies suggest that topical dorzolamide 2% may increase optic nerve perfusion. The objectives of this study are to learn the effects of dorzolamide on the retinal and optic nerve blood flow of glaucoma patients. The present study is a prospective, randomized, double-masked, crossover design study of newly diagnosed or already treated patients with early glaucoma. The investigators will check ocular blood flow parameters using the Canon Laser Blood Flowmeter (CLBF), used to evaluate retinal arteriole blood flow, and the Heidelberg retinal flowmeter (HRF), which measures blood flow through capillary beds in the retina and optic nerve head. Any demonstrated improvements to retinal and optic nerve blood flow with dorzolamide, will mean that the drug may protect against ischaemic nerve and retinal damage. Any documented improvement in flow could lead to a major change in the management of glaucoma patients as well as other retinal ischemic diseases such as diabetic retinopathy and central retinal vein occlusion.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Dorzolamide Hydrochloride

Condition Name

Condition Name for Dorzolamide Hydrochloride
Intervention Trials
Ocular Hypertension 23
Glaucoma 21
Open-Angle Glaucoma 9
Open Angle Glaucoma 4
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Condition MeSH

Condition MeSH for Dorzolamide Hydrochloride
Intervention Trials
Glaucoma 41
Ocular Hypertension 25
Glaucoma, Open-Angle 22
Hypertension 19
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Clinical Trial Locations for Dorzolamide Hydrochloride

Trials by Country

Trials by Country for Dorzolamide Hydrochloride
Location Trials
United States 31
Greece 5
Italy 4
Canada 3
Mexico 3
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Trials by US State

Trials by US State for Dorzolamide Hydrochloride
Location Trials
Pennsylvania 5
Illinois 4
Texas 3
Florida 3
New York 2
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Clinical Trial Progress for Dorzolamide Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Dorzolamide Hydrochloride
Clinical Trial Phase Trials
Phase 4 24
Phase 3 10
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Dorzolamide Hydrochloride
Clinical Trial Phase Trials
Completed 38
Unknown status 7
Recruiting 3
[disabled in preview] 2
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Clinical Trial Sponsors for Dorzolamide Hydrochloride

Sponsor Name

Sponsor Name for Dorzolamide Hydrochloride
Sponsor Trials
Merck Sharp & Dohme Corp. 6
Allergan 4
Laboratorios Sophia S.A de C.V. 3
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Sponsor Type

Sponsor Type for Dorzolamide Hydrochloride
Sponsor Trials
Other 43
Industry 27
NIH 2
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