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Last Updated: February 10, 2025

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
Florida 3
Texas 3
South Carolina 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
Alcon Research 3
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Sponsor Type

Sponsor Type for Dorzolamide Hydrochloride
Sponsor Trials
Other 43
Industry 27
NIH 2
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Dorzolamide Hydrochloride: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction to Dorzolamide Hydrochloride

Dorzolamide hydrochloride is a small molecule drug developed by Merck & Co., Inc., primarily used for the treatment of glaucoma, open-angle glaucoma, and ocular hypertension. It works by inhibiting carbonic anhydrases (CAs), enzymes involved in the production of aqueous humor in the eye, thereby reducing intraocular pressure (IOP) and preventing optic nerve damage[3].

Clinical Trials and Efficacy

Early Clinical Studies

Before its approval in 1994, dorzolamide hydrochloride underwent several clinical studies to evaluate its efficacy and safety. These studies demonstrated a significant decrease in IOP when administered 2-3 times a day, either as monotherapy or in combination with other topical antiglaucoma drugs. The drug was well tolerated, with no clinically significant changes in ocular or systemic safety parameters[1][3].

Recent Clinical Data

In a randomized, placebo-controlled, double-masked study involving 20 patients with cornea guttata and 8 healthy control subjects, dorzolamide hydrochloride showed a slight but statistically significant thickening of central corneal thickness within 24 hours of treatment. This study used partial coherence interferometry to measure central corneal thickness[1].

Long-Term Efficacy

In a one-year controlled trial, dorzolamide hydrochloride ophthalmic solution 2% was compared with betaxolol 0.5% and timolol 0.5%. The results showed that dorzolamide hydrochloride maintained its efficacy in reducing IOP over the course of the year. Additionally, when added to patients already on timolol or betaxolol, dorzolamide hydrochloride further reduced IOP by 13-19%[4].

Safety and Tolerability

Pediatric and Geriatric Use

The safety and effectiveness of dorzolamide hydrochloride in children under 18 years have not been established. For geriatric patients, the drug has been used in clinical studies without significant adverse effects[4].

Lactation and Pregnancy

In lactating rats, dorzolamide hydrochloride caused decreases in body weight gain and slight delays in postnatal development in offspring. Therefore, a decision should be made whether to discontinue nursing or the drug, considering its importance to the mother[4].

Market Analysis

Current Market Size

The global market for dorzolamide hydrochloride was estimated to be worth US$ 536 million in 2023. This market is forecasted to grow to US$ 782.1 million by 2030, with a compound annual growth rate (CAGR) of 5.6% during the forecast period of 2024-2030[2][5].

Key Players

The market is dominated by several key players, including Alembic Pharms, Bausch and Lomb, FDC, Hi Tech Pharma, Micro Labs, Novartis, Merck, and Purdue Pharma. These companies play a significant role in the production, distribution, and marketing of dorzolamide hydrochloride[2][5].

Regional Analysis

The market is segmented into major regions such as North America, Europe, Asia Pacific, Middle East & Africa, and Latin America. Each region provides a unique set of market dynamics, with varying demand and growth rates. The report includes detailed insights into these regional markets, helping to understand the global distribution and consumption patterns of dorzolamide hydrochloride[5].

Market Projections

Forecast Period

The forecast period for the dorzolamide hydrochloride market extends from 2024 to 2030. During this period, the market is expected to grow significantly, driven by increasing prevalence of glaucoma and ocular hypertension, as well as advancements in ophthalmic care[2][5].

Growth Drivers

The growth of the dorzolamide hydrochloride market is driven by several factors, including the rising incidence of glaucoma, an aging population, and the need for effective and safe treatments for ocular hypertension. Additionally, the convenience of topical administration and the drug's efficacy in reducing IOP contribute to its market growth[3][5].

Market Trends

The market trends include a shift towards combination therapies, where dorzolamide hydrochloride is used in conjunction with other antiglaucoma medications to achieve better IOP control. There is also an increasing focus on patient compliance and the development of more convenient dosing regimens[4][5].

Competitive Landscape

Competitor Analysis

The competitive landscape of the dorzolamide hydrochloride market is characterized by the presence of several pharmaceutical companies. These companies compete based on factors such as product efficacy, safety profile, pricing, and market reach. The report provides a detailed competitor analysis, highlighting the strengths and weaknesses of each key player[2][5].

Technological and R&D Trends

The R&D in dorzolamide hydrochloride is focused on improving its formulation and delivery systems. There is ongoing research into new combinations and formulations that can enhance patient compliance and treatment outcomes. The highest R&D phase of this drug has been approved, and it continues to be a well-established medication in the market[3].

Key Takeaways

  • Efficacy and Safety: Dorzolamide hydrochloride is effective in reducing IOP and is generally well tolerated.
  • Market Growth: The global market is projected to grow from US$ 536 million in 2023 to US$ 782.1 million by 2030.
  • Key Players: Major pharmaceutical companies such as Merck, Novartis, and Bausch and Lomb dominate the market.
  • Regional Analysis: The market is segmented into various regions, each with unique market dynamics.
  • Growth Drivers: Increasing prevalence of glaucoma, an aging population, and the need for effective treatments drive market growth.

FAQs

Q: What is the primary use of dorzolamide hydrochloride?

A: Dorzolamide hydrochloride is primarily used for the treatment of glaucoma, open-angle glaucoma, and ocular hypertension by reducing intraocular pressure.

Q: How does dorzolamide hydrochloride work?

A: It works by inhibiting carbonic anhydrases (CAs), enzymes involved in the production of aqueous humor in the eye, thereby reducing IOP.

Q: What is the forecasted market size of dorzolamide hydrochloride by 2030?

A: The global market for dorzolamide hydrochloride is forecasted to reach US$ 782.1 million by 2030.

Q: Which companies are the key players in the dorzolamide hydrochloride market?

A: Key players include Alembic Pharms, Bausch and Lomb, FDC, Hi Tech Pharma, Micro Labs, Novartis, Merck, and Purdue Pharma.

Q: Is dorzolamide hydrochloride safe for use in children and geriatric patients?

A: The safety and effectiveness of dorzolamide hydrochloride in children under 18 years have not been established. For geriatric patients, the drug has been used in clinical studies without significant adverse effects.

Sources

  1. JAMA Ophthalmology: "Short-term Effect of Dorzolamide Hydrochloride on Central Corneal Thickness in Patients With Cornea Guttata"[1].
  2. Valuates Reports: "Dorzolamide Hydrochloride - Market, Report Size, Worth, Revenue"[2].
  3. Synapse Patsnap: "Dorzolamide Hydrochloride Unveiled: A Detailed Overview of its Revolutionary R&D Breakthroughs"[3].
  4. Health Canada: "Dorzolamide Hydrochloride Ophthalmic Solution"[4].
  5. Cognitive Market Research: "Global Dorzolamide Hydrochloride Market Report 2024 Edition"[5].

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