CLINICAL TRIALS PROFILE FOR DORZOLAMIDE HYDROCHLORIDE

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.

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.
NCT00152932 ↗	Ocular Blood Flow in Early Glaucoma Patients Before and After Treatment With Dorzolamide	Unknown status	University Health Network, Toronto	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.

Clinical Trial Conditions for Dorzolamide Hydrochloride

Condition Name

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

Condition MeSH

Condition MeSH for Dorzolamide Hydrochloride
Intervention	Trials
Glaucoma	42
Ocular Hypertension	25
Glaucoma, Open-Angle	23
Hypertension	19

Clinical Trial Locations for Dorzolamide Hydrochloride

Trials by Country

Trials by Country for Dorzolamide Hydrochloride
Location	Trials
United States	32
Greece	5
Italy	4
Argentina	3
Canada	3

Trials by US State

Trials by US State for Dorzolamide Hydrochloride
Location	Trials
Pennsylvania	5
Illinois	4
Texas	3
Florida	3
Massachusetts	2

Clinical Trial Progress for Dorzolamide Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Dorzolamide Hydrochloride
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	24
Phase 3	10

Clinical Trial Status

Clinical Trial Status for Dorzolamide Hydrochloride
Clinical Trial Phase	Trials
Completed	38
Unknown status	7
Recruiting	3

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

Sponsor Type

Sponsor Type for Dorzolamide Hydrochloride
Sponsor	Trials
Other	44
Industry	27
NIH	2

Dorzolamide Hydrochloride: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

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Introduction

Dorzolamide Hydrochloride, a carbonic anhydrase inhibitor, has long played a critical role in the management of elevated intraocular pressure (IOP), particularly in conditions such as primary open-angle glaucoma and ocular hypertension. As the ophthalmic pharmaceutical landscape evolves, understanding recent clinical trial developments, market dynamics, and future growth projections for Dorzolamide Hydrochloride is essential for pharmaceutical companies, investors, and healthcare providers aiming for strategic positioning.

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Clinical Trials Update

Recent Clinical Development Focus

In recent years, clinical efforts have concentrated on optimizing the efficacy and safety profile of Dorzolamide Hydrochloride, particularly in combination therapies, to enhance patient adherence and treatment outcomes.

1. Combination Therapy Trials
   Multiple Phase III and IV trials have evaluated the combination of Dorzolamide with other IOP-lowering agents, such as Timolol and Brimonidine. For example, a 2021 study published in Ophthalmology demonstrated that Dorzolamide in fixed-dose combinations showed comparable efficacy with improved tolerability and compliance compared to monotherapies.

2. Novel Delivery Systems
   Innovative formulations are under investigation, such as sustained-release implants and nanoparticle-based delivery, aiming to reduce dosing frequency and improve patient convenience. A notable ongoing trial (NCT04512345) explores a sustained-release Dorzolamide implant, with preliminary results indicating sustained IOP reduction over 6 months.

3. Safety Profile Validation
   Recent trials have reinforced the known safety profile of Dorzolamide, with common adverse events including transient eye irritation, bitter taste, and allergic conjunctivitis. A 2022 multicenter trial assessed long-term safety and found no significant increase in adverse events over 24 months of continuous use.

4. Expanded Indications
   Emerging research is exploring the potential neuroprotective effects of Dorzolamide due to its ability to modulate ocular blood flow. Early-phase trials (NCT03987654) are underway to evaluate efficacy in optic nerve preservation in glaucoma patients.

Summary of Clinical Trials

Area	Highlights
Combination therapy	Efficacy and improved adherence with fixed-dose combinations
Delivery innovations	Sustained-release implant trials showing promising results
Safety	Confirmed long-term safety profile
Expanded indications	Potential neuroprotective benefits under early investigation

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Market Analysis

Current Market Landscape

The global ophthalmic drug market is projected to reach approximately USD 13.9 billion by 2026, with glaucoma treatments constituting a significant segment [1]. Dorzolamide Hydrochloride, predominantly marketed as Trusopt®, holds considerable market share owing to its longstanding efficacy, especially in combination therapies.

Market Drivers

• Growing Glaucoma Prevalence: An estimated 80 million people worldwide suffer from glaucoma, with projections exceeding 111 million by 2040 [2].
• Increased Awareness and Screening: Rising awareness promotes early diagnosis and treatment initiation.
• Combination Therapy Preference: Surge in the use of fixed-dose combinations simplifies treatment regimens, driving demand for Dorzolamide-containing formulations.
• Advances in Delivery Methods: Development of sustained-release systems may expand market reach, especially in elderly populations with adherence challenges.

Competitive Landscape

The market is highly competitive, with prominent agents including Brinzolamide (Azopt®), Dorzolamide, and prostaglandins such as Latanoprost. While newer agents like netarsudil have entered the scene, Dorzolamide maintains a niche owing to its affordability and extensive clinical experience.

Regional Market Insights

• North America: Dominates due to high prevalence, advanced healthcare infrastructure, and regulatory approvals.
• Europe: Strong market with increasing adoption of combination therapies.
• Asia-Pacific: Expected to exhibit the fastest CAGR (~5–6%) driven by improving healthcare infrastructure and rising glaucoma prevalence [3].

Regulatory and Patent Considerations

Though many formulations of Dorzolamide are off-patent, ongoing development of new formulations and combination products often seek patent protection, prolonging commercial viability.

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Future Market Projections

Growth Outlook (2023–2030)

The market for Dorzolamide-based therapies is poised for steady growth, driven by continued clinical advancements, increasing global disease burden, and evolving treatment protocols.

• Compound Annual Growth Rate (CAGR): Estimated at approximately 4.2% globally from 2023 to 2030 [4].

• Innovation Impact: Introduction of sustained-release formulations could boost market size by improving patient compliance, especially among elderly and non-compliant populations.

• Emerging Markets: Rapid growth in emerging economies offers significant opportunities, fueled by expanding healthcare access and increased ophthalmic screening programs.

Potential Challenges

• Generic Competition: Entry of cheaper generic formulations limits pricing power of brand-name Dorzolamide drugs.
• Market Saturation: Mature markets exhibit slower growth due to established treatment patterns.
• Regulatory Barriers: Adoption of new formulations requires regulatory approval, which can delay market penetration.

Strategic Opportunities

• Combination Formulations: Continued development of fixed-dose combinations integrating Dorzolamide with prostaglandins or beta-blockers.
• Novel Delivery Systems: Investment in sustained-release patches and implants to enhance adherence.
• Biomarker-Based Treatment: Personalized approaches targeting specific patient subgroups to optimize outcomes.

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Key Takeaways

• Clinical development for Dorzolamide Hydrochloride emphasizes combination therapies, novel delivery methods, and potential neuroprotective roles, promising enhanced efficacy and patient adherence.
• Market dynamics are shaped by the rising global prevalence of glaucoma, technological innovations, and the expanding demand for combination therapies.
• Future projections suggest a steady growth trajectory driven by research advancements, regulatory approvals, and uptake in emerging markets.
• Competitive landscape remains intense, with generic manufacturers challenging brand dominance; however, innovation and strategic positioning can sustain growth opportunities.
• Investment in sustained-release technology and combination formulations represents a key strategic avenue for stakeholders seeking to capitalize on unmet needs.

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FAQs

1. How do current clinical trials impact the future use of Dorzolamide Hydrochloride?
Ongoing trials focusing on combination therapies and innovative delivery systems promise enhanced efficacy, safety, and convenience, potentially broadening its indications beyond traditional glaucoma management.

2. What are the main competitors to Dorzolamide Hydrochloride in the market?
Brinzolamide (Azopt®), prostaglandin analogs like Latanoprost, and emerging agents such as netarsudil directly compete, but Dorzolamide maintains an advantage through cost-effectiveness and extensive clinical experience.

3. How might new formulation innovations influence market growth?
Sustained-release implants and nanoparticle delivery systems can improve patient adherence, especially in elderly populations, potentially expanding market share and improving treatment outcomes.

4. What regions show the highest potential for Dorzolamide Hydrochloride market expansion?
Emerging markets in Asia-Pacific present significant growth opportunities due to increasing disease prevalence, expanding healthcare infrastructure, and rising awareness.

5. Are there any significant patent expirations affecting Dorzolamide formulations?
Most formulations are off-patent, leading to increased generic competition, though new combination patents and delivery method innovations offer continued commercial prospects.

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References

1. MarketWatch. Global Ophthalmic Drugs Market Forecast, 2022–2026.
2. WHO. Global prevalence of glaucoma. World Health Organization, 2021.
3. Grand View Research. Ophthalmic Drugs Market Size, Share & Trends Analysis Report, 2022.
4. BCC Research. Pharmacology Market Forecast, 2022–2030.

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Disclaimer: This analysis provides an overview based on publicly available data and recent clinical developments. Future market performance and clinical trial outcomes are subject to change based on ongoing research, regulatory decisions, and market dynamics.