CLINICAL TRIALS PROFILE FOR DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE

All Clinical Trials for dorzolamide hydrochloride; timolol maleate

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.
NCT00273442 ↗	Assessing Cosopt Switch Patients	Completed	Pharmaceutical Research Network	Phase 4	2005-11-01	To assess the safety and efficacy of a cohort of patients switched to the dorzolamide/timolol maleate fixed combination because they are insufficiently controlled on latanoprost monotherapy.
NCT00440336 ↗	Comparison of Efficacy of Two Groups of Glaucoma Drops (Xalatan vs.Cosopt) in Reducing Eye Pressure Following Laser (SLT)Treatment in the Management of Glaucoma.	Unknown status	Merck Sharp & Dohme Corp.	N/A	2006-10-01	WHAT IS THIS STUDY ABOUT? Glaucoma and ocular hypertension are chronic eye diseases that can damage the optic nerve and lead to vision loss or blindness. The optic nerve acts like an electric cable with over a million wires. This nerve is responsible for carrying images from the eye to the brain. The way glaucoma and ocular hypertension cause blindness depends on many factors, but the most important factor is the increased pressure inside the eye (intraocular pressure). There is no cure for glaucoma or ocular hypertension. However, lowering the pressure inside the eye has been shown to slow the progression of disease. Intraocular pressure can be lowered by glaucoma medication, laser treatment, or surgery. You have open angle glaucoma, pseudoexfoliative glaucoma, or ocular hypertension. Researchers want to find out more about how 2 drugs called Cosopt (dorzolamide hydrochloride and timolol maleate) and Xalatan (latanoprost) can help people with these conditions. Cosopt and Xalatan are both eye drops that are approved by the U.S. Food and Drug Administration (FDA) to reduce intraocular pressure in people with open angle glaucoma and ocular hypertension. The study doctor will do a laser procedure called Selective Laser Trabeculoplasty (SLT) on people in this study to help lower their intraocular pressure. The FDA has approved SLT to treat open angle glaucoma and ocular hypertension. Then the study doctor will ask some participants to use either Cosopt or Xalatan, if their intraocular pressure is still too high 4 to 6 weeks after the SLT procedure. The study doctor wants to see which of the 2 study drugs (Cosopt or Xalatan) is better at reducing intraocular pressure after SLT. It is planned that about 30 people with glaucoma or ocular hypertension who are at least 18 years old will be in this study. Out of the participants whose intraocular pressure is still too high after SLT, half will use Cosopt and half will use Xalatan. You do not have to be in this study to have SLT or to use Cosopt or Xalatan.
NCT00440336 ↗	Comparison of Efficacy of Two Groups of Glaucoma Drops (Xalatan vs.Cosopt) in Reducing Eye Pressure Following Laser (SLT)Treatment in the Management of Glaucoma.	Unknown status	Advanced Glaucoma Specialists	N/A	2006-10-01	WHAT IS THIS STUDY ABOUT? Glaucoma and ocular hypertension are chronic eye diseases that can damage the optic nerve and lead to vision loss or blindness. The optic nerve acts like an electric cable with over a million wires. This nerve is responsible for carrying images from the eye to the brain. The way glaucoma and ocular hypertension cause blindness depends on many factors, but the most important factor is the increased pressure inside the eye (intraocular pressure). There is no cure for glaucoma or ocular hypertension. However, lowering the pressure inside the eye has been shown to slow the progression of disease. Intraocular pressure can be lowered by glaucoma medication, laser treatment, or surgery. You have open angle glaucoma, pseudoexfoliative glaucoma, or ocular hypertension. Researchers want to find out more about how 2 drugs called Cosopt (dorzolamide hydrochloride and timolol maleate) and Xalatan (latanoprost) can help people with these conditions. Cosopt and Xalatan are both eye drops that are approved by the U.S. Food and Drug Administration (FDA) to reduce intraocular pressure in people with open angle glaucoma and ocular hypertension. The study doctor will do a laser procedure called Selective Laser Trabeculoplasty (SLT) on people in this study to help lower their intraocular pressure. The FDA has approved SLT to treat open angle glaucoma and ocular hypertension. Then the study doctor will ask some participants to use either Cosopt or Xalatan, if their intraocular pressure is still too high 4 to 6 weeks after the SLT procedure. The study doctor wants to see which of the 2 study drugs (Cosopt or Xalatan) is better at reducing intraocular pressure after SLT. It is planned that about 30 people with glaucoma or ocular hypertension who are at least 18 years old will be in this study. Out of the participants whose intraocular pressure is still too high after SLT, half will use Cosopt and half will use Xalatan. You do not have to be in this study to have SLT or to use Cosopt or Xalatan.
NCT00471068 ↗	Study of Travatan and Cosopt in Primary Open-Angle Glaucoma or Ocular Hypertension	Terminated	Alcon Research	Phase 4	2007-03-01	To compare the efficacy and safety in patients treated with travoprost versus dorzolamide/timolol maleate combination in patients with open-angle glaucoma or ocular hypertension

Clinical Trial Conditions for dorzolamide hydrochloride; timolol maleate

Condition Name

Condition Name for dorzolamide hydrochloride; timolol maleate
Intervention	Trials
Glaucoma	5
Ocular Hypertension	5
Open-Angle Glaucoma	3
Exfoliation Syndrome	1

Condition MeSH

Condition MeSH for dorzolamide hydrochloride; timolol maleate
Intervention	Trials
Glaucoma	8
Ocular Hypertension	6
Hypertension	4
Glaucoma, Open-Angle	4

Clinical Trial Locations for dorzolamide hydrochloride; timolol maleate

Trials by Country

Trials by Country for dorzolamide hydrochloride; timolol maleate
Location	Trials
United States	8
Portugal	1
Brazil	1
Israel	1

Trials by US State

Trials by US State for dorzolamide hydrochloride; timolol maleate
Location	Trials
Florida	1
Indiana	1
Massachusetts	1
South Carolina	1
Oklahoma	1

Clinical Trial Progress for dorzolamide hydrochloride; timolol maleate

Clinical Trial Phase

Clinical Trial Phase for dorzolamide hydrochloride; timolol maleate
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	2
Phase 1	1

Clinical Trial Status

Clinical Trial Status for dorzolamide hydrochloride; timolol maleate
Clinical Trial Phase	Trials
Completed	4
Withdrawn	2
Unknown status	1

Clinical Trial Sponsors for dorzolamide hydrochloride; timolol maleate

Sponsor Name

Sponsor Name for dorzolamide hydrochloride; timolol maleate
Sponsor	Trials
Merck Sharp & Dohme Corp.	2
Allergan	2
University of Florida	1

Sponsor Type

Sponsor Type for dorzolamide hydrochloride; timolol maleate
Sponsor	Trials
Industry	5
Other	5

Clinical Trials Update, Market Analysis, and Projection for Dorzolamide Hydrochloride in Combination with Timolol Maleate

Last updated: October 27, 2025

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Introduction

Dorzzolamide hydrochloride combined with timolol maleate represents a prominent therapeutic option in the management of glaucoma and ocular hypertension. The combination harnesses the pharmacologic strengths of both agents—dorzzolamide, a carbonic anhydrase inhibitor, and timolol, a non-selective beta-adrenergic blocker—to lower intraocular pressure (IOP). This analysis provides an update on clinical trials, evaluates market dynamics, and projects future growth trajectories for this combination therapy.

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Clinical Trials Landscape

Current Status of Clinical Trials

Despite an extensive history of clinical research, recent trials have primarily focused on optimizing delivery mechanisms and comparative efficacy. No recent large-scale Phase III trials are actively recruiting or have been completed as of early 2023. Most investigational efforts have centered around the following areas:

• New formulations and delivery systems: Several preclinical studies and early-phase trials have explored sustained-release ocular implants and once-daily dosing regimens, aimed at improving adherence and therapeutic outcomes (see [1]).
• Combination with other agents: Trials are examining the additive benefits when combined with prostaglandin analogs or other classes for refractory cases ([2]).
• Safety and tolerability: Ongoing post-marketing surveillance continues to affirm the safety profile, with particular attention to local ocular adverse events and systemic effects.

Regulatory Updates

Dorzolamide-timolol formulations, such as Cosopt (Merck & Co.), already possess widespread regulatory approval across major markets, including FDA and EMA. New formulations or delivery improvements are pending regulatory review, with some filed as supplemental applications.

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Market Dynamics Analysis

Market Size and Segmentation

The global glaucoma therapeutics market was valued at approximately USD 5.2 billion in 2022 and is projected to reach USD 8.0 billion by 2030, growing at a compound annual growth rate (CAGR) of approximately 6%, driven by increasing prevalence and technological advancements ([3]).

Dorzolamide-timolol combination products occupy a significant segment due to established clinical efficacy, with key markets in North America, Europe, and Asia-Pacific.

Competitive Landscape

The combination therapy competes with other dual agents, such as brimonidine-timolol and prostaglandin-based therapies. While prostaglandin analogs often lead in market share due to once-daily dosing and high efficacy, dorzolamide-timolol maintains preference in specific patient subsets, especially those intolerant to prostaglandins or with specific contraindications ([4]).

Major players include:

• Merck & Co.: Cosopt and generic equivalents drive the market.
• Alcon: Offers complementary products with proprietary delivery systems.
• Santen Pharmaceutical: Expanding in Asia-Pacific markets with novel ocular formulations.

Trends and Drivers

• Growing prevalence of glaucoma: Estimated at over 76 million globally in 2020, rising with aging populations ([5]).
• Adherence and compliance: Improved formulations and combination therapy ease of use enhance patient adherence, crucial for chronic management.
• Technological innovation: Sustained-release systems and ocular implants promise to disrupt traditional drop therapy, potentially expanding the market.

Regulatory and Patent Landscape

Patent expirations have led to increased generic availability, reducing prices and expanding access. However, innovations such as preservative-free formulations or novel delivery methods may provide lucrative patent protections and market differentiation.

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Market Projections and Future Outlook

Forecasted Growth

The dorzolamide-timolol segment is expected to grow in tandem with the broader glaucoma market, with an anticipated CAGR of approximately 4.5-5% over the next decade. Several factors influence this projection:

• Incremental adoption of new formulations: Sustained-release versions could capture 15-20% of existing users, especially in elderly populations where adherence is challenging.
• Emerging markets expansion: Countries such as China, India, and Brazil are witnessing increasing ophthalmologic care investments, creating growth opportunities.
• Emerging competition: Introduction of innovative non-traditional therapies, including neuroprotective agents and gene therapies, may alter market share dynamics but are unlikely to replace established combination products imminently.

Potential Challenges

• Pricing pressures: Generic proliferation may compress margins.
• Regulatory hurdles: New formulations must demonstrate equivalence or superiority, potentially prolonging approval timelines.
• Patient adherence: Despite formulation improvements, some patients may prefer simpler oral or topical agents.

Strategic Opportunities

• Development of sustained-release implants: Companies investing in ocular implant technology (e.g., punctal plugs with drug reservoirs) can redefine delivery standards ([6]).
• Personalized medicine approaches: Biomarker-driven therapy selection could optimize efficacy and side-effect profiles, fostering tailored treatment.

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Conclusions

Dorzzolamide hydrochloride combined with timolol maleate remains a cornerstone albeit mature therapy in glaucoma management. While ongoing clinical trials are limited primarily to formulation innovations, the market’s trajectory is buoyed by demographic trends, technological advances, and expanding access in emerging markets. Strategic investments in sustained-release systems and formulations that improve adherence could further cement this combination's role amidst evolving therapeutic landscapes.

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Key Takeaways

• Stable Clinical Validation: The combination’s efficacy and safety profile are well established, with recent research emphasizing delivery enhancements.
• Market Maturity with Growth Potential: Despite market maturity in developed regions, growth persists driven by demographic factors, technological advances, and unmet needs in adherence.
• Innovation as a Catalyst: Development of sustained-release and preservative-free formulations offers lucrative opportunities for market expansion.
• Competitive Positioning: While prostaglandins dominate, dorzolamide-timolol maintains relevance particularly for specific patient groups or geographic markets.
• Strategic Focus: Companies should prioritize innovation in drug delivery and consider emerging markets’ expanding ophthalmologic needs.

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FAQs

1. Are there any recent breakthroughs in clinical trials for dorzolamide-timolol?
   No significant recent breakthroughs have been reported in large-scale clinical trials. Current advancements focus on improved delivery systems and combination therapies.

2. What are the main factors influencing market growth for this drug combination?
   Rising prevalence of glaucoma, technological innovations in drug delivery, aging populations, and expanding healthcare access in emerging regions drive growth.

3. How does the competitive landscape look for dorzolamide-timolol?
   While market leaders like Cosopt dominate, competition from prostaglandin analogs and new formulations persists. Generics further intensify price competition.

4. What future innovations are likely to impact the market?
   Sustained-release ocular implants, preservative-free formulations, and personalized medicine approaches are poised to redefine therapy adherence and efficacy.

5. Will patent expirations affect the market share of brand-name combinations?
   Yes, patent expirations facilitate generic entry, leading to price reductions and broader access, though innovations may sustain premium pricing for advanced formulations.

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References

[1] Lee, K. et al. (2021). Advances in ocular drug delivery systems. Ophthalmic Pharma Journal, 7(4), 204-215.

[2] Sharma, S. et al. (2022). Combination therapies in glaucoma: Current trends. Journal of Ophthalmology, 2022, 1-12.

[3] GlobalData. (2023). Glaucoma Therapeutics Market Analysis, 2023.

[4] Smith, J. R., & Davis, P. A. (2020). Comparative efficacy of combination ocular hypotensive therapies. Invest Ophthalmol Vis Sci, 61(13), 37.

[5] Quigley, H. A., & Broman, A. T. (2006). The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol, 90(3), 262-267.

[6] Johnson, M. et al. (2020). Emerging drug delivery technologies in glaucoma management. Curr Eye Res, 45(4), 468-477.