CLINICAL TRIALS PROFILE FOR TRUSOPT

All Clinical Trials for TRUSOPT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00348400 ↗	Brimonidine Purite 0.15% Versus Dorzolamide 2% Used as Adjunctive Therapy to Latanoprost	Completed	Innovative Medical	Phase 4	1969-12-31	Evaluate the relative efficacy and tolerability of Alphagan P compared to Trusopt as adjunctive therapy
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.
NCT00572936 ↗	Circadian Rhythms of Aqueous Humor Dynamics in Humans	Completed	Pfizer	Phase 2	2005-11-01	This study is designed to identify physiological, pharmacological and pathological circadian fluctuations in aqueous humor inflow and outflow, systemic blood pressure and ocular blood flow in humans.
NCT00572936 ↗	Circadian Rhythms of Aqueous Humor Dynamics in Humans	Completed	University of Nebraska	Phase 2	2005-11-01	This study is designed to identify physiological, pharmacological and pathological circadian fluctuations in aqueous humor inflow and outflow, systemic blood pressure and ocular blood flow in humans.

Clinical Trial Conditions for TRUSOPT

Condition Name

Condition Name for TRUSOPT
Intervention	Trials
Glaucoma	5
Primary Open Angle Glaucoma	2
Ocular Hypertension	2
Retinal Degenerations	1

Condition MeSH

Condition MeSH for TRUSOPT
Intervention	Trials
Glaucoma	9
Glaucoma, Open-Angle	4
Ocular Hypertension	2
Hypertension	2

Clinical Trial Locations for TRUSOPT

Trials by Country

Trials by Country for TRUSOPT
Location	Trials
United States	8
Israel	1
Denmark	1
Brazil	1
Canada	1

Trials by US State

Trials by US State for TRUSOPT
Location	Trials
Illinois	2
Florida	1
Maryland	1
Indiana	1
Nebraska	1

Clinical Trial Progress for TRUSOPT

Clinical Trial Phase

Clinical Trial Phase for TRUSOPT
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for TRUSOPT
Clinical Trial Phase	Trials
Completed	7
Unknown status	2
Active, not recruiting	1

Clinical Trial Sponsors for TRUSOPT

Sponsor Name

Sponsor Name for TRUSOPT
Sponsor	Trials
National Eye Institute (NEI)	2
Advanced Glaucoma Specialists	1
University of Sao Paulo General Hospital	1

Sponsor Type

Sponsor Type for TRUSOPT
Sponsor	Trials
Other	11
Industry	4
NIH	2

Clinical Trials Update, Market Analysis, and Projection for Trusopt

Last updated: October 28, 2025

Introduction

Trusopt (dorzolamide hydrochloride) is a carbonic anhydrase inhibitor primarily prescribed for reducing elevated intraocular pressure (IOP) in glaucoma or ocular hypertension patients. As a well-established topical ocular medication, Trusopt has maintained a significant presence in ophthalmology. This report provides a comprehensive overview of recent clinical trials, market dynamics, and future projections, equipping stakeholders with actionable insights into its evolving landscape.

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Clinical Trials Update

Recent Clinical Developments

In recent years, the development and evaluation of Trusopt have primarily concentrated on optimizing its efficacy, safety profile, and exploring new indications. Key clinical trials include:

• Combination Therapy Studies: Multiple Phase III trials assessed the efficacy of dorzolamide in combination with other IOP-lowering agents, particularly prostaglandin analogs. Results demonstrated enhanced IOP reduction compared to monotherapies, indicating therapeutic value in combination regimens for resistant glaucoma cases [1].

• Extended Use and Tolerability: Long-term open-label studies, some extending beyond 12 months, reaffirmed the safety profile of Trusopt, with minimal systemic absorption and low incidence of adverse effects such as ocular discomfort, hyperemia, or allergic reactions [2].

• Novel Delivery Systems: Experimental trials investigated sustained-release ocular implants employing dorzolamide, aiming to improve patient compliance and reduce dosing frequency. Early-phase studies show promising pharmacokinetic profiles, though these are not yet market-ready [3].

• New Indications: While primarily used for glaucoma, recent trials explored its role in reducing intraocular inflammation post-surgery, with preliminary data noting reduced postoperative pressure spikes. However, these studies remain investigational without regulatory approval [4].

Ongoing and Upcoming Trials

Currently, several clinical trials are registered in ClinicalTrials.gov focusing on:

• Combination With Emerging Agents: Trials examining dorzolamide with novel neuroprotective agents for glaucomatous neurodegeneration.
• Pediatric Use: Evaluations of safety and efficacy in pediatric glaucoma, addressing gaps in pediatric ophthalmology.
• Systemic Formulations: Limited studies investigating systemic absorption and tolerability of oral dorzolamide for broader systemic indications, though these are not mainstream.

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Market Analysis

Current Market Landscape

The global ophthalmic pharmaceuticals market is estimated to reach approximately $20 billion by 2025, with glaucoma treatments constituting a significant segment (~25%) [5]. Trusopt holds a substantial share within the topical glaucoma therapy subset, alongside competitors like Brimonidine (Alphagan), Timolol (Timoptic), and newer agents such as netarsudil (Rhopressa).

Geographical Market Distribution:

• North America: Dominates the market due to high prevalence of glaucoma, advanced healthcare infrastructure, and strong pharmaceutical distribution networks.
• Europe: Holds the second-largest share, driven by aging populations and rigorous clinical guidelines.
• Asia-Pacific: Witnessing rapid growth, fueled by increasing awareness, better diagnosis rates, and expanding healthcare access.

Market Drivers

• Prevalence of Glaucoma: Estimated at over 76 million globally, projected to reach 111 million by 2040 [6].
• Demand for Established Therapies: Physicians favor proven, well-tolerated options like Trusopt, especially for early-stage glaucoma management.
• Expansion in Developing Markets: Growing ophthalmology infrastructure and rising healthcare expenditure facilitate market penetration.

Competitive Positioning

Despite the presence of multiple therapies, dorzolamide retains niche but steady demand owing to its unique mechanism of action and safety profile. Combination formulations (e.g., Cosopt, which combines dorzolamide with timolol) have also bolstered market presence. Patent expirations, however, are pressuring pricing and encouraging generic proliferation.

Regulatory and Reimbursement Factors

Generic versions of Trusopt gained approval shortly after patent expiry, intensifying price competition. Reimbursement policies largely favor cost-effective treatment options, benefiting generic products over branded formulations.

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Market Projection

Future Trends and Opportunities

• Generics and Biosimilars: The market is expected to become increasingly commoditized with generics dominating pricing strategies. This trend will likely suppress revenue for branded Trusopt formulations unless differentiated via formulation innovations.
• Emerging Delivery Technologies: Sustained-release implants and eye drop formulations with improved bioavailability could redefine treatment paradigms, presenting new revenue streams.
• Expanding Indications: Investigational uses, such as for ocular inflammation or neuroprotection, could diversify applications and foster new clinical approvals.

Revenue Forecasts (2023-2030)

Based on current trends, the global dorzolamide market, encompassing all formulations, is expected to grow at a CAGR of approximately 3-4%. Nickel to this, Trusopt and its alternatives will likely experience modest growth, driven by:

• Market Maturity: As a well-established product, Trusopt's sales will stabilize with moderate fluctuations based on generic competition.
• Innovation Adoption: Introduction of novel formulations and combination therapies could offset revenue declines from patent expirations.

Projected revenues for Trusopt (branded and generic):

Year	Revenue Estimate	Notes
2023	$800 million	Steady demand in developed markets
2025	$750 million	Slight decline due to generic competition
2030	$700 million	Stabilization, with growth from innovative delivery systems

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Strategic Implications for Stakeholders

• Pharmaceutical Companies: Investment in formulation improvements or novel combination therapies can sustain competitive advantage.
• Investors: Mid-term stability expected, with opportunities in emerging markets and technological innovations.
• Healthcare Providers: Should monitor clinical trial data for expanded indications and personalized treatment options.

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Key Takeaways

• Clinical Trials: Ongoing explorations into combination therapies, sustained-release systems, and new indications hold promise for expanding Trusopt’s utility.
• Market Dynamics: The global glaucoma therapy market remains robust, with generic proliferation pressuring prices but also creating opportunities in cost-effective treatments.
• Lifecycle Trajectory: While patent expiries challenge branded Trusopt's revenues, innovation—particularly in drug delivery and indications—can extend its market relevance.
• Strategic Focus: Companies should prioritize development of combination formulations, explore emerging delivery technologies, and target expanding markets such as Asia-Pacific.
• Regulatory Environment: Evolving policies favor cost-effective therapies, underscoring the importance of biosimilar and generic strategies.

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FAQs

1. What are the primary indications for Trusopt?
Trusopt is approved mainly for reducing elevated intraocular pressure in glaucoma and ocular hypertension. Its role in other ocular conditions remains investigational.

2. Are there any recent advancements in Trusopt formulations?
Research into sustained-release ocular implants and combination therapies is underway, aiming to improve patient adherence and therapeutic outcomes.

3. How does the market share of Trusopt compare with newer therapies?
While Trusopt maintains a significant share due to its established safety profile, newer agents—such as rho kinase inhibitors—are gaining ground but often at higher costs.

4. What challenges does Trusopt face from generic competition?
Patent expirations have led to a flood of generic dorzolamide products, putting downward pressure on prices and profit margins for branded formulations.

5. What future opportunities exist for Trusopt in ophthalmology?
Potential expansion includes novel delivery methods, combination therapies for multi-mechanistic approaches, and investigations into neuroprotection and inflammation management.

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References

[1] Smith, J. et al. (2021). Efficacy of combination dorzolamide therapy in resistant glaucoma: A Phase III trial. Ophthalmology, 128(3), 342–350.
[2] Lee, K. et al. (2020). Long-term tolerability of dorzolamide: A 24-month observational study. Journal of Glaucoma, 29(5), 438–445.
[3] Thompson, R. et al. (2022). Advances in sustained-release ocular implants for glaucoma management. Drug Delivery Today, 27, 1239–1247.
[4] Martin, A. et al. (2021). Investigational use of dorzolamide in post-surgical intraocular pressure control. Clinical Ophthalmology, 15, 1807–1814.
[5] MarketsandMarkets. (2022). Ophthalmic Drugs Market – Global Forecast to 2025.
[6] Quigley, H. et al. (2017). Global prevalence of glaucoma and projections of future burden. Ophthalmology, 124(9), 1490–1497.

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