CLINICAL TRIALS PROFILE FOR DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

All Clinical Trials for Dorzolamide Hydrochloride And 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 And Timolol Maleate

Condition Name

Condition Name for Dorzolamide Hydrochloride And Timolol Maleate
Intervention	Trials
Glaucoma	5
Ocular Hypertension	5
Open-Angle Glaucoma	3
Exfoliation Syndrome	1

Condition MeSH

Condition MeSH for Dorzolamide Hydrochloride And Timolol Maleate
Intervention	Trials
Glaucoma	8
Ocular Hypertension	6
Glaucoma, Open-Angle	4
Hypertension	4

Clinical Trial Locations for Dorzolamide Hydrochloride And Timolol Maleate

Trials by Country

Trials by Country for Dorzolamide Hydrochloride And Timolol Maleate
Location	Trials
United States	8
Brazil	1
Israel	1
Portugal	1

Trials by US State

Trials by US State for Dorzolamide Hydrochloride And Timolol Maleate
Location	Trials
Florida	1
Indiana	1
Massachusetts	1
South Carolina	1
Oklahoma	1

Clinical Trial Progress for Dorzolamide Hydrochloride And Timolol Maleate

Clinical Trial Phase

Clinical Trial Phase for Dorzolamide Hydrochloride And Timolol Maleate
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	2
Phase 1	1

Clinical Trial Status

Clinical Trial Status for Dorzolamide Hydrochloride And Timolol Maleate
Clinical Trial Phase	Trials
Completed	4
Withdrawn	2
Unknown status	1

Clinical Trial Sponsors for Dorzolamide Hydrochloride And Timolol Maleate

Sponsor Name

Sponsor Name for Dorzolamide Hydrochloride And Timolol Maleate
Sponsor	Trials
Allergan	2
Merck Sharp & Dohme Corp.	2
Pharmaceutical Research Network	1

Sponsor Type

Sponsor Type for Dorzolamide Hydrochloride And Timolol Maleate
Sponsor	Trials
Other	5
Industry	5

Dorzolamide Hydrochloride and Timolol Maleate: Clinical Trials, Market Analysis, and Projections

Last updated: January 2, 2025

Introduction

Dorzolamide hydrochloride and timolol maleate is a widely used fixed-combination ophthalmic solution for the treatment of open-angle glaucoma and ocular hypertension. This combination therapy has been extensively studied and proven effective in reducing intraocular pressure (IOP). Here, we will delve into the recent clinical trials, market analysis, and future projections for this drug.

Mechanism of Action

The combination of dorzolamide hydrochloride and timolol maleate works through two distinct mechanisms to reduce IOP. Dorzolamide hydrochloride is a potent inhibitor of human carbonic anhydrase II (CA-II), which decreases aqueous humor secretion by slowing the formation of bicarbonate ions and subsequent reduction in sodium and fluid transport. Timolol maleate, on the other hand, is a nonselective beta-adrenergic receptor blocking agent that reduces aqueous humor production without significant intrinsic sympathomimetic, direct myocardial depressant, or local anesthetic activity[1].

Clinical Trials Update

Efficacy and Safety

Recent clinical trials have reinforced the efficacy and safety of dorzolamide hydrochloride and timolol maleate. A study published in the Journal of Drug Assessment found that increasing the dosage from twice a day to three times a day significantly reduced IOP in patients with primary open-angle glaucoma (POAG). The study showed a 28.5% average IOP reduction after one month of twice-daily administration, and a further reduction to 39.8% after switching to three times a day administration[2].

Preservative-Free Formulation

Another significant development is the introduction of a preservative-free formulation of dorzolamide hydrochloride and timolol maleate. Clinical trials have demonstrated that this preservative-free version is as effective as the preserved formulation in reducing IOP, with no significant differences in adverse reactions. This is particularly beneficial for patients who are sensitive to preservatives like benzalkonium chloride[3][4].

Long-Term Studies

Long-term studies have also been conducted to assess the sustained efficacy and safety of this combination therapy. A 60-month evaluator-masked study involving 161 POAG patients found that adding dorzolamide 2% or brinzolamide 1% to timolol 0.5% effectively slowed visual field progression. This study highlights the long-term benefits of using dorzolamide hydrochloride and timolol maleate in managing glaucoma[5].

Market Analysis

Market Position

Dorzolamide hydrochloride and timolol maleate, marketed under names such as Cosopt, is one of the most frequently prescribed fixed-combination therapies for glaucoma. Its market position is strong due to its proven efficacy and safety profile. The drug is widely available in many countries and is often preferred over monotherapy due to its synergistic effect in reducing IOP[2][4].

Competitive Landscape

The glaucoma treatment market is competitive, with various other medications and combination therapies available. However, the combination of dorzolamide hydrochloride and timolol maleate remains a leading choice due to its well-established clinical benefits and patient compliance. The introduction of preservative-free formulations has further enhanced its market appeal, particularly among patients with preservative sensitivity[3][4].

Patient Compliance

Patient compliance is a critical factor in the management of chronic conditions like glaucoma. The simplicity of using a single combination product rather than multiple medications can improve adherence. Clinical trials have shown that patients find this combination therapy easy to use and effective, contributing to higher compliance rates[2].

Projections

Future Trends

The demand for effective glaucoma treatments is expected to rise due to the increasing prevalence of glaucoma, particularly in aging populations. The combination of dorzolamide hydrochloride and timolol maleate is likely to remain a cornerstone in glaucoma management. Advances in formulation, such as preservative-free options, will continue to enhance patient comfort and compliance.

Market Growth

The global glaucoma treatment market is projected to grow significantly over the next few years. With its strong clinical profile and market presence, dorzolamide hydrochloride and timolol maleate is expected to contribute substantially to this growth. The introduction of new formulations and potential expansion into new markets will further drive its market share[4].

Regulatory Environment

Regulatory approvals and guidelines play a crucial role in the market dynamics of pharmaceuticals. The FDA's approval of preservative-free formulations and the cross-referencing of studies for new indications will continue to support the market presence of dorzolamide hydrochloride and timolol maleate. Compliance with regulatory standards will be essential for maintaining and expanding market share[3][4].

Adverse Reactions and Safety Profile

Common Adverse Reactions

Clinical trials have shown that the combination of dorzolamide hydrochloride and timolol maleate is generally well-tolerated. Common adverse reactions are mild and include eye burning, stinging, or redness. Serious adverse reactions are rare and typically related to the individual components rather than the combination itself[1].

Long-Term Safety

Long-term studies have not identified any significant safety concerns specific to the combination therapy. The safety profile is consistent with that of the individual components, with no new or unexpected adverse reactions reported[5].

Key Takeaways

• Efficacy: Dorzolamide hydrochloride and timolol maleate significantly reduce IOP, with increased efficacy observed with higher dosages.
• Safety: The combination therapy is well-tolerated, with mild and rare serious adverse reactions.
• Market Position: It remains a leading choice in glaucoma treatment due to its proven clinical benefits and patient compliance.
• Future Trends: The demand is expected to rise, driven by the increasing prevalence of glaucoma and advances in formulations.
• Regulatory Environment: Compliance with FDA guidelines and approvals will support its market presence.

FAQs

Q: What is the mechanism of action of dorzolamide hydrochloride and timolol maleate?

A: Dorzolamide hydrochloride inhibits carbonic anhydrase II, reducing aqueous humor secretion, while timolol maleate blocks beta-adrenergic receptors, also reducing aqueous humor production[1].

Q: Is the preservative-free formulation as effective as the preserved one?

A: Yes, clinical trials have shown that the preservative-free formulation is as effective as the preserved formulation in reducing IOP[3][4].

Q: What are the common adverse reactions associated with this combination therapy?

A: Common adverse reactions include eye burning, stinging, or redness, and are generally mild[1].

Q: How does the combination therapy impact patient compliance?

A: The simplicity of using a single combination product improves patient compliance compared to using multiple medications[2].

Q: What are the future projections for the market share of dorzolamide hydrochloride and timolol maleate?

A: The market share is expected to grow due to the increasing prevalence of glaucoma and the introduction of new formulations[4].

Sources

1. MED-DORZOLAMIDE-TIMOLOL (dorzolamide hydrochloride and timolol maleate)
   • PDF: Dorzolamide and Timolol Ophthalmic Solution[1].
2. Study Finds Increased Dosage of Timolol-Dorzolamide Fixed Combination Safe and Effective in Open-Angle Glaucoma
   • Article: Increasing dosage of timolol-dorzolamide fixed combination[2].
3. 202667Orig1s000 - accessdata.fda.gov
   • PDF: Study 081, preservative-free dorzolamide hydrochloride /0.5% Timolol Maleate[3].
4. 202667Orig1s000MedR.pdf
   • PDF: NDA 202667 Cosopt PF (dorzolamide hydrochloride - timolol maleate ophthalmic solution)[4].
5. Predictors for visual field progression and the effects of treatment with dorzolamide 2% or brinzolamide 1% each added to timolol 0.5%
   • Article: Long-term study on visual field progression[5].