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.
NCT00619034 ↗	Pharmacological Intervention in Diabetic Retinopathy	Completed	University of Aarhus	N/A	2007-09-01	The purpose of this study is to determine if diabetic retinopathy can be treated with prostaglandin analogues, prostaglandin synthesis inhibitors or carbonic anhydrases inhibitors.

Clinical Trial Conditions for Trusopt

Condition Name

Condition Name for Trusopt
Intervention	Trials
Glaucoma	5
Primary Open Angle Glaucoma	2
Ocular Hypertension	2
Open-Angle Glaucoma	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

Trusopt (Dorzolamide Hydrochloride): Clinical Trials, Market Analysis, and Projections

Introduction to Trusopt

Trusopt, known generically as dorzolamide hydrochloride, is a groundbreaking medication developed by Dr. Thomas H. Maren, a researcher at the University of Florida. It was the first topical treatment for glaucoma, revolutionizing the way this condition is managed. Here, we will delve into the clinical trials, market analysis, and future projections for Trusopt.

Clinical Trials and Efficacy

Monotherapy Studies

Clinical trials have consistently demonstrated the efficacy of Trusopt in reducing intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. In a one-year controlled trial, Trusopt 2% administered three times a day was compared to betaxolol 0.5% and timolol 0.5%. The results showed that Trusopt achieved mean percent reductions in IOP of 23% at peak and 17% at afternoon trough, which were comparable to the other treatments[1].

In a dose-response study, patients treated with Trusopt 2% three times a day showed significant reductions in IOP, with mean percent reductions of 13% at morning trough and 16% at peak after six weeks. This efficacy was maintained over a one-year treatment period[1].

Adjunctive Therapy

Trusopt has also been shown to be effective as an adjunctive therapy to beta-blockers. In a one-week placebo-controlled study, adding Trusopt 2% twice a day to patients already on timolol 0.5% resulted in additional mean percent reductions in IOP of 17% at morning trough and 21% at peak[1].

A six-month dose-comparison study further confirmed that Trusopt, when used in conjunction with timolol, provided comparable efficacy to pilocarpine 2% as an adjunctive therapy[1].

Mechanism of Action

Trusopt works by inhibiting carbonic anhydrase II in the ciliary processes of the eye, which decreases aqueous humor secretion. This reduction in aqueous humor production leads to a decrease in intraocular pressure, thereby protecting the optic nerve and preventing further vision loss[3].

Safety and Tolerability

Clinical studies have shown that Trusopt is generally well-tolerated. Common adverse reactions include conjunctivitis, lid reactions, blurred vision, eye redness, tearing, dryness, and photophobia. Systemic reactions such as headache, nausea, and asthenia/fatigue are less common[3].

The safety profile of Trusopt in pediatric patients is similar to that in adults, as demonstrated in a 3-month, double-masked, active-treatment-controlled trial. There were no significant differences in safety or effectiveness between elderly and younger patients[3].

Market Analysis

Current Market Size and Growth

The glaucoma treatment market, which includes Trusopt, was valued at $7.9 billion in 2020 and is projected to reach $13.54 billion by 2028. This growth is driven by the increasing prevalence of glaucoma and the need for effective treatments[2].

Ophthalmology Drug and Device Market

The broader ophthalmology drug and device market is expected to reach $92.14 billion by 2025 and grow at a CAGR of 5.47% to reach $120.25 billion by 2030. Key factors driving this growth include new product launches, a high concentration of market players, and the recovery from the COVID-19 pandemic[5].

Regional Market Dynamics

North America currently holds the largest market share in the ophthalmology drug and device market, driven by continuous product launches and a strong presence of market players. The Asia Pacific region is expected to grow at the highest CAGR over the forecast period[5].

Impact of University Innovation

The development of Trusopt is a prime example of how university innovation can transform healthcare. Dr. Thomas H. Maren's work at the University of Florida led to the creation of this groundbreaking medication, which has significantly improved the treatment of glaucoma. The University of Florida received over $250 million in royalties from Trusopt, which has been reinvested in new research, highlighting the potential for academic innovation to drive medical advancements and economic growth[2].

Key Takeaways

• Clinical Efficacy: Trusopt has been proven effective in reducing IOP in patients with glaucoma or ocular hypertension, both as monotherapy and as adjunctive therapy.
• Mechanism of Action: Trusopt inhibits carbonic anhydrase II, reducing aqueous humor secretion and lowering IOP.
• Safety and Tolerability: Trusopt is generally well-tolerated, with common adverse reactions being mild and transient.
• Market Growth: The glaucoma treatment market and the broader ophthalmology drug and device market are expected to grow significantly, driven by new product launches and increasing demand.
• University Innovation: The development of Trusopt exemplifies the impact of university research on healthcare and the economy.

FAQs

What is Trusopt used for?

Trusopt (dorzolamide hydrochloride) is used to treat elevated intraocular pressure in patients with glaucoma or ocular hypertension.

Who developed Trusopt?

Trusopt was developed by Dr. Thomas H. Maren, a researcher at the University of Florida.

What is the mechanism of action of Trusopt?

Trusopt works by inhibiting carbonic anhydrase II in the ciliary processes of the eye, reducing aqueous humor secretion and lowering intraocular pressure.

What are the common side effects of Trusopt?

Common side effects include conjunctivitis, lid reactions, blurred vision, eye redness, tearing, dryness, and photophobia.

How is the market for glaucoma treatments expected to grow?

The glaucoma treatment market is expected to grow from $7.9 billion in 2020 to $13.54 billion by 2028.

What is the projected size of the ophthalmology drug and device market by 2030?

The ophthalmology drug and device market is expected to reach $120.25 billion by 2030, growing at a CAGR of 5.47% from 2025 to 2030.

Sources

1. TRUSOPT® (dorzolamide hydrochloride) - E-lactancia
   • A comparative crossover clinical trial and other efficacy studies.
2. When University Innovation Changed the World: Trusopt - FirstIgnite
   • Market size and growth projections, impact of university innovation.
3. TRUSOPT® (dorzolamide hydrochloride ophthalmic solution) 2% - FDA
   • Clinical studies, mechanism of action, safety, and tolerability.
4. Effect of Adjuvant Topical Dorzolamide-Timolol vs Placebo in ... - JAMA Ophthalmology
   • Randomized clinical trial comparing dorzolamide-timolol vs placebo.
5. Ophthalmology Drug & Device Market Size & Share Analysis - Mordor Intelligence
   • Market size, growth projections, and regional dynamics.

Last updated: 2025-01-07