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CLINICAL TRIALS PROFILE FOR DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

Clinical Trials for Dorzolamide Hydrochloride And Timolol Maleate

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Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00108017	Comparison of the Effects of Two Glaucoma Drugs Over 24 Hours (0507A-137)(COMPLETED)	Completed	Merck Sharp & Dohme Corp.	Phase 3	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	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	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	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	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
NCT00811850	Comparing Effects of Two Fixed Combinations Ophthalmic Solutions on Ocular Blood Flow	Completed	Allergan	Phase 4	A 10 week evaluation, crossover design study including a 3 week washout period between treatments, to determine the effects of Combigan® (fixed combination brimonidine tartrate 0.2%/timolol maleate 0.5%) and Cosopt® (fixed combination dorzolamide hydrochloride-timolol maleate ophthalmic solutions) on ocular blood flow as measured by retrobulbar blood flow.
NCT00815373	The Effects of Cosopt® Vs Xalacom® on Ocular Hemodynamics and Intraocular Pressure (IOP) in Primary Open-angle Glaucoma (POAG)	Withdrawn	Meir Medical Center	N/A	Both Cosopt® and Xalatan® plus Timoptic® will significantly lower IOP, however only Cosopt® will demonstrate positive hemodynamic effects. The clinical significance of this will be investigated by examining the ophthalmic and short posterior ciliary arteries to determine the blood supply to the optic nerve head, the site of damage in glaucoma
Trial ID	Title	Status	Sponsor	Phase	Summary