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dorzolamide timolol

Phase 3

Glaucoma | Small molecule | Ophthalmology |Merck & Company, Inc.|Last Updated: Jun 20, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials2
Total Enrollment644

FDA Designations

No designations recorded

Clinical trial landscape

dorzolamide timolol · 2 trials · 2 indications

Phase 3 2
NCT00449956MK0507A Clinical Study in Patients With Glaucoma and Ocular Hypertension (0507A-149)(COMPLETED)Glaucoma
COMPLETED474 Analytics
NCT00546286A Study to Evaluate the Effectiveness of Cosopt® as First Line Therapy (MK-0507A-153)Glaucoma
COMPLETED170 Analytics
PHASE3COMPLETED
MK0507A Clinical Study in Patients With Glaucoma and Ocular Hypertension (0507A-149)(COMPLETED)
GlaucomaUnlock trial analytics
PHASE3COMPLETED
A Study to Evaluate the Effectiveness of Cosopt® as First Line Therapy (MK-0507A-153)
GlaucomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in Intraocular Pressure (IOP) From Baseline at 8 Weeks
8 weeks

Change from baseline to 8 weeks in Intraocular Pressure (IOP) assessed 2 hours after ocular instillation (at Hour 2)

Reduction in IOP 4 mmHg (or >= 20%) over a period of 6 or 12 weeks.
6 to 12 weeks

Secondary Endpoints

Percent Change From Baseline in Intraocular Pressure (IOP) at 8 Weeks
8 Weeks
Percent Change From Baseline in Outflow Pressure Reduction Rate at 8 Weeks
8 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALcombination of dorzolamide hydrochloride and timolol maleate
2ACTIVE_COMPARATORConcomitant use of dorzolamide hydrochloride and timolol maleate
3ACTIVE_COMPARATORtimolol maleate

Interventions

NameTypeDescription
dorzolamide hydrochloride (+) timolol maleateDRUGDorzolamide hydrochloride 1% + timolol 0.5%, 8-week
Comparator: timolol maleateDRUGtimolol maleate 0.5%, 8-week
Comparator: dorzolamide hydrochlorideDRUGdorzolamide hydrochloride 1%, 8-week
Comparator: dorzolamide HCl/timolol maleate + prostaglandinDRUGCombination treatment of dorzolamide HCl (2%)/timolol maleate(0.5%) BID for six weeks in patients with open-angle glaucoma or ocular hypertension. For patients not achieving target IOP at 6 weeks, a prostaglandin is added for another 6 weeks.
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Eligibility Criteria

Age Range20 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patients with glaucoma and ocular hypertension Exclusion Criteria: * History of ocular surgery within 3 months * Administration contradiction to timolol and dorzolamide

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Frequently asked questions about dorzolamide timolol

What is dorzolamide timolol used for?

Dorzolamide timolol is used for glaucoma, including ocular hypertension. It is a small molecule being developed by Merck & Company, Inc. for the treatment of these eye conditions. The drug is currently in Phase 3 clinical development, with completed trials evaluating its effectiveness in patients with glaucoma and ocular hypertension.

What does dorzolamide timolol target?

Dorzolamide timolol is a combination of two active ingredients: dorzolamide, a carbonic anhydrase inhibitor, and timolol, a beta-blocker. Together, they work to reduce intraocular pressure in patients with glaucoma and ocular hypertension by decreasing the production of fluid in the eye.

Who makes dorzolamide timolol?

Dorzolamide timolol is developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is being studied for the treatment of glaucoma and ocular hypertension.

What phase is dorzolamide timolol in?

Dorzolamide timolol is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. Two Phase 3 trials have been completed, with a total of 644 patients enrolled, but the drug remains under investigation.

What clinical trials is dorzolamide timolol in?

Dorzolamide timolol has completed two Phase 3 clinical trials. The first, NCT00449956, enrolled 474 patients with glaucoma. The second, NCT00546286, enrolled 170 patients with glaucoma and ocular hypertension. Both trials were randomized, double-blind, and controlled, and have been completed.

Is dorzolamide timolol the same as Cosopt?

Dorzolamide timolol is the same as Cosopt, as indicated by the clinical trial NCT00546286, which evaluates the effectiveness of Cosopt as first-line therapy. Cosopt is a brand name for the combination of dorzolamide and timolol, used to treat glaucoma and ocular hypertension.