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MK0507A, dorzolamide timolol

Phase 3

Glaucoma | Small molecule | Ophthalmology |Merck & Company, Inc.|Last Updated: May 13, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment330

FDA Designations

No designations recorded

Clinical trial landscape

MK0507A, dorzolamide timolol · 1 trial · 2 indications

Phase 3 1
NCT00108017Comparison of the Effects of Two Glaucoma Drugs Over 24 Hours (0507A-137)(COMPLETED)Glaucoma
COMPLETED330 Analytics
PHASE3COMPLETED
Comparison of the Effects of Two Glaucoma Drugs Over 24 Hours (0507A-137)(COMPLETED)
GlaucomaUnlock trial analytics

Study Endpoints

Primary Endpoints

24 hour diurnal IOP reduction after 8 weeks of treatment
After 8 weeks of treatment

Secondary Endpoints

IOP reduction a) from baseline at 6 weeks; b) comparison with timolol; c) comparison day versus night
At 6 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Interventions

NameTypeDescription
MK0507A, dorzolamide hydrochloride (+) timolol maleateDRUG -
Comparator: timolol maleateDRUG -
Duration of Treatment: Part 1) 6 wk timolol maleate run inDRUG -
Part 2) 6 wk washout pd Part 3) two 8 wk active tx pdsDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patients with glaucoma or ocular hypertension Exclusion Criteria: * Other eye conditions * Poor vision * Recent eye surgery * Use of contact lenses * Nursing or pregnant women * Use of some other selected medications * Drug or alcohol abuse * Asthma * Slow heart beat * Aller...

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Competitive Landscape -Glaucoma 26 trials

Frequently asked questions about MK0507A, dorzolamide timolol

What is MK0507A used for?

MK0507A is being developed for the treatment of glaucoma, a condition involving increased pressure inside the eye. It is a small molecule combination product in Phase 3 development. Merck & Company, Inc. is the developer, and the drug has also been studied in patients with ocular hypertension.

Who makes MK0507A?

MK0507A is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is the sponsor behind the clinical program for this glaucoma candidate, including the Phase 3 study that has been completed in patients with glaucoma and ocular hypertension.

What phase is MK0507A in?

MK0507A is in Phase 3 development. One Phase 3 trial has been completed, and no active trials are currently listed. The program has enrolled 330 patients in total, and the drug remains an investigational combination product for glaucoma rather than a marketed therapy.

Is MK0507A the same as dorzolamide timolol?

Yes. MK0507A is also known as dorzolamide hydrochloride (+) timolol maleate, so searches for dorzolamide timolol refer to the same asset. It is a small molecule combination product developed by Merck for glaucoma, and it has completed a Phase 3 clinical trial in patients with glaucoma and ocular hypertension.

What clinical trials is MK0507A in?

MK0507A has been studied in the Phase 3 trial NCT00108017, titled Comparison of the Effects of Two Glaucoma Drugs Over 24 Hours (0507A-137). That trial is completed and enrolled 330 patients aged 18 years and older with glaucoma or ocular hypertension. It was randomized and double blind.

How was the MK0507A Phase 3 trial designed?

The Phase 3 trial NCT00108017 was a randomized, double-blind study that enrolled 330 patients with glaucoma or ocular hypertension. Participants were 18 years of age or older, and both sexes were eligible. The study has been completed, and it is the only trial of MK0507A listed for the program.