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timolol/dorzolamide combination

Phase 3

Glaucoma | Small molecule | Ophthalmology |Merck & Company, Inc.|Last Updated: Sep 29, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment367

FDA Designations

No designations recorded

Clinical trial landscape

timolol/dorzolamide combination · 2 trials · 2 indications

Phase 3 1Phase 2 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
Mean Change in the Peak Intraocular Pressure (IOP) Measured Two Hours After Study Drug Administration at Week 12 Compared to Baseline IOP.
Baseline and 12 weeks

The therapeutic goal of normal tension glaucoma treatment includes lowering IOP to prevent progression of damage in optic nerves or vision. In this trial, IOP was measured with the same tonometer throughout the study. A decreased IOP from baseline is considered an improvement. IOP was measured in both eyes and the eye with the higher IOP was used for the participant.

Secondary Endpoints

IOP reduction a) from baseline at 6 weeks; b) comparison with timolol; c) comparison day versus night
At 6 weeks
Mean Change in Trough IOP Measured Right Before Study Drug Administration at Week 12 Compared to Baseline IOP.
Baseline and 12 weeks
Mean Change in IOP 8 Hours After the Study Drug Administration at Week 12 Compared to Baseline IOP
Baseline and 12 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Timolol/DorzolamideEXPERIMENTALTimolol/Dorzolamide, 1 drop, twice daily, for 12 weeks

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 -
timolol/dorzolamide combinationDRUGTimolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
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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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Frequently asked questions about timolol/dorzolamide combination

What is timolol/dorzolamide combination used for?

Timolol/dorzolamide combination is used for glaucoma, including ocular hypertension. It is a fixed-dose combination eye drop being developed by Merck & Company, Inc. (MRK) as a small molecule therapy in the ophthalmology therapeutic area. The drug is currently in clinical development and is not approved.

Who makes timolol/dorzolamide combination?

Merck & Company, Inc. (MRK) is developing timolol/dorzolamide combination. The drug is a small molecule combination therapy for glaucoma and ocular hypertension. It is being studied in clinical trials, including a completed Phase 3 study, but it is not yet approved.

What phase is timolol/dorzolamide combination in?

Timolol/dorzolamide combination is in Phase 3 clinical development. One completed Phase 3 trial (NCT00108017) enrolled 330 patients with glaucoma or ocular hypertension. A second completed Phase 2 trial (NCT00832377) studied 37 patients with normal tension glaucoma. The drug remains investigational.

What clinical trials is timolol/dorzolamide combination in?

Timolol/dorzolamide combination has two completed clinical trials. NCT00108017 was a Phase 3 study comparing the effects of two glaucoma drugs over 24 hours in 330 patients with glaucoma or ocular hypertension. NCT00832377 was a Phase 2 study in 37 patients with normal tension glaucoma. Both trials are completed.

Is timolol/dorzolamide combination the same as COSOPT?

Yes, timolol/dorzolamide combination is also known as COSOPT. The Phase 2 trial NCT00832377 is titled 'COSOPT (Timolol/Dorzolamide Combination) Normal Tension Glaucoma Study,' confirming that COSOPT is the brand name for this combination therapy.