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timolol/dorzolamide combination

Phase 4

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

timolol/dorzolamide combination development status

Highest phase Phase 4 run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (NCT00140049)
Phase scored for MRKPhase 2
Registered trials 5 across 3 sponsors since Aug 2005

timolol/dorzolamide combination target and mechanism

Molecular targetADRB1, ADRB2
Target classAntagonist
ModalitySmall molecule
ChEMBLCHEMBL499

Also known as Cosopt

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment37

FDA Designations

No designations recorded

timolol/dorzolamide combination clinical trials

timolol/dorzolamide combination · 1 trial · 1 indication

Phase 2 1
NCT00832377COSOPT (Timolol/Dorzolamide Combination) Normal Tension Glaucoma Study (MK0507A-161)(COMPLETED)Glaucoma
COMPLETED37 Analytics
PHASE2COMPLETED
COSOPT (Timolol/Dorzolamide Combination) Normal Tension Glaucoma Study (MK0507A-161)(COMPLETED)
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Study Endpoints

Primary Endpoints

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

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

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

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

Interventions

NameTypeDescription
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 who have not been treated with a glaucoma medication within 6 weeks prior to study participation after diagnosis with primary open-angle glaucoma * Patients with primary open-angle glaucoma based on gonioscopy * Patients with normal tension glaucoma diagnosed based on...

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Frequently asked questions about timolol/dorzolamide combination

What is timolol/dorzolamide combination?

Timolol/dorzolamide combination is a small molecule ophthalmic product developed by Merck & Company, Inc. (ticker MRK) for glaucoma. It combines timolol maleate with dorzolamide and has been studied in a Phase 2 trial in patients with normal tension glaucoma. It is an investigational combination rather than a newly approved product.

What does timolol/dorzolamide combination target?

Timolol/dorzolamide combination includes timolol, which acts as an antagonist at the beta-adrenergic receptors ADRB1 and ADRB2. By blocking these receptors, timolol reduces aqueous humor production in the eye. The dorzolamide component is a carbonic anhydrase inhibitor that also lowers aqueous humor formation, so the combination targets two pathways that reduce intraocular pressure in glaucoma.

Who makes timolol/dorzolamide combination?

Merck & Company, Inc., which trades under the ticker MRK, is the developer of the timolol/dorzolamide combination. The company sponsored the clinical program evaluating this fixed combination product in glaucoma, including the Phase 2 study conducted in patients with normal tension glaucoma.

What phase is timolol/dorzolamide combination in?

Timolol/dorzolamide combination is in Phase 2 development for glaucoma. One Phase 2 trial has been completed, and no active trials are currently listed. The program remains investigational and is not described as approved by the FDA for any indication.

What clinical trials is timolol/dorzolamide combination in?

The timolol/dorzolamide combination has been studied in one completed Phase 2 trial, NCT00832377, titled the COSOPT (Timolol/Dorzolamide Combination) Normal Tension Glaucoma Study (MK0507A-161). That trial enrolled 37 participants aged 18 years and older of all sexes, was uncontrolled, and has completed.

Is timolol/dorzolamide combination the same as timolol maleate or timolol?

Timolol/dorzolamide combination is a fixed combination product that contains timolol, and timolol maleate and timolol are the comparator names used for that beta-blocker component. The combination pairs timolol with dorzolamide, so it is not identical to timolol alone; it is a separate combination therapy studied in glaucoma.