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timolol/dorzolamide combination

Phase 3

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment367
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00108017Comparison of the Effects of Two Glaucoma Drugs Over 24 Hours (0507A-137)(COMPLETED)PHASE3 COMPLETED 330Apr 1, 2005Jul 1, 2006May 13, 2015 -
NCT00832377COSOPT (Timolol/Dorzolamide Combination) Normal Tension Glaucoma Study (MK0507A-161)(COMPLETED)PHASE2 COMPLETED 37Apr 24, 2009Mar 26, 2010Sep 29, 2017 -
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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 — 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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