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INS115644

Phase 1

Ocular Hypertension | Small molecule | Ophthalmology |Merck & Company, Inc.|Last Updated: Jan 21, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

Clinical trial landscape

INS115644 · 1 trial · 2 indications

Phase 1 1
NCT00443924Study of INS115644 Ophthalmic Solution in Subjects With Ocular Hypertension or GlaucomaOcular Hypertension
COMPLETED56 Analytics
PHASE1COMPLETED
Study of INS115644 Ophthalmic Solution in Subjects With Ocular Hypertension or Glaucoma
Ocular HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability
28 days
Changes in intraocular pressure
28 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1PLACEBO_COMPARATORArm 1
2EXPERIMENTALArm 2
3EXPERIMENTALArm 3
4EXPERIMENTALArm 4
5EXPERIMENTALArm 5

Interventions

NameTypeDescription
INS115644 Ophthalmic SolutionDRUGOne drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for three days
PlaceboDRUGOne drop of placebo in each eye every 12 hours for three days
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Have a diagnosis of bilateral ocular hypertension or early primary open angle glaucoma * Have best corrected visual acuity in both eyes of at least +0.5 or better * Have normal endothelial cell counts and morphology Exclusion Criteria: * Are diagnosed with closed angle glauc...

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Competitive Landscape -Ocular Hypertension 8 trials

Frequently asked questions about INS115644

What is INS115644 used for?

INS115644 is an investigational small molecule being developed for the treatment of ocular hypertension and open angle glaucoma. It is formulated as an ophthalmic solution and is currently in Phase 1 clinical development.

Who makes INS115644?

INS115644 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK.

What phase is INS115644 in?

INS115644 is in Phase 1 clinical development. It has completed one Phase 1 trial, and it is not yet approved by the FDA. The drug remains investigational and is still undergoing clinical evaluation.

What clinical trials is INS115644 in?

INS115644 has been studied in one completed Phase 1 clinical trial, identified as NCT00443924. This trial evaluated the ophthalmic solution in subjects with ocular hypertension or open angle glaucoma and enrolled 56 participants.

Is INS115644 FDA approved?

INS115644 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial. Further clinical development and regulatory review would be required before any approval could be considered.