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INS117548

Phase 1

Glaucoma | Small molecule | Ophthalmology |Merck & Company, Inc.|Last Updated: Oct 2, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment84

FDA Designations

No designations recorded

Clinical trial landscape

INS117548 · 1 trial · 1 indication

Phase 1 1
NCT00767793A Placebo-Controlled Study of INS117548 Ophthalmic Solution in Subjects With Glaucoma (P08650)Glaucoma
COMPLETED84 Analytics
PHASE1COMPLETED
A Placebo-Controlled Study of INS117548 Ophthalmic Solution in Subjects With Glaucoma (P08650)
GlaucomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of adverse events
15
Rate of discontinuation
15
Changes in: >Ophthalmic exam parameters >Corneal thickness >Intraocular pressure >Visual Acuity >Physical exam, vital signs and laboratory parameters
15
Compliance
15
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1PLACEBO_COMPARATOROne drop in each eye every 12 hours for seven days
Arm 2EXPERIMENTALOne drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
Arm 3EXPERIMENTALOne drop of Concentration #2 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
Arm 4EXPERIMENTALOne drop of Concentration #3 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days

Interventions

NameTypeDescription
PlaceboDRUGOne drop in each eye every 12 hours for seven days
INS117548DRUGOne drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
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Eligibility Criteria

Age Range18 Years to 80 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 Exclusion Criteria: * Are diagnosed with closed angle glaucoma, exfoliation syndrome or exfoliation glaucoma, an...

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Frequently asked questions about INS117548

What is INS117548 used for?

INS117548 is an investigational small molecule being developed for the treatment of glaucoma. It is formulated as an ophthalmic solution and is intended for use in patients with this condition. The drug is currently in clinical development, having completed a Phase 1 trial.

Who makes INS117548?

INS117548 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company conducted a Phase 1 clinical trial of the drug for the treatment of glaucoma.

What phase is INS117548 in?

INS117548 is in Phase 1 of clinical development. A Phase 1 trial of the drug has been completed. The drug is investigational and has not been approved by regulatory authorities. It is being studied for the treatment of glaucoma.

What clinical trials is INS117548 in?

INS117548 has one completed clinical trial, registered as NCT00767793. This was a Phase 1, placebo-controlled, double-blind, randomized study of INS117548 ophthalmic solution in subjects with glaucoma. The trial enrolled 84 participants aged 18 years and older.

Is INS117548 FDA approved?

INS117548 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial for glaucoma. The drug remains in clinical development and has not yet received regulatory approval for any use.