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RKI983

Phase 1

Glaucoma | Small molecule | Ophthalmology |Novartis AG|Last Updated: Dec 28, 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment90

FDA Designations

No designations recorded

Clinical trial landscape

RKI983 · 1 trial · 2 indications

Phase 1 1
NCT00515424Tolerability, Safety and Efficacy of RKI983 Eye Drops in Subjects With Primary Open Angle Glaucoma and Ocular HypertensionGlaucoma
COMPLETED90 Analytics
PHASE1COMPLETED
Tolerability, Safety and Efficacy of RKI983 Eye Drops in Subjects With Primary Open Angle Glaucoma and Ocular Hypertension
GlaucomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Rates of adverse events and serious adverse events, as well as changes in ophthalmic evaluations, laboratory values, ECGs and vital signs over period of 7 days treatment.

Secondary Endpoints

Change in ocular hypertension from Baseline to Day 7.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
RKI983DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Males and females, ≥18 years of age, with primary open angle glaucoma and ocular hypertension * Females must be post-menopausal or surgically sterile Exclusion Criteria: * Other types of glaucoma * Eye pressure lowering surgeries * A history of or current eye conditions or m...

Countries:United States
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Frequently asked questions about RKI983

What is RKI983 used for?

RKI983 is an investigational small molecule being developed for the treatment of glaucoma. It is formulated as eye drops and has been studied in patients with primary open angle glaucoma and ocular hypertension. The drug is currently in Phase 1 clinical development.

Who makes RKI983?

RKI983 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is in Phase 1 clinical development for the treatment of glaucoma.

What phase is RKI983 in?

RKI983 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 trial evaluating the drug has been completed, with no active trials currently ongoing.

What clinical trials is RKI983 in?

RKI983 has been studied in one clinical trial, identified as NCT00515424. This Phase 1 study, titled "Tolerability, Safety and Efficacy of RKI983 Eye Drops in Subjects With Primary Open Angle Glaucoma and Ocular Hypertension," was completed in the United States with 90 participants.

Is RKI983 FDA approved?

RKI983 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. A Phase 1 trial has been completed, but the drug has not yet received regulatory approval for the treatment of glaucoma.