A Multicenter, Randomized, Placebo-Controlled, Latanoprost-Controlled, Parallel Group Study to Assess the Tolerability, Safety and Efficacy of RKI983 Ophthalmic Solution Given Twice a Day Over One Week in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension

Novartis0 sites90 target enrollmentJuly 2007

ConditionsGlaucoma Ocular Hypertension

DrugsRKI983

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Glaucoma
Sponsor: Novartis
Enrollment: 90
Primary Endpoint: 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.
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This study will evaluate the tolerability and safety of RKI983 ophthalmic solution and explore the effect of the compound on intraocular pressure in subjects with ocular hypertension.

Registry

clinicaltrials.gov

Start Date

July 2007

End Date

TBD

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis

Eligibility Criteria

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 medical problems that would prohibit the use of an investigational drug
•Other protocol-defined inclusion/exclusion criteria may apply.

Outcomes

Primary Outcomes

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.