Tolerability, Safety and Efficacy of RKI983 Eye Drops in Subjects With Primary Open Angle Glaucoma and Ocular Hypertension

Phase 1

Completed

• Conditions: Glaucoma; Ocular Hypertension

• Registration Number: NCT00515424
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-08-09
• Study First Submitted QC: 2007-08-10
• Study First Posted: 2007-08-13
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-19
• Last Update Posted: 2007-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change in ocular hypertension from Baseline to Day 7.