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

Novartis

Status and phase: Completed; Phase 1

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: RKI983

Study type: Interventional

Funder types: Industry

Identifiers

NCT00515424

CRKI983A2101

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind