Tolerability, Safety and Efficacy of SAD448 in Subjects With Ocular Hypertension

Novartis

Status and phase: Completed; Phase 1

Conditions: Ocular Hypertension

Treatments: Drug: SAD448

Study type: Interventional

Funder types: Industry

Identifiers

NCT00503360

CSAD448B2101

Details and patient eligibility

About

This study will evaluate the tolerability and safety of SAD448 and explore the compound's effect on intraocular pressure in subjects with ocular hypertension.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key inclusion criteria:

• Males and females, 18 - 65 years of age, with ocular hypertension
• Females must be post-menopausal or surgically sterile

Key exclusion criteria:

• Diagnosis of glaucoma in either eye
• A history of or current eye conditions or medical problems that would prohibit the use of an investigational drug

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind