Safety and Efficacy Study of DuoTrav APS Versus DuoTrav

Alcon

Status and phase: Withdrawn; Phase 3

Conditions: Open-angle Glaucoma; Ocular Hypertension

Treatments: Drug: DuoTrav APS; Drug: DuoTrav

Study type: Interventional

Funder types: Industry

Identifiers

NCT00862472

C-09-006

Details and patient eligibility

About

The purpose of the study is to demonstrate that the IOP-lowering efficacy of DuoTrav APS, dosed once-daily in the morning, is non-inferior to that of DuoTrav, dosed once-daily in the morning.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with open-angle glaucoma or ocular hypertension who would benefit from a fixed combination medication, in the opinion of the investigator and who are currently on a stable treatment of IOP-lowering medication

Exclusion criteria

• VA not worse than 0.60
• additional clinically relevant ocular or systemic conditions may be excluded

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

DuoTrav APS

Experimental group

Description:

DuoTrav APS QD AM

Treatment:

Drug: DuoTrav APS

DuoTrav

Active Comparator group

Description:

DuoTrav QD AM

Treatment:

Drug: DuoTrav