Safety and Efficacy Study of DuoTrav APS Versus DuoTrav

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00862472

Enrollment

Registered

2009-03-17

Start date

2009-03-31

Completion date

2009-06-30

Last updated

2012-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open-angle Glaucoma, Ocular Hypertension

Keywords

open-angle glaucoma, ocular hypertension, open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component)

Brief summary

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.

Interventions

DRUGDuoTrav APS

DuoTrav APS QD AM

DRUGDuoTrav

DuoTrav QD AM

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Mean Intraocular Pressure (IOP)	3 Months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026