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NCT00862472 Clinical Trial

Safety and Efficacy Study of DuoTrav APS Versus DuoTrav

Ocular Hypertension Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00862472
Other study ID # C-09-006
Secondary ID
Status Withdrawn
Phase Phase 3
First received March 16, 2009
Last updated January 13, 2012
Start date March 2009
Est. completion date June 2009

Study information
Verified date January 2012
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationNew Zealand: The Standing Committee on Therapeutic Trials and Multi-Region Ethics CommitteeAustralia: Department of Health and Ageing Therapeutic Goods AdministrationTaiwan: Institutional Review BoardTaiwan: Department of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• DuoTrav APS
DuoTrav APS QD AM
• DuoTrav
DuoTrav QD AM

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Alcon Research

Outcome
Type Measure Description Time frame Safety issue
Primary Mean Intraocular Pressure (IOP) 3 Months No
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