Safety Study of DuoTrav APS in Patients With Open-Angle Glaucoma or Ocular Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00928590
First received: June 24, 2009
Last updated: May 16, 2012
Last verified: May 2012

June 24, 2009
May 16, 2012
July 2009
November 2010   (final data collection date for primary outcome measure)
Adverse Events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00928590 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety Study of DuoTrav APS in Patients With Open-Angle Glaucoma or Ocular Hypertension
A Twelve-Month Open-Label Safety Study of Polyquaternium-Preserved DuoTrav APS Dosed Once Daily in Patients With Open-Angle Glaucoma or Ocular Hypertension

The purpose of the study is to describe the long-term safety of a fixed combination product containing an alternative preservative, dosed once daily for 12 months, in patients with open-angle glaucoma or ocular hypertension.

Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Open-angle Glaucoma
  • Ocular Hypertension
Drug: Travoprost/Timolol Maleate Fixed Combination (POLYQUAD-preserved) solution (DuoTrav APS)
One drop in the study eye(s) once daily, at 9 AM, for 12 months
Other Name: DuoTrav APS
Experimental: DuoTrav APS
One drop in the study eye(s) once daily, at 9 AM, for 12 months
Intervention: Drug: Travoprost/Timolol Maleate Fixed Combination (POLYQUAD-preserved) solution (DuoTrav APS)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
155
Not Provided
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with open-angle glaucoma or ocular hypertension who would benefit from a fixed combination medication in the opinion of the investigator.
  • Patients who are currently on a stable treatment of IOP-lowering medication.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • BCVA not worse than 55 letters
  • Additional clinically relevant ocular or systemic conditions may be excluded.
  • Other protocol-defined exclusion criteria may apply.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00928590
C-09-032, EudraCT Number 2009-013178-42
No
Alcon Research
Alcon Research
Not Provided
Not Provided
Alcon Research
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP