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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: July 16, 2014
Last verified: July 2014

June 24, 2009
July 16, 2014
July 2009
November 2010   (final data collection date for primary outcome measure)
Adverse Events (AEs) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Adverse Events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
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 this 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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Open-angle Glaucoma
  • Ocular Hypertension
Drug: Travoprost/Timolol Maleate Fixed Combination solution
Other Names:
  • DuoTrav APS
  • DuoTrav (POLYQUAD-preserved)
Experimental: DuoTrav APS
Travoprost/Timolol Maleate Fixed Combination solution, 1 drop in the study eye(s) once daily, at 9 AM, for 12 months
Intervention: Drug: Travoprost/Timolol Maleate Fixed Combination solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
155
November 2010
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Willing and able to sign an informed consent document.
  • Open-angle glaucoma or ocular hypertension who would benefit from a fixed combination medication, in the opinion of the investigator.
  • Stable treatment of an IOP-lowering medication.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Pregnant, breastfeeding, or not using adequate birth control.
  • Best-corrected visual acuity (BCVA) worse than 55 ETDRS letters.
  • Other protocol-defined exclusion criteria may apply.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00928590
C-09-032, EudraCT Number 2009-013178-42
No
Alcon Research
Alcon Research
Not Provided
Study Director: Theresa Landry, Ph.D Alcon Research
Alcon Research
July 2014

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