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DuoTrav® Eye Drops As Replacement Therapy Program

Primary Purpose

Open-angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
DuoTrav
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open-angle Glaucoma focused on measuring Glaucoma, IOP, DuoTrav

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with OAG or OH for whom single agent therapy provides insufficient intraocular pressure reduction

Exclusion Criteria:

  • None

Sites / Locations

  • Contact Alcon for Trial Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

DuoTrav

Outcomes

Primary Outcome Measures

Intra Ocular Pressure

Secondary Outcome Measures

Full Information

First Posted
January 23, 2009
Last Updated
September 18, 2012
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00828906
Brief Title
DuoTrav® Eye Drops As Replacement Therapy Program
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the effectiveness of DuoTrav Eye Drops in gaining or maintaining control of target Intraocular Pressures (tIOP) in patients diagnosed with, and being treated for, open-angle glaucoma (OAG) or ocular hypertension (OH).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-angle Glaucoma, Ocular Hypertension
Keywords
Glaucoma, IOP, DuoTrav

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
DuoTrav
Intervention Type
Drug
Intervention Name(s)
DuoTrav
Intervention Description
DuoTrav Eye Drops
Primary Outcome Measure Information:
Title
Intra Ocular Pressure
Time Frame
visit 1, Visits 2-3, Visits 6-8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with OAG or OH for whom single agent therapy provides insufficient intraocular pressure reduction Exclusion Criteria: None
Facility Information:
Facility Name
Contact Alcon for Trial Locations
City
Bejing
Country
China

12. IPD Sharing Statement

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DuoTrav® Eye Drops As Replacement Therapy Program

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