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Study of Travatan and Cosopt in Primary Open-Angle Glaucoma or Ocular Hypertension

Primary Purpose

Open-angle Glaucoma, Ocular Hypertension

Status
Terminated
Phase
Phase 4
Locations
Portugal
Study Type
Interventional
Intervention
Travatan
Cosopt
Placebo (Timolol Vehicle)
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open-angle Glaucoma

Eligibility Criteria

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

Inclusion Criteria:

  • Patient with open-angle glaucoma or ocular hypertension

Exclusion Criteria:

  • By Age

Sites / Locations

  • Coimbra

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Travatan

Cosopt

Arm Description

Travatan: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s)

treatment period of 6 weeks with Cosopt (dorzolamide 20 mg/ml and timolol maleate 5 mg/ml eye drops, solution) twice daily at 08:00 and 20:00 in the affected eye(s)

Outcomes

Primary Outcome Measures

Intaocular Pressure (IOP) Mean Change After 6 Weeks of Treatment
IOP measured at week 6 minus IOP measured at baseline

Secondary Outcome Measures

Full Information

First Posted
May 8, 2007
Last Updated
April 7, 2012
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00471068
Brief Title
Study of Travatan and Cosopt in Primary Open-Angle Glaucoma or Ocular Hypertension
Official Title
Study of Travatan and Cosopt in Primary Open-Angle Glaucoma or Ocular Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Terminated
Why Stopped
Question raised by Ethics Committee
Study Start Date
March 2007 (undefined)
Primary Completion Date
August 2008 (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 compare the efficacy and safety in patients treated with travoprost versus dorzolamide/timolol maleate combination in patients with open-angle glaucoma or ocular hypertension

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Travatan
Arm Type
Experimental
Arm Description
Travatan: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s)
Arm Title
Cosopt
Arm Type
Active Comparator
Arm Description
treatment period of 6 weeks with Cosopt (dorzolamide 20 mg/ml and timolol maleate 5 mg/ml eye drops, solution) twice daily at 08:00 and 20:00 in the affected eye(s)
Intervention Type
Drug
Intervention Name(s)
Travatan
Intervention Description
Travatan: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s)
Intervention Type
Drug
Intervention Name(s)
Cosopt
Intervention Description
treatment period of 6 weeks with Cosopt (dorzolamide 20 mg/ml and timolol maleate 5 mg/ml eye drops, solution) twice daily at 08:00 and 20:00 in the affected eye(s)
Intervention Type
Drug
Intervention Name(s)
Placebo (Timolol Vehicle)
Intervention Description
Travatan group: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s)
Primary Outcome Measure Information:
Title
Intaocular Pressure (IOP) Mean Change After 6 Weeks of Treatment
Description
IOP measured at week 6 minus IOP measured at baseline
Time Frame
At week 0 and week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with open-angle glaucoma or ocular hypertension Exclusion Criteria: By Age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Grau
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Coimbra
City
Coimbra
ZIP/Postal Code
3000354
Country
Portugal

12. IPD Sharing Statement

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Study of Travatan and Cosopt in Primary Open-Angle Glaucoma or Ocular Hypertension

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