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Safety and Intraocular Pressure (IOP) Lowering Efficacy of Low Dose Travoprost

Primary Purpose

Open-angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Travoprost ophthalmic solution, 0.0008%
Travoprost ophthalmic solution, 0.001%
Travoprost ophthalmic solution, 0.0012%
TRAVATAN
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:

  • Patients 18 years of age or older, either sex or race with open-angle glaucoma or confirmed ocular hypertension
  • Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

  • Age related
  • Other protocol-defined exclusion criteria may apply

Sites / Locations

  • Contact Alcon Call Center at 1-888-451-3937

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

Travoprost 0.0008%

Travoprost 0.001%

Travoprost 0.0012%

TRAVATAN + Vehicle

Vehicle

Arm Description

Travoprost ophthalmic solution, 0.0008%, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks

Travoprost ophthalmic solution, 0.001%, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks

Travoprost ophthalmic solution, 0.0012%, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks

TRAVATAN, one drop in study eye(s) once daily (8 PM), and Vehicle, one drop in study eye(s) once daily (8 AM), for two weeks

Vehicle, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks

Outcomes

Primary Outcome Measures

Mean Intraocular Pressure

Secondary Outcome Measures

Full Information

First Posted
February 29, 2008
Last Updated
December 4, 2012
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00637130
Brief Title
Safety and Intraocular Pressure (IOP) Lowering Efficacy of Low Dose Travoprost
Official Title
Safety and IOP Lowering Efficacy of Low Dose Travoprost Ophthalmic Solutions Dosed BID Compared to TRAVATAN® in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
January 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
The purpose of this study is to compare the safety and IOP-lowering efficacy of various low dose travoprost formulations 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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Travoprost 0.0008%
Arm Type
Experimental
Arm Description
Travoprost ophthalmic solution, 0.0008%, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks
Arm Title
Travoprost 0.001%
Arm Type
Experimental
Arm Description
Travoprost ophthalmic solution, 0.001%, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks
Arm Title
Travoprost 0.0012%
Arm Type
Experimental
Arm Description
Travoprost ophthalmic solution, 0.0012%, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks
Arm Title
TRAVATAN + Vehicle
Arm Type
Active Comparator
Arm Description
TRAVATAN, one drop in study eye(s) once daily (8 PM), and Vehicle, one drop in study eye(s) once daily (8 AM), for two weeks
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Travoprost ophthalmic solution, 0.0008%
Intervention Type
Drug
Intervention Name(s)
Travoprost ophthalmic solution, 0.001%
Intervention Type
Drug
Intervention Name(s)
Travoprost ophthalmic solution, 0.0012%
Intervention Type
Drug
Intervention Name(s)
TRAVATAN
Intervention Type
Other
Intervention Name(s)
Vehicle
Primary Outcome Measure Information:
Title
Mean Intraocular Pressure
Time Frame
Up to 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients 18 years of age or older, either sex or race with open-angle glaucoma or confirmed ocular hypertension Other protocol-defined inclusion criteria may apply Exclusion Criteria: Age related Other protocol-defined exclusion criteria may apply
Facility Information:
Facility Name
Contact Alcon Call Center at 1-888-451-3937
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States

12. IPD Sharing Statement

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Safety and Intraocular Pressure (IOP) Lowering Efficacy of Low Dose Travoprost

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