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A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension

Primary Purpose

Open-Angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution
Latanoprost 0.005% Ophthalmic Solution (XALATAN)
Timolol 0.5% Ophthalmic Solution
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 focused on measuring Open-angle, glaucoma, ocular, hypertension

Eligibility Criteria

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

Inclusion Criteria: 18 years or older. Diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension. Mean intraocular pressure (IOP) in at least one eye greater than 21 mmHg and less than or equal to 36 mmHg at screening visit. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Pregnant History of chronic or recurrent severe inflammatory eye disease. History of ocular infection or ocular inflammation within the past three months in either eye. Other protocol-defined exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Travoprost/Timolol

    Xalatan + Timolol 0.5%

    Arm Description

    One drop Travoprost 0.004%/Timolol 0.5% in the study eye(s) each morning at 8 a.m. and one drop Timolol vehicle in the study eye(s) each evening at 8 p.m. for 3 months

    One drop Timolol 0.5% in the study eye(s) each morning at 8 a.m. and one drop Xalatan in the study eye(s) each evening at 8 p.m. for 3 months

    Outcomes

    Primary Outcome Measures

    Mean Intraocular Pressure (IOP) Change at 3 Months from Baseline

    Secondary Outcome Measures

    Full Information

    First Posted
    February 17, 2006
    Last Updated
    February 11, 2012
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00293800
    Brief Title
    A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2004 (undefined)
    Primary Completion Date
    December 2005 (Actual)
    Study Completion Date
    December 2005 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of the study is to evaluate the safety and effectiveness of an investigational glaucoma therapy 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
    Keywords
    Open-angle, glaucoma, ocular, hypertension

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    173 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Travoprost/Timolol
    Arm Type
    Experimental
    Arm Description
    One drop Travoprost 0.004%/Timolol 0.5% in the study eye(s) each morning at 8 a.m. and one drop Timolol vehicle in the study eye(s) each evening at 8 p.m. for 3 months
    Arm Title
    Xalatan + Timolol 0.5%
    Arm Type
    Active Comparator
    Arm Description
    One drop Timolol 0.5% in the study eye(s) each morning at 8 a.m. and one drop Xalatan in the study eye(s) each evening at 8 p.m. for 3 months
    Intervention Type
    Drug
    Intervention Name(s)
    Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution
    Intervention Description
    Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension
    Intervention Type
    Drug
    Intervention Name(s)
    Latanoprost 0.005% Ophthalmic Solution (XALATAN)
    Other Intervention Name(s)
    XALATAN
    Intervention Description
    Commercially marketed ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension
    Intervention Type
    Drug
    Intervention Name(s)
    Timolol 0.5% Ophthalmic Solution
    Intervention Description
    Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension
    Intervention Type
    Other
    Intervention Name(s)
    Timolol Vehicle
    Intervention Description
    Placebo
    Primary Outcome Measure Information:
    Title
    Mean Intraocular Pressure (IOP) Change at 3 Months from Baseline
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18 years or older. Diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension. Mean intraocular pressure (IOP) in at least one eye greater than 21 mmHg and less than or equal to 36 mmHg at screening visit. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Pregnant History of chronic or recurrent severe inflammatory eye disease. History of ocular infection or ocular inflammation within the past three months in either eye. Other protocol-defined exclusion criteria may apply.

    12. IPD Sharing Statement

    Learn more about this trial

    A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension

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