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Efficacy of Travoprost/Timolol for Uncontrolled Intraocular Pressure

Primary Purpose

Open Angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Beta-blocker monotherapy
Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution
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, Intraocular Pressure

Eligibility Criteria

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

Inclusion Criteria:

  • Have a clinical diagnosis of either open angle glaucoma or ocular hypertension.
  • Currently on beta-blocker monotherapy (for >30 days) and would benefit, in the opinion of the investigator, from further intraocular pressure (lOP) reduction.
  • Have a mean baseline lOP of >18 mmHg and <32 mmHg in at least one eye.
  • Must be able to understand and sign an Informed Consent form.
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Use of medication excluded by the protocol.
  • Diseases, illnesses, infections, or ocular abnormalities excluded by the protocol.
  • Ocular surgeries or procedures excluded by the protocol.
  • Best-corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to 20/80 Snellen, 0.60 logMAR or 0.25 decimal).
  • Hypersensitivity to prostaglandin analogues or any component of the study medications in the opinion of the investigator.
  • Women of childbearing potential if pregnant, test positive for pregnancy at Screening visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
  • Other protocol-specified exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    DuoTrav

    Beta-blocker

    Arm Description

    Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution, 1 drop instilled in the study eye once daily (evening) for 8 weeks.

    Participant's current beta-blocker monotherapy, 1 drop instilled in the study eye twice daily (morning and evening) for 4 weeks, followed by travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution, 1 drop instilled in the study eye once daily (evening) for 4 additional weeks.

    Outcomes

    Primary Outcome Measures

    Least Squares Mean Intraocular Pressure (IOP) at 8AM in the Study Eye
    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis.

    Secondary Outcome Measures

    Mean Change From Baseline in IOP (8AM) at Week 4 in the Study Eye
    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in mmHg. A negative change indicates an improvement. One eye (study eye) contributed to the analysis.
    Percentage Change From Baseline in IOP (8AM) at Week 4 in the Study Eye
    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in mmHg. A more negative percent change from baseline indicates a greater amount of improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.

    Full Information

    First Posted
    December 2, 2013
    Last Updated
    June 27, 2016
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02003391
    Brief Title
    Efficacy of Travoprost/Timolol for Uncontrolled Intraocular Pressure
    Official Title
    Prospective, Randomized, Multi-Center Study to Evaluate the Efficacy and Tolerability of DuoTrav® in Patients Previously Uncontrolled on a Beta-blocker
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2013 (undefined)
    Primary Completion Date
    May 2015 (Actual)
    Study Completion Date
    May 2015 (Actual)

    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 demonstrate superior intraocular pressure (IOP) control with travoprost 0.004% / timolol 0.5% compared to beta-blocker monotherapy in participants 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, Intraocular Pressure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    157 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    DuoTrav
    Arm Type
    Experimental
    Arm Description
    Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution, 1 drop instilled in the study eye once daily (evening) for 8 weeks.
    Arm Title
    Beta-blocker
    Arm Type
    Active Comparator
    Arm Description
    Participant's current beta-blocker monotherapy, 1 drop instilled in the study eye twice daily (morning and evening) for 4 weeks, followed by travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution, 1 drop instilled in the study eye once daily (evening) for 4 additional weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Beta-blocker monotherapy
    Intervention Description
    Per participant's current prescribed therapy
    Intervention Type
    Drug
    Intervention Name(s)
    Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution
    Other Intervention Name(s)
    DUOTRAV®
    Primary Outcome Measure Information:
    Title
    Least Squares Mean Intraocular Pressure (IOP) at 8AM in the Study Eye
    Description
    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis.
    Time Frame
    Week 4
    Secondary Outcome Measure Information:
    Title
    Mean Change From Baseline in IOP (8AM) at Week 4 in the Study Eye
    Description
    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in mmHg. A negative change indicates an improvement. One eye (study eye) contributed to the analysis.
    Time Frame
    Baseline (Day 0), Week 4
    Title
    Percentage Change From Baseline in IOP (8AM) at Week 4 in the Study Eye
    Description
    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in mmHg. A more negative percent change from baseline indicates a greater amount of improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.
    Time Frame
    Baseline (Day 0), Week 4

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Have a clinical diagnosis of either open angle glaucoma or ocular hypertension. Currently on beta-blocker monotherapy (for >30 days) and would benefit, in the opinion of the investigator, from further intraocular pressure (lOP) reduction. Have a mean baseline lOP of >18 mmHg and <32 mmHg in at least one eye. Must be able to understand and sign an Informed Consent form. Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Use of medication excluded by the protocol. Diseases, illnesses, infections, or ocular abnormalities excluded by the protocol. Ocular surgeries or procedures excluded by the protocol. Best-corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to 20/80 Snellen, 0.60 logMAR or 0.25 decimal). Hypersensitivity to prostaglandin analogues or any component of the study medications in the opinion of the investigator. Women of childbearing potential if pregnant, test positive for pregnancy at Screening visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study. Other protocol-specified exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Clinical Project Lead GCRA, Pharma
    Organizational Affiliation
    Alcon Research
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28239491
    Citation
    Lerner SF, Park KH, Hubatsch DA, Erichev V, Paczka JA, Roberts TV. Efficacy and Tolerability of Travoprost 0.004%/Timolol 0.5% Fixed-Dose Combination for the Treatment of Primary Open-Angle Glaucoma or Ocular Hypertension Inadequately Controlled with Beta-Blocker Monotherapy. J Ophthalmol. 2017;2017:1917570. doi: 10.1155/2017/1917570. Epub 2017 Jan 23.
    Results Reference
    derived

    Learn more about this trial

    Efficacy of Travoprost/Timolol for Uncontrolled Intraocular Pressure

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