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24-Hour Intraocular Pressure With Brinzolamide/Timolol Versus Brimonidine/Timolol

Primary Purpose

Glaucoma

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Brimonidine/timolol fixed combination drops added to travoprost
Brinzolamide/timolol fixed combination drops added to travoprost
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring 24-hour IOP control, brinzolamide/timolol, brimonidine/timolol, travoprost

Eligibility Criteria

29 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient has open-angle glaucoma and is older than 29 years
  • Patients should exhibit typical disc, or field changes and an untreated morning IOP greater than 25 mm Hg
  • Patients are treated for at least 3 months with travoprost and should have demonstrated at least a 20% morning IOP reduction
  • Patient deemed by PI to require adjunctive therapy to obtain desired target IOP
  • Patient should exhibit IOP greater than 18 mm Hg on travoprost monotherapy (2 separate IOP readings at 10:00)
  • Patient has mild to moderate glaucoma (field loss more than 16 dB; cupping 0.8 or less)
  • Distance best corrected Snellen visual acuity at least 0.1
  • No contraindications to travoprost, brimonidine, brinzolamide and β-blockers
  • No history of lack of response (<10% morning IOP reduction) to any medication
  • Patient can understand the instructions and adhere to medications

Exclusion Criteria:

  • Female patient of childbearing potential or lactating mother
  • History of trauma, inflammation, surgery
  • History of past use of steroids (within 2 months), severe dry eyes and use of contact lenses
  • Signs of ocular infection, except blepharitis
  • Evidence of corneal abnormality that may affect IOP measurements etc
  • Closed angle
  • History of non-compliance

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Brinzolamide/Timolol therapy

    Brimonidine/Timolol therapy

    Arm Description

    Chronic therapy for 3 months with brinzolamide/timolol drops given twice daily added to travoprost drops

    Chronic therapy for 3 months with brimonidine/timolol drops given twice daily added to travoprost drops

    Outcomes

    Primary Outcome Measures

    Mean 24-hour intraocular pressure

    Secondary Outcome Measures

    Fluctuation of 24-hour intraocular pressure

    Full Information

    First Posted
    September 16, 2009
    Last Updated
    December 16, 2020
    Sponsor
    Aristotle University Of Thessaloniki
    Collaborators
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00981786
    Brief Title
    24-Hour Intraocular Pressure With Brinzolamide/Timolol Versus Brimonidine/Timolol
    Official Title
    Quality of 24-hour Intraocular Pressure Control Obtained With the Brinzolamide/Timolol Fixed Combination Compared With the Brimonidine/Timolol Fixed Combination When Added to Travoprost Monotherapy in Subjects With Open-angle Glaucoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2009 (Actual)
    Primary Completion Date
    September 2010 (Actual)
    Study Completion Date
    December 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Aristotle University Of Thessaloniki
    Collaborators
    Alcon Research

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The proposed crossover study will compare for the first time the quality of 24-hour intraocular pressure control with the combination of travoprost and brinzolamide/timolol compared with travoprost and brimonidine/timolol in glaucoma patients insufficiently controlled with travoprost. This comparison may determine the real efficacy of the two fixed combinations when added to the prostaglandin. The design of the proposed study should facilitate a better understanding of the role of these medications in glaucoma management.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glaucoma
    Keywords
    24-hour IOP control, brinzolamide/timolol, brimonidine/timolol, travoprost

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    51 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Brinzolamide/Timolol therapy
    Arm Type
    Active Comparator
    Arm Description
    Chronic therapy for 3 months with brinzolamide/timolol drops given twice daily added to travoprost drops
    Arm Title
    Brimonidine/Timolol therapy
    Arm Type
    Active Comparator
    Arm Description
    Chronic therapy for 3 months with brimonidine/timolol drops given twice daily added to travoprost drops
    Intervention Type
    Drug
    Intervention Name(s)
    Brimonidine/timolol fixed combination drops added to travoprost
    Other Intervention Name(s)
    Combigan
    Intervention Description
    twice daily administration
    Intervention Type
    Drug
    Intervention Name(s)
    Brinzolamide/timolol fixed combination drops added to travoprost
    Other Intervention Name(s)
    Azarga
    Intervention Description
    twice daily dosing
    Primary Outcome Measure Information:
    Title
    Mean 24-hour intraocular pressure
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Fluctuation of 24-hour intraocular pressure
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    29 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient has open-angle glaucoma and is older than 29 years Patients should exhibit typical disc, or field changes and an untreated morning IOP greater than 25 mm Hg Patients are treated for at least 3 months with travoprost and should have demonstrated at least a 20% morning IOP reduction Patient deemed by PI to require adjunctive therapy to obtain desired target IOP Patient should exhibit IOP greater than 18 mm Hg on travoprost monotherapy (2 separate IOP readings at 10:00) Patient has mild to moderate glaucoma (field loss more than 16 dB; cupping 0.8 or less) Distance best corrected Snellen visual acuity at least 0.1 No contraindications to travoprost, brimonidine, brinzolamide and β-blockers No history of lack of response (<10% morning IOP reduction) to any medication Patient can understand the instructions and adhere to medications Exclusion Criteria: Female patient of childbearing potential or lactating mother History of trauma, inflammation, surgery History of past use of steroids (within 2 months), severe dry eyes and use of contact lenses Signs of ocular infection, except blepharitis Evidence of corneal abnormality that may affect IOP measurements etc Closed angle History of non-compliance
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anastasios G Konstas, MD, PhD
    Organizational Affiliation
    Glaucoma Unit, 1st University Department of Ophthalmology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    24-Hour Intraocular Pressure With Brinzolamide/Timolol Versus Brimonidine/Timolol

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