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

Sponsor
Aristotle University Of Thessaloniki (Other)
Overall Status
Completed
CT.gov ID
NCT00981786
Collaborator
Alcon Research (Industry)
51
Enrollment
2
Arms
16
Actual Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Brimonidine/timolol fixed combination drops added to travoprost
  • Drug: Brinzolamide/timolol fixed combination drops added to travoprost
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
51 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Aug 1, 2009
Actual Primary Completion Date :
Sep 1, 2010
Actual Study Completion Date :
Dec 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Brinzolamide/Timolol therapy

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

Drug: Brimonidine/timolol fixed combination drops added to travoprost
twice daily administration
Other Names:
  • Combigan

    • Drug: Brinzolamide/timolol fixed combination drops added to travoprost
    twice daily dosing
    Other Names:
  • Azarga

    		•
    Active Comparator: Brimonidine/Timolol therapy

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

    Drug: Brimonidine/timolol fixed combination drops added to travoprost
    twice daily administration
    Other Names:
  • Combigan

    • Drug: Brinzolamide/timolol fixed combination drops added to travoprost
    twice daily dosing
    Other Names:
  • Azarga

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mean 24-hour intraocular pressure [3 months]

    Secondary Outcome Measures

    1. Fluctuation of 24-hour intraocular pressure [3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    29 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Aristotle University Of Thessaloniki
    • Alcon Research

    Investigators

    • Principal Investigator: Anastasios G Konstas, MD, PhD, Glaucoma Unit, 1st University Department of Ophthalmology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AGP Konstas, Professor in Ophthalmology, Aristotle University Of Thessaloniki
    ClinicalTrials.gov Identifier:
    NCT00981786
    Other Study ID Numbers:
    • A434
    First Posted:
    Sep 22, 2009
    Last Update Posted:
    Dec 17, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by AGP Konstas, Professor in Ophthalmology, Aristotle University Of Thessaloniki
    24-hour IOP control
    brinzolamide/timolol
    brimonidine/timolol
    travoprost
    Additional relevant MeSH terms:
    Glaucoma
    Timolol
    Brimonidine Tartrate
    Travoprost
    Brinzolamide

    Study Results

    No Results Posted as of Dec 17, 2020