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Efficacy Comparison of Xalatan and Azopt on POAG and OH

Primary Purpose

Ocular Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Latanoprost
Brinzolamide
Sponsored by
Peking University First Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ocular Hypertension focused on measuring POAG, OH, Xalatan, Azopt, Primary Open Angle Study

Eligibility Criteria

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

Inclusion Criteria:

  1. Diagnosed with POAG or OHT
  2. Older than 18 years, either sex
  3. With IOP≤30mmHg in both eyes and with IOP>21mmHg in either eye after washout
  4. Understand the study instructions and are willing to attend at all follow-up appointments
  5. Be willing to comply with study medication use
  6. Ready for written informed consent

Exclusion Criteria:

  1. Visual field defects within the central 10°
  2. Absence of vision in one eye
  3. History of hypersensitivity to any components of the study medications
  4. Contraindications to carbonic anhydrase inhibitors or prostaglandins
  5. History of ocular herpetic disease, uveitis, or cystoid macular edema
  6. Ocular history of trauma, inflammation, surgery or use of corticosteroids (within 2 months)
  7. History of ocular laser therapy within 3 months
  8. Severe dry eyes
  9. Signs of ocular infection, except blepharitis
  10. Corneal abnormality that may affect IOP measurements
  11. Unwilling to accept the risk for hyperchromia of the iris or development of hypertrichosis
  12. Pregnant females or lactating mothers

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    latnoprost

    Brinzolamide

    Arm Description

    once daily

    two times daily

    Outcomes

    Primary Outcome Measures

    Intraocular Pressure
    Three separate measurements will be taken for each eye. And mean result will be taken if the difference between measurements is within 2 mmHg , or use the median if the difference between measurements is greater than 3 mmHg.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 10, 2010
    Last Updated
    March 10, 2010
    Sponsor
    Peking University First Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01084902
    Brief Title
    Efficacy Comparison of Xalatan and Azopt on POAG and OH
    Official Title
    Comparison of the Effects of Latanoprost(0.005%) and Brinzolamide(1.0%) on Intraocular Pressure in Primary Open-angle Glaucoma and Ocular Hypertension
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2010
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2010 (undefined)
    Primary Completion Date
    September 2010 (Anticipated)
    Study Completion Date
    December 2010 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Peking University First Hospital

    4. Oversight

    5. Study Description

    Brief Summary
    Prostaglandin analogs (PGAs) represent a new class of active ocular hypotensive agents and possess a unique mechanism of action. Many studies suggested that 0.005% Latanoprost was more effective and safer than other anti-glaucoma medications, such as beta-blockers. It has also been found to be more effective than other class of anti-glaucoma medications such as carbonic anhydrase inhibitors and alpha agonists. However data on such comparison is lacking in Chinese patients. So it is necessary to increase China experience and get clinical data from China. Besides latanoprost, brinzolamide is known as one of the other ocular hypotensive agents with less systemic adverse effects, therefore it is selected as the controlled medication of this study. The administration phase will be 4 weeks because it is long enough to compare both efficacy and safety of the study drugs and accounting for following-up conditions in China, it will be easier for the investigators to get enough subjects in a limited stage if the observation time is shorter. Before treatment with the study drugs, any previous glaucoma drugs will be washed out. The minimum washout periods are 5 days for cholinergic agonists, 1 week for adrenergic agonists, 3 weeks for adrenergic β receptor blockers and 4 weeks for PGAS. After washout, the patients will be randomised send to two parallel study groups: one group will receive latanoprost 0.005% once daily in the evening, the other group receive 1.0% Brinzolamide twice daily. Randomization will be obtained using a list of random numbers .During the study there will be four visits: screening, baseline, 2 weeks, and 4 weeks of treatment. The IOP will be measured with a Goldmann tonometer at 8 am for each visit. The tonometry will be performed before the administration of the dose of the day in patients treated with Brinzolamide. Three separate measurements will be taken for each eye and the mean of the three measurements will be used in the statistical analysis. Best corrected visual acuity and refraction will be determined and a slit lamp examination, ophthalmoscopy will be performed at all visits.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ocular Hypertension
    Keywords
    POAG, OH, Xalatan, Azopt, Primary Open Angle Study

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    130 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    latnoprost
    Arm Type
    Experimental
    Arm Description
    once daily
    Arm Title
    Brinzolamide
    Arm Type
    Active Comparator
    Arm Description
    two times daily
    Intervention Type
    Drug
    Intervention Name(s)
    Latanoprost
    Intervention Description
    once daily
    Intervention Type
    Drug
    Intervention Name(s)
    Brinzolamide
    Intervention Description
    Two times daily
    Primary Outcome Measure Information:
    Title
    Intraocular Pressure
    Description
    Three separate measurements will be taken for each eye. And mean result will be taken if the difference between measurements is within 2 mmHg , or use the median if the difference between measurements is greater than 3 mmHg.
    Time Frame
    Baseline, 2 weeks, 4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosed with POAG or OHT Older than 18 years, either sex With IOP≤30mmHg in both eyes and with IOP>21mmHg in either eye after washout Understand the study instructions and are willing to attend at all follow-up appointments Be willing to comply with study medication use Ready for written informed consent Exclusion Criteria: Visual field defects within the central 10° Absence of vision in one eye History of hypersensitivity to any components of the study medications Contraindications to carbonic anhydrase inhibitors or prostaglandins History of ocular herpetic disease, uveitis, or cystoid macular edema Ocular history of trauma, inflammation, surgery or use of corticosteroids (within 2 months) History of ocular laser therapy within 3 months Severe dry eyes Signs of ocular infection, except blepharitis Corneal abnormality that may affect IOP measurements Unwilling to accept the risk for hyperchromia of the iris or development of hypertrichosis Pregnant females or lactating mothers
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yingzi Pan, doctor
    Organizational Affiliation
    Peking University First Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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    Efficacy Comparison of Xalatan and Azopt on POAG and OH

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