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
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
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
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
NCT ID
NCT01084902
First Posted
March 10, 2010
Last Updated
March 10, 2010
Sponsor
Peking University First Hospital
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
Learn more about this trial
Efficacy Comparison of Xalatan and Azopt on POAG and OH
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