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Efficacy Comparison of Xalatan and Azopt on POAG and OH

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01084902
Recruitment Status : Unknown
Verified March 2010 by Peking University First Hospital.
Recruitment status was:  Active, not recruiting
First Posted : March 11, 2010
Last Update Posted : March 11, 2010
Information provided by:
Peking University First Hospital

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.

Condition or disease Intervention/treatment Phase
Ocular Hypertension Drug: Latanoprost Drug: Brinzolamide Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2010
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : December 2010

Arm Intervention/treatment
Experimental: latnoprost
once daily
Drug: Latanoprost
once daily

Active Comparator: Brinzolamide
two times daily
Drug: Brinzolamide
Two times daily

Primary Outcome Measures :
  1. Intraocular Pressure [ Time Frame: Baseline, 2 weeks, 4 weeks ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01084902

Sponsors and Collaborators
Peking University First Hospital
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Study Chair: Yingzi Pan, doctor Peking University First Hospital
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Responsible Party: Yingzi PAN/Professor of Ophthalmological Department, Peking University First Hospital Identifier: NCT01084902    
Other Study ID Numbers: PKU1H001
PKU1H ( Other Grant/Funding Number: IIR )
First Posted: March 11, 2010    Key Record Dates
Last Update Posted: March 11, 2010
Last Verified: March 2010
Keywords provided by Peking University First Hospital:
Primary Open Angle Study
Additional relevant MeSH terms:
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Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Antihypertensive Agents
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action