Efficacy Comparison of Xalatan and Azopt on POAG and OH

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Peking University First Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Peking University First Hospital
ClinicalTrials.gov Identifier:
NCT01084902
First received: March 10, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted

March 10, 2010
March 10, 2010
February 2010
September 2010   (final data collection date for primary outcome measure)
Intraocular Pressure [ Time Frame: Baseline, 2 weeks, 4 weeks ] [ Designated as safety issue: No ]
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.
Same as current
No Changes Posted
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Efficacy Comparison of Xalatan and Azopt on POAG and OH
Comparison of the Effects of Latanoprost(0.005%) and Brinzolamide(1.0%) on Intraocular Pressure in Primary Open-angle Glaucoma and Ocular Hypertension

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Ocular Hypertension
  • Drug: Latanoprost
    once daily
  • Drug: Brinzolamide
    Two times daily
  • Experimental: latnoprost
    once daily
    Intervention: Drug: Latanoprost
  • Active Comparator: Brinzolamide
    two times daily
    Intervention: Drug: Brinzolamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
130
December 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01084902
PKU1H001, PKU1H
Not Provided
Yingzi PAN/Professor of Ophthalmological Department, Peking University First Hospital
Peking University First Hospital
Not Provided
Study Chair: Yingzi Pan, doctor Peking University First Hospital
Peking University First Hospital
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP