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
  Purpose

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 Intervention
Ocular Hypertension
Drug: Latanoprost
Drug: Brinzolamide

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Peking University First Hospital:

Primary Outcome Measures:
  • 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.


Enrollment: 130
Study Start Date: February 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: latnoprost
once daily
Drug: Latanoprost
once daily
Active Comparator: Brinzolamide
two times daily
Drug: Brinzolamide
Two times daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01084902

Sponsors and Collaborators
Peking University First Hospital
Investigators
Study Chair: Yingzi Pan, doctor Peking University First Hospital
  More Information

No publications provided

Responsible Party: Yingzi PAN/Professor of Ophthalmological Department, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT01084902     History of Changes
Other Study ID Numbers: PKU1H001, PKU1H
Study First Received: March 10, 2010
Last Updated: March 10, 2010
Health Authority: China: Food and Drug Administration

Keywords provided by Peking University First Hospital:
POAG
OH
Xalatan
Azopt
Primary Open Angle Study

Additional relevant MeSH terms:
Hypertension
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Latanoprost
Brinzolamide
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2014