Efficacy Comparison of Xalatan and Azopt on POAG and OH

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01084902
• Other study ID #: PKU1H001
• Secondary ID: PKU1H
• Status: Active, not recruiting
• Phase: N/A
• First received: March 10, 2010
• Last updated: March 10, 2010
• Start date: February 2010
• Est. completion date: December 2010

Study information

• Verified date: March 2010
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: December 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Ocular Hypertension

Intervention

Drug:
• Latanoprost
once daily
• Brinzolamide
Two times daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 2 weeks, 4 weeks	No