Efficacy Comparison of Xalatan and Azopt on POAG and OH

NCT ID: NCT01084902

Last Updated: 2010-03-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2010-12-31

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.

Conditions

Ocular Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

latnoprost

once daily

Group Type: EXPERIMENTAL

Latanoprost

Intervention Type: DRUG

once daily

Brinzolamide

two times daily

Group Type: ACTIVE_COMPARATOR

Brinzolamide

Intervention Type: DRUG

Two times daily

Interventions

Latanoprost

once daily

Intervention Type: DRUG

Brinzolamide

Two times daily

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University First Hospital

OTHER

Sponsor Role: lead

Responsible Party

Peking University First Hospital

Principal Investigators

Yingzi Pan, doctor

Role: STUDY_CHAIR

Peking University First Hospital

Other Identifiers

PKU1H

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PKU1H001

Identifier Type: -

Identifier Source: org_study_id