Normal Tension Glaucoma Clinical Trial
Official title:
Randomized, Multicenter, Open-label, Parallel Group Study to Evaluate Efficacy and Safety of Combigan(Brimonidine/Timolol) and 0.5% Timoptic(Timolol) Ophthalmic Solutions in Normal Tension Glaucoma Patients
Purpose To evaluate efficacy and safety of combigan(Brimonidine/Timolol) and 0.5% Timoptic (Timolol) ophthalmic solutions in normal tension glaucoma patients.
Status | Recruiting |
Enrollment | 22 |
Est. completion date | August 2012 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - over 18 years old - baseline IOP under 22 mmHg,both anterior chamber angle > Grade 3~4 by Shaffer grading system Exclusion Criteria: - IOP over 22 mmHg by Goldmann applanation tonometer - other types of glaucoma except open angle - other IOP lowering treatment - chronic or recurrent Hx. of ocular inflammation - using contact lens - any other ocular disease that could affect visual field examination (diabetic retinopathy, macular disease, uveitis, scleritis, optic neuritis, anterior ischemic optic neuropathy) - intraocular or glaucoma surgery within 6 months - Hx. of allergic reaction to timolol or brimonidine - bronchial asthma - moderate to severe chronic obstructive pulmonary disease - heart failure - 2~3 degree A-V block, - MAO inhibitor use - anti depressant use - untreated pheochromocytoma - pregnant |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in intraocular pressure at 12 weeks | Intraocular pressure (IOP) check by Goldmann applanation tonometry with topical anesthetic eyedrop | 12 weeks after the initial treatment | Yes |
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