Efficacy and Safety Study of Combigan and 0.5% Timoptic in Normal Tension Glaucoma

Study Overview
=================
Brief Summary
-----------------
Purpose To evaluate efficacy and safety of combigan(Brimonidine/Timolol) and 0.5% Timoptic (Timolol) ophthalmic solutions in normal tension glaucoma patients.

Detailed Description
-----------------
Normal tension glaucoma (NTG) is the major type of glaucoma in Korea. (over 90% of glaucoma type) Brimonidine (selective alpha 2 adrenergic agonist): neuroprotection effect by suppression of aqueous humor production and increasement of uveoscleral outflow Timolol (non selective beta blocker): suppression effect of aqueous humor production Combigan (fixed combination of brimonidine & timolol): more lowering effect of intraocular pressure and enhancing the compliance of glaucoma patients

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

Conditions
-----------------
Normal Tension Glaucoma

Intervention / Treatment
-----------------
* Drug: Brimonidine/Timolol mixed combination
* Drug: Timolol


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Timolol<br>non selective beta blocker, aqueous humor suppressant ophthalmic solution | Drug: Brimonidine/Timolol mixed combination<br>* Twice per day, 1 drop at each time<br>* Other names: Combigan;|
| Active Comparator: Combigan (Timolol/Brimonidine) combination drug<br>Brimonidine: alpha-2 agonist | Drug: Timolol<br>* Twice per day, 1 drop at each time<br>* Other names: Timoptic XE;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Normal tension glaucoma, Antiglaucoma ophthalmic solution, Brimonidine, Timolol, Combination drugs