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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01446497

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Normal Tension Glaucoma	Drug: Brimonidine/Timolol mixed combination Drug: Timolol	Phase 4

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Aug 1, 2011

Anticipated Study Completion Date :

Aug 1, 2012

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Timolol

non selective beta blocker, aqueous humor suppressant ophthalmic solution

Drug: Brimonidine/Timolol mixed combination

Twice per day, 1 drop at each time

Other Names:

Combigan

Active Comparator: Combigan (Timolol/Brimonidine) combination drug

Brimonidine: alpha-2 agonist

Drug: Timolol

Twice per day, 1 drop at each time

Other Names:

Timoptic XE

Outcome Measures

Primary Outcome Measures

Change from baseline in intraocular pressure at 12 weeks [12 weeks after the initial treatment]
Intraocular pressure (IOP) check by Goldmann applanation tonometry with topical anesthetic eyedrop

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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