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

Phase 4

• Conditions: Normal Tension Glaucoma
• Interventions: Drug: Brimonidine/Timolol mixed combination; Drug: Timolol

• Registration Number: NCT01446497
• Lead Sponsor: Seoul National University Hospital

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

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2011-08
• Study First Submitted: 2011-09-25
• Status Verified: 2011-10
• Study First Submitted QC: 2011-10-03
• Last Update Submitted: 2011-10-03
• Study First Posted: 2011-10-05
• Last Update Posted: 2011-10-05
• Study Completion: 2012-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• over 18 years old
• baseline IOP under 22 mmHg,both anterior chamber angle > Grade 3~4 by Shaffer grading system

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Timolol	Brimonidine/Timolol mixed combination	non selective beta blocker, aqueous humor suppressant ophthalmic solution
Combigan (Timolol/Brimonidine) combination drug	Timolol	Brimonidine: alpha-2 agonist

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of