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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01446497

Enrollment

Registered

2011-10-05

Start date

2010-10-31

Completion date

2012-08-31

Last updated

2011-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal Tension Glaucoma

Keywords

Normal tension glaucoma, Antiglaucoma ophthalmic solution, Brimonidine, Timolol, Combination drugs

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

Interventions

DRUGBrimonidine/Timolol mixed combination

Twice per day, 1 drop at each time

DRUGTimolol

Twice per day, 1 drop at each time

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

South Korea

Contacts

Primary ContactKi Ho Park, M.D., Ph.D.

kihopark@snu.ac.kr+82-2-2072-2438

Backup ContactJae Hoon Jeong, M.D.

j2h23@hanmail.net+82-2-2072-2438

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026