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

Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Normal Tension Glaucoma

Intervention: Brimonidine/Timolol mixed combination (Drug); Timolol (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Seoul National University Hospital

Official(s) and/or principal investigator(s):
Ki Ho Park, M.D, Ph.D., Principal Investigator, Affiliation: Seoul National University Hospital

Overall contact:
Ki Ho Park, M.D., Ph.D., Phone: +82-2-2072-2438, Ext: 3172, Email: kihopark@snu.ac.kr


Purpose To evaluate efficacy and safety of combigan(Brimonidine/Timolol) and 0. 5% Timoptic (Timolol) ophthalmic solutions in normal tension glaucoma patients.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change from baseline in intraocular pressure at 12 weeks

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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Ki Ho Park, M.D., Ph.D., Phone: +82-2-2072-2438, Ext: 3172, Email: kihopark@snu.ac.kr

Seoul National University Hospital, Seoul 110-744, Korea, Republic of; Recruiting
Ki Ho Park, M.D., Ph.D., Phone: +82-2-2072-2438, Ext: 3172, Email: kihopark@snu.ac.kr
Jae Hoon Jeong, M.D., Phone: +82-2-2072-2438, Ext: 3110, Email: j2h23@hanmali.net
Additional Information

Starting date: October 2010
Last updated: October 3, 2011

Page last updated: August 23, 2015

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