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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01446497
Other study ID # H-1008-059-327
Secondary ID KHP01
Status Recruiting
Phase Phase 4
First received September 25, 2011
Last updated October 3, 2011
Start date October 2010
Est. completion date August 2012

Study information

Verified date October 2011
Source Seoul National University Hospital
Contact Ki Ho Park, M.D., Ph.D.
Phone +82-2-2072-2438
Email kihopark@snu.ac.kr
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 22
Est. completion date August 2012
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Brimonidine/Timolol mixed combination
Twice per day, 1 drop at each time
Timolol
Twice per day, 1 drop at each time

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
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