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

Normal Tension Glaucoma Clinical Trial

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

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

• Glaucoma
• Low Tension Glaucoma
• Normal Tension Glaucoma

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