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