Efficacy and Safety Study of Combigan and 0.5% Timoptic in Normal Tension Glaucoma
NCT ID: NCT01446497
Last Updated: 2011-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
22 participants
INTERVENTIONAL
2010-10-31
2012-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Timolol
non selective beta blocker, aqueous humor suppressant ophthalmic solution
Brimonidine/Timolol mixed combination
Twice per day, 1 drop at each time
Combigan (Timolol/Brimonidine) combination drug
Brimonidine: alpha-2 agonist
Timolol
Twice per day, 1 drop at each time
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Brimonidine/Timolol mixed combination
Twice per day, 1 drop at each time
Timolol
Twice per day, 1 drop at each time
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* baseline IOP under 22 mmHg,both anterior chamber angle \> Grade 3\~4 by Shaffer grading system
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Seoul National University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ki Ho Park, M.D, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Seoul National University Hospital
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KHP01
Identifier Type: REGISTRY
Identifier Source: secondary_id
H-1008-059-327
Identifier Type: -
Identifier Source: org_study_id