Efficacy and Safety Study of Combigan and 0.5% Timoptic in Normal Tension Glaucoma
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
2 other identifiers
interventional
22
1 country
1
Brief Summary
Purpose To evaluate efficacy and safety of combigan(Brimonidine/Timolol) and 0.5% Timoptic (Timolol) ophthalmic solutions in normal tension glaucoma patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Oct 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 25, 2011
CompletedFirst Posted
Study publicly available on registry
October 5, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedOctober 5, 2011
October 1, 2011
10 months
September 25, 2011
October 3, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Timolol
ACTIVE COMPARATORnon selective beta blocker, aqueous humor suppressant ophthalmic solution
Combigan (Timolol/Brimonidine) combination drug
ACTIVE COMPARATORBrimonidine: alpha-2 agonist
Interventions
Twice per day, 1 drop at each time
Twice per day, 1 drop at each time
Eligibility Criteria
You may qualify if:
- over 18 years old
- baseline IOP under 22 mmHg,both anterior chamber angle \> Grade 3\~4 by Shaffer grading system
You may not qualify if:
- 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
- \~3 degree A-V block,
- MAO inhibitor use
- anti depressant use
- untreated pheochromocytoma
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 110-744, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ki Ho Park, M.D, Ph.D.
Seoul National University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2011
First Posted
October 5, 2011
Study Start
October 1, 2010
Primary Completion
August 1, 2011
Study Completion
August 1, 2012
Last Updated
October 5, 2011
Record last verified: 2011-10