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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01446497
Recruitment Status : Unknown
Verified October 2011 by Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : October 5, 2011
Last Update Posted : October 5, 2011
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Normal Tension Glaucoma Drug: Brimonidine/Timolol mixed combination Drug: Timolol Phase 4

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2010
Primary Completion Date : August 2011
Estimated Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Timolol
non selective beta blocker, aqueous humor suppressant ophthalmic solution
Drug: Brimonidine/Timolol mixed combination
Twice per day, 1 drop at each time
Other Name: Combigan
Active Comparator: Combigan (Timolol/Brimonidine) combination drug
Brimonidine: alpha-2 agonist
Drug: Timolol
Twice per day, 1 drop at each time
Other Name: Timoptic XE

Outcome Measures

Primary Outcome Measures :
  1. Change from baseline in intraocular pressure at 12 weeks [ Time Frame: 12 weeks after the initial treatment ]
    Intraocular pressure (IOP) check by Goldmann applanation tonometry with topical anesthetic eyedrop

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01446497

Contact: Ki Ho Park, M.D., Ph.D. +82-2-2072-2438 ext 3172 kihopark@snu.ac.kr
Contact: Jae Hoon Jeong, M.D. +82-2-2072-2438 ext 3110 j2h23@hanmail.net

Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Ki Ho Park, M.D., Ph.D.    +82-2-2072-2438 ext 3172    kihopark@snu.ac.kr   
Contact: Jae Hoon Jeong, M.D.    +82-2-2072-2438 ext 3110    j2h23@hanmali.net   
Sponsors and Collaborators
Seoul National University Hospital
Principal Investigator: Ki Ho Park, M.D, Ph.D. Seoul National University Hospital
More Information

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01446497     History of Changes
Other Study ID Numbers: H-1008-059-327
KHP01 ( Registry Identifier: SNUH )
First Posted: October 5, 2011    Key Record Dates
Last Update Posted: October 5, 2011
Last Verified: October 2011

Keywords provided by Seoul National University Hospital:
Normal tension glaucoma
Antiglaucoma ophthalmic solution
Combination drugs

Additional relevant MeSH terms:
Low Tension Glaucoma
Ocular Hypertension
Eye Diseases
Optic Nerve Diseases
Ophthalmic Solutions
Brimonidine Tartrate, Timolol Maleate Drug Combination
Brimonidine Tartrate
Pharmaceutical Solutions
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists