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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Seoul National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01446497
First received: September 25, 2011
Last updated: October 3, 2011
Last verified: October 2011
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

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


Estimated Enrollment: 22
Study Start Date: October 2010
Estimated Study Completion Date: August 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01446497

Contacts
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

Locations
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
Investigators
Principal Investigator: Ki Ho Park, M.D, Ph.D. Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01446497     History of Changes
Other Study ID Numbers: H-1008-059-327, KHP01
Study First Received: September 25, 2011
Last Updated: October 3, 2011
Health Authority: Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Glaucoma
Low Tension Glaucoma
Ocular Hypertension
Eye Diseases
Optic Nerve Diseases
Timolol
Brimonidine
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists

ClinicalTrials.gov processed this record on April 22, 2014