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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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 Norm

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

Detailed Summary:

  • 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

Sponsor: Seoul National University Hospital

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Seoul National University Hospital

Dates:
Date Received: September 25, 2011
Date Started: October 2010
Date Completion: August 2012
Last Updated: October 3, 2011
Last Verified: October 2011