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

October 3, 2011 updated by: Seoul National University Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

22

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Recruiting
        • Seoul National University Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Combigan
Active Comparator: Combigan (Timolol/Brimonidine) combination drug
Brimonidine: alpha-2 agonist
Drug: Timolol
Twice per day, 1 drop at each time
Other Names:
  • Timoptic XE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks after the initial treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Ki Ho Park, M.D, Ph.D., Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Anticipated)

August 1, 2012

Study Registration Dates

First Submitted

September 25, 2011

First Submitted That Met QC Criteria

October 3, 2011

First Posted (Estimate)

October 5, 2011

Study Record Updates

Last Update Posted (Estimate)

October 5, 2011

Last Update Submitted That Met QC Criteria

October 3, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1008-059-327
  • KHP01 (Registry Identifier: SNUH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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