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

Primary Purpose

Normal Tension Glaucoma

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Brimonidine/Timolol mixed combination
Timolol
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Normal Tension Glaucoma focused on measuring Normal tension glaucoma, Antiglaucoma ophthalmic solution, Brimonidine, Timolol, Combination drugs

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Timolol

Combigan (Timolol/Brimonidine) combination drug

Arm Description

non selective beta blocker, aqueous humor suppressant ophthalmic solution

Brimonidine: alpha-2 agonist

Outcomes

Primary Outcome Measures

Change from baseline in intraocular pressure at 12 weeks
Intraocular pressure (IOP) check by Goldmann applanation tonometry with topical anesthetic eyedrop

Secondary Outcome Measures

Full Information

First Posted
September 25, 2011
Last Updated
October 3, 2011
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01446497
Brief Title
Efficacy and Safety Study of Combigan and 0.5% Timoptic in Normal Tension Glaucoma
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 Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Normal Tension Glaucoma
Keywords
Normal tension glaucoma, Antiglaucoma ophthalmic solution, Brimonidine, Timolol, Combination drugs

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Timolol
Arm Type
Active Comparator
Arm Description
non selective beta blocker, aqueous humor suppressant ophthalmic solution
Arm Title
Combigan (Timolol/Brimonidine) combination drug
Arm Type
Active Comparator
Arm Description
Brimonidine: alpha-2 agonist
Intervention Type
Drug
Intervention Name(s)
Brimonidine/Timolol mixed combination
Other Intervention Name(s)
Combigan
Intervention Description
Twice per day, 1 drop at each time
Intervention Type
Drug
Intervention Name(s)
Timolol
Other Intervention Name(s)
Timoptic XE
Intervention Description
Twice per day, 1 drop at each time
Primary Outcome Measure Information:
Title
Change from baseline in intraocular pressure at 12 weeks
Description
Intraocular pressure (IOP) check by Goldmann applanation tonometry with topical anesthetic eyedrop
Time Frame
12 weeks after the initial treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ki Ho Park, M.D., Ph.D.
Phone
+82-2-2072-2438
Ext
3172
Email
kihopark@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Jae Hoon Jeong, M.D.
Phone
+82-2-2072-2438
Ext
3110
Email
j2h23@hanmail.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ki Ho Park, M.D, Ph.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ki Ho Park, M.D., Ph.D.
Phone
+82-2-2072-2438
Ext
3172
Email
kihopark@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Jae Hoon Jeong, M.D.
Phone
+82-2-2072-2438
Ext
3110
Email
j2h23@hanmali.net

12. IPD Sharing Statement

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

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