Efficacy and Safety of COMBIGAN® in Korean Patients With Primary Open Angle Glaucoma (POAG) and Normal Tension Glaucoma (NTG)
Primary Purpose
Glaucoma, Open-Angle, Normal Tension Glaucoma
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
brimonidine tartrate/timolol malate Ophthalmic Solution
bimatoprost ophthalmic solution 0.01%
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma, Open-Angle
Eligibility Criteria
Inclusion Criteria:
- Patients with Primary open angle glaucoma (Regardless of Intraocular pressure)
- Previous history of topical beta-blocker use and insufficiently controlled IOP
Exclusion Criteria:
- Pigmentary or exfoliative glaucoma
- History of angle-closure or an occludable angle by gonioscopy
- Prior filtration or laser iridotomy
- Argon laser trabeculoplasty or Selective laser trabeculoplasty performed less than 6 months
- History or signs of chronic inflammatory eye disease, ocular trauma, or potentially progressive retinal disease
Sites / Locations
- Pusan National University Hospital, Pusan National University School of Medicine
- Yeungnam University Hospital, Yeungnam University College of Medicine
- Chungnam National University Hospital, Chungnam National University College of Medicine
- Chonnam National University Hospital, Chonnam National University Medical School
- Seoul National University Bundang Hospital, Seoul National University College of Medicine
- Seoul National University Hospital, Seoul National University College of Medicine
- Kangbuk Samsung Medical Center, Sungkyunkwan University School of Medicine
- Seoul St. Mary's Hospital, The Catholic University of Korea College of Medicine
- Kim's Eye Hospital, Konyang University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
COMBIGAN®
COMBIGAN® + LUMIGAN® 0.01%
Arm Description
One drop of COMBIGAN® in the affected eye, administered twice daily for 12 months
LUMIGAN® will be administered once daily in the evening 5 minutes after COMBIGAN® instillation in patients who require additional IOP lowering.
Outcomes
Primary Outcome Measures
Mean IOP change from Baseline (11AM point)
Secondary Outcome Measures
Mean IOP change from Baseline (11AM point)
Mean IOP change from baseline (11AM point) in the following patient sub-groups
patients with NTG
patients with POAG
patients taking Combigan alone
patients taking Combigan plus additional Lumigan 0.01%
Mean IOP change from Baseline (9AM point)
Mean IOP change from baseline (9AM point) in the following patient sub-groups
patients with NTG
patients with POAG
patients taking Combigan alone
patients taking Combigan plus additional Lumigan 0.01%
Mean change in Mean deviation (MD) from Baseline
Mean change in Pattern standard deviation (PSD) from Baseline
Mean change in Visual field index (VFI) from Baseline
Mean change in cup to disc ratio (C/D ratio) from Baseline
Rate of VF progression measured as change in VF index over time
Rate of VF progression during 12 months in the following patient sub-groups.
patients with NTG
patients with POAG
patients taking Combigan alone
patients taking Combigan plus additional Lumigan 0.01%
Mean duration of achieving the target IOP with COMBIGAN® alone
The percentage of subjects of achieving the target IOP with COMBIGAN® alone during 12 months
Definition of patient demographics (descriptive analysis of age and gender)
Define patient demographics in the following patient sub-groups:
patients with NTG
patients with POAG
patients taking Combigan alone
patients taking Combigan plus additional Lumigan 0.01%
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02863705
Brief Title
Efficacy and Safety of COMBIGAN® in Korean Patients With Primary Open Angle Glaucoma (POAG) and Normal Tension Glaucoma (NTG)
Official Title
A 12-Month, Phase 4, Open Label, Multicenter, Trial to Assess the Efficacy and Safety of COMBIGAN® in Korean Patients With Primary Open Angle Glaucoma (POAG) and Normal Tension Glaucoma (NTG)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
July 5, 2016 (Actual)
Primary Completion Date
July 25, 2018 (Actual)
Study Completion Date
July 25, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to evaluate the long-term efficacy and safety of COMBIGAN® (brimonidine tartrate/timolol malate) in patients only using COMBIGAN® (brimonidine tartrate/timolol malate) and also in patients who require additional IOP lowering with LUMIGAN® (bimatoprost) 0.01%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle, Normal Tension Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COMBIGAN®
Arm Type
Experimental
Arm Description
One drop of COMBIGAN® in the affected eye, administered twice daily for 12 months
Arm Title
COMBIGAN® + LUMIGAN® 0.01%
Arm Type
Experimental
Arm Description
LUMIGAN® will be administered once daily in the evening 5 minutes after COMBIGAN® instillation in patients who require additional IOP lowering.
Intervention Type
Drug
Intervention Name(s)
brimonidine tartrate/timolol malate Ophthalmic Solution
Intervention Description
One drop of brimonidine tartrate/timolol malate (COMBIGAN®) Ophthalmic Solution in the affected eye, administered twice daily for 12 months
Intervention Type
Drug
Intervention Name(s)
bimatoprost ophthalmic solution 0.01%
Intervention Description
Bimatoprost ophthalmic solution 0.01% (LUMIGAN®) administered once daily in the evening 5 minutes after COMBIGAN® instillation if additional lowering IOP is needed
Primary Outcome Measure Information:
Title
Mean IOP change from Baseline (11AM point)
Time Frame
Baseline, Month 12
Secondary Outcome Measure Information:
Title
Mean IOP change from Baseline (11AM point)
Description
Mean IOP change from baseline (11AM point) in the following patient sub-groups
patients with NTG
patients with POAG
patients taking Combigan alone
patients taking Combigan plus additional Lumigan 0.01%
Time Frame
Baseline, Month 12
Title
Mean IOP change from Baseline (9AM point)
Description
Mean IOP change from baseline (9AM point) in the following patient sub-groups
patients with NTG
patients with POAG
patients taking Combigan alone
patients taking Combigan plus additional Lumigan 0.01%
Time Frame
Baseline, Month 12
Title
Mean change in Mean deviation (MD) from Baseline
Time Frame
Baseline, Month 12
Title
Mean change in Pattern standard deviation (PSD) from Baseline
Time Frame
Baseline, Month 12
Title
Mean change in Visual field index (VFI) from Baseline
Time Frame
Baseline, Month 12
Title
Mean change in cup to disc ratio (C/D ratio) from Baseline
Time Frame
Baseline, Month 12
Title
Rate of VF progression measured as change in VF index over time
Description
Rate of VF progression during 12 months in the following patient sub-groups.
patients with NTG
patients with POAG
patients taking Combigan alone
patients taking Combigan plus additional Lumigan 0.01%
Time Frame
Baseline, Month 12
Title
Mean duration of achieving the target IOP with COMBIGAN® alone
Time Frame
12 Months
Title
The percentage of subjects of achieving the target IOP with COMBIGAN® alone during 12 months
Time Frame
12 Months
Title
Definition of patient demographics (descriptive analysis of age and gender)
Description
Define patient demographics in the following patient sub-groups:
patients with NTG
patients with POAG
patients taking Combigan alone
patients taking Combigan plus additional Lumigan 0.01%
Time Frame
Baseline, Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with Primary open angle glaucoma (Regardless of Intraocular pressure)
Previous history of topical beta-blocker use and insufficiently controlled IOP
Exclusion Criteria:
Pigmentary or exfoliative glaucoma
History of angle-closure or an occludable angle by gonioscopy
Prior filtration or laser iridotomy
Argon laser trabeculoplasty or Selective laser trabeculoplasty performed less than 6 months
History or signs of chronic inflammatory eye disease, ocular trauma, or potentially progressive retinal disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joy Maglambayan
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Pusan National University Hospital, Pusan National University School of Medicine
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Yeungnam University Hospital, Yeungnam University College of Medicine
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital, Chungnam National University College of Medicine
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital, Chonnam National University Medical School
City
Gwangju
ZIP/Postal Code
61469
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital, Seoul National University College of Medicine
City
Gyeonggi-do
ZIP/Postal Code
13619
Country
Korea, Republic of
Facility Name
Seoul National University Hospital, Seoul National University College of Medicine
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Medical Center, Sungkyunkwan University School of Medicine
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
Facility Name
Seoul St. Mary's Hospital, The Catholic University of Korea College of Medicine
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Kim's Eye Hospital, Konyang University College of Medicine
City
Seoul
ZIP/Postal Code
07301
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of COMBIGAN® in Korean Patients With Primary Open Angle Glaucoma (POAG) and Normal Tension Glaucoma (NTG)
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