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%.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
118
One drop of brimonidine tartrate/timolol malate (COMBIGAN®) Ophthalmic Solution in the affected eye, administered twice daily for 12 months
Bimatoprost ophthalmic solution 0.01% (LUMIGAN®) administered once daily in the evening 5 minutes after COMBIGAN® instillation if additional lowering IOP is needed
Pusan National University Hospital, Pusan National University School of Medicine
Busan, South Korea
Yeungnam University Hospital, Yeungnam University College of Medicine
Daegu, South Korea
Chungnam National University Hospital, Chungnam National University College of Medicine
Daejeon, South Korea
Mean IOP change from Baseline (11AM point)
Time frame: Baseline, Month 12
Mean IOP change from Baseline (11AM point)
Mean IOP change from baseline (11AM point) in the following patient sub-groups 1. patients with NTG 2. patients with POAG 3. patients taking Combigan alone 4. patients taking Combigan plus additional Lumigan 0.01%
Time frame: Baseline, Month 12
Mean IOP change from Baseline (9AM point)
Mean IOP change from baseline (9AM point) in the following patient sub-groups 1. patients with NTG 2. patients with POAG 3. patients taking Combigan alone 4. patients taking Combigan plus additional Lumigan 0.01%
Time frame: Baseline, Month 12
Mean change in Mean deviation (MD) from Baseline
Time frame: Baseline, Month 12
Mean change in Pattern standard deviation (PSD) from Baseline
Time frame: Baseline, Month 12
Mean change in Visual field index (VFI) from Baseline
Time frame: Baseline, Month 12
Mean change in cup to disc ratio (C/D ratio) from Baseline
Time frame: Baseline, Month 12
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. 1. patients with NTG 2. patients with POAG 3. patients taking Combigan alone 4. patients taking Combigan plus additional Lumigan 0.01%
Time frame: Baseline, Month 12
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Chonnam National University Hospital, Chonnam National University Medical School
Gwangju, South Korea
Seoul National University Bundang Hospital, Seoul National University College of Medicine
Gyeonggi-do, South Korea
Seoul National University Hospital, Seoul National University College of Medicine
Seoul, South Korea
Kangbuk Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, South Korea
Seoul St. Mary's Hospital, The Catholic University of Korea College of Medicine
Seoul, South Korea
Kim's Eye Hospital, Konyang University College of Medicine
Seoul, South Korea
Mean duration of achieving the target IOP with COMBIGAN® alone
Time frame: 12 Months
The percentage of subjects of achieving the target IOP with COMBIGAN® alone during 12 months
Time frame: 12 Months
Definition of patient demographics (descriptive analysis of age and gender)
Define patient demographics in the following patient sub-groups: 1. patients with NTG 2. patients with POAG 3. patients taking Combigan alone 4. patients taking Combigan plus additional Lumigan 0.01%
Time frame: Baseline, Month 12