Efficacy and Safety of COMBIGAN® in Korean Patients With Primary Open Angle Glaucoma (POAG) and Normal Tension Glaucoma (NTG)
- Conditions
- Glaucoma, Open-AngleNormal Tension Glaucoma
- Interventions
- Registration Number
- NCT02863705
- Lead Sponsor
- Allergan
- 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%.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 118
- Patients with Primary open angle glaucoma (Regardless of Intraocular pressure)
- Previous history of topical beta-blocker use and insufficiently controlled IOP
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description COMBIGAN® + LUMIGAN® 0.01% brimonidine tartrate/timolol malate Ophthalmic Solution LUMIGAN® will be administered once daily in the evening 5 minutes after COMBIGAN® instillation in patients who require additional IOP lowering. COMBIGAN® + LUMIGAN® 0.01% bimatoprost ophthalmic solution 0.01% LUMIGAN® will be administered once daily in the evening 5 minutes after COMBIGAN® instillation in patients who require additional IOP lowering. COMBIGAN® brimonidine tartrate/timolol malate Ophthalmic Solution One drop of COMBIGAN® in the affected eye, administered twice daily for 12 months
- Primary Outcome Measures
Name Time Method Mean IOP change from Baseline (11AM point) Baseline, Month 12
- Secondary Outcome Measures
Name Time Method Mean change in Mean deviation (MD) from Baseline Baseline, Month 12 Mean change in Pattern standard deviation (PSD) from Baseline Baseline, Month 12 Mean change in Visual field index (VFI) from Baseline Baseline, Month 12 The percentage of subjects of achieving the target IOP with COMBIGAN® alone during 12 months 12 Months Mean IOP change from Baseline (11AM point) Baseline, Month 12 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%Mean IOP change from Baseline (9AM point) Baseline, Month 12 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%Mean change in cup to disc ratio (C/D ratio) from Baseline Baseline, Month 12 Rate of VF progression measured as change in VF index over time Baseline, Month 12 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%Mean duration of achieving the target IOP with COMBIGAN® alone 12 Months Definition of patient demographics (descriptive analysis of age and gender) Baseline, Month 12 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%
Trial Locations
- Locations (9)
Pusan National University Hospital, Pusan National University School of Medicine
🇰🇷Busan, Korea, Republic of
Seoul St. Mary's Hospital, The Catholic University of Korea College of Medicine
🇰🇷Seoul, Korea, Republic of
Chungnam National University Hospital, Chungnam National University College of Medicine
🇰🇷Daejeon, Korea, Republic of
Chonnam National University Hospital, Chonnam National University Medical School
🇰🇷Gwangju, Korea, Republic of
Kangbuk Samsung Medical Center, Sungkyunkwan University School of Medicine
🇰🇷Seoul, Korea, Republic of
Seoul National University Bundang Hospital, Seoul National University College of Medicine
🇰🇷Gyeonggi-do, Korea, Republic of
Seoul National University Hospital, Seoul National University College of Medicine
🇰🇷Seoul, Korea, Republic of
Kim's Eye Hospital, Konyang University College of Medicine
🇰🇷Seoul, Korea, Republic of
Yeungnam University Hospital, Yeungnam University College of Medicine
🇰🇷Daegu, Korea, Republic of