Efficacy and Safety of COMBIGAN® in Korean Patients With Primary Open Angle Glaucoma (POAG) and Normal Tension Glaucoma (NTG)

Study Overview
=================
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%.

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)

Conditions
-----------------
Glaucoma, Open-Angle, Normal Tension Glaucoma

Intervention / Treatment
-----------------
* Drug: brimonidine tartrate/timolol malate Ophthalmic Solution
* Drug: bimatoprost ophthalmic solution 0.01%


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COMBIGAN®<br>One drop of COMBIGAN® in the affected eye, administered twice daily for 12 months | Drug: brimonidine tartrate/timolol malate Ophthalmic Solution<br>* One drop of brimonidine tartrate/timolol malate (COMBIGAN®) Ophthalmic Solution in the affected eye, administered twice daily for 12 months<br>|
| Experimental: COMBIGAN® + LUMIGAN® 0.01%<br>LUMIGAN® will be administered once daily in the evening 5 minutes after COMBIGAN® instillation in patients who require additional IOP lowering. | Drug: brimonidine tartrate/timolol malate Ophthalmic Solution<br>* One drop of brimonidine tartrate/timolol malate (COMBIGAN®) Ophthalmic Solution in the affected eye, administered twice daily for 12 months<br>Drug: bimatoprost ophthalmic solution 0.01%<br>* Bimatoprost ophthalmic solution 0.01% (LUMIGAN®) administered once daily in the evening 5 minutes after COMBIGAN® instillation if additional lowering IOP is needed<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean IOP change from Baseline (11AM point) |  | Baseline, Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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% | Baseline, Month 12 | 
| 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% | Baseline, Month 12 | 
| 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 | 
| 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 | 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% | Baseline, Month 12 | 
| Mean duration of achieving the target IOP with COMBIGAN® alone |  | 12 Months | 
| The percentage of subjects of achieving the target IOP with COMBIGAN® alone during 12 months |  | 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% | Baseline, Month 12 |