Glaucoma, Open-Angle, Normal Tension Glaucoma
Conditions
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%.
Interventions
DRUGbrimonidine tartrate/timolol malate Ophthalmic Solution
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
Sponsors
Allergan
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean IOP change from Baseline (11AM point) | Baseline, Month 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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% |
| 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 | — |
| 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) | 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% |
| Mean change in cup to disc ratio (C/D ratio) from Baseline | Baseline, Month 12 | — |
Countries
South Korea
Outcome results
None listed