Glaucoma, Open-Angle, Ocular Hypertension
Conditions
Brief summary
A study to evaluate the long-term safety of GANFORT® (bimatoprost 0.03% plus timolol 0.5%) in Chinese patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blocker or prostaglandin analogues.
Interventions
DRUGbimatoprost 0.03% plus timolol 0.5%
1 drop of bimatoprost 0.03% plus timolol 0.5% (GANFORT®) instilled in the affected eye once daily.
Sponsors
Allergan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of open-angle glaucoma or ocular hypertension that is insufficiently responsive to topical beta-blockers or prostaglandin analogues in one or both eyes * Is willing to stop other intraocular pressure (IOP)-lowering medications and switch to GANFORT® as a single agent in affected eye(s).
Exclusion criteria
* Reactive airway disease including bronchial asthma or a history of bronchial asthma or severe chronic obstructive pulmonary disease * Sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block, not controlled with pacemaker. Overt cardiac failure, cardiogenic shock.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events | 24 Weeks |
Countries
China
Outcome results
None listed