Safety and Efficacy of a New Formulation of Bimatoprost/Timolol Ophthalmic Solution Compared With Bimatoprost/Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
- Conditions
- GlaucomaOcular Hypertension
- Interventions
- Drug: bimatoprost/timolol fixed combination ophthalmic solution
- Registration Number
- NCT01177098
- Lead Sponsor
- Allergan
- Brief Summary
This study will evaluate the safety and efficacy of bimatoprost/timolol formulation A ophthalmic solution with Ganfort® (bimatoprost 0.03%/timolol 0.5% ophthalmic solution) once daily for 12 weeks in patients with glaucoma or ocular hypertension.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 561
- Patient has ocular hypertension or glaucoma in both eyes
- Requires IOP-lowering therapy in each eye
- Active or recurrent eye disease that would interfere with interpretation of study data in either eye
- History of any eye surgery or laser in either eye within 6 months
- Required chronic use of other eye medications during the study
- Anticipated wearing of contact lenses during the study.
- Intermittent use of oral, intramuscular, or intravenous corticosteroids within 21 days
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description bimatoprost/timolol formulation A bimatoprost /timolol formulation A fixed combination ophthalmic solution One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks. bimatoprost/timolol fixed combination ophthalmic solution bimatoprost/timolol fixed combination ophthalmic solution One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
- Primary Outcome Measures
Name Time Method Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2 Week 2 Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 2 at Hour 0, Hour 2 and Hour 8.
Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 Baseline, Week 12 Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement).
Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6 Week 6 Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 6 at Hour 0, Hour 2 and Hour 8.
Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 Week 12 Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 12 at Hour 0, Hour 2 and Hour 8.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12 Baseline, Week 12 Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8. Average eye IOP is defined as the average of the IOP in both eyes. A negative number change from baseline indicates a reduction in IOP (improvement).
Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12 Baseline, Week 12 Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement).