Safety and Efficacy of Bimatoprost Compared With Latanoprost in Patients With Glaucoma or Ocular Hypertension

Phase 4

Completed

• Conditions: Ocular Hypertension; Glaucoma
• Interventions: Drug: bimatoprost 0.03% eye drops; Drug: latanoprost 0.005% eye drops

• Registration Number: NCT00541242
• Lead Sponsor: Allergan

Brief Summary

The study will compare the safety and efficacy of Bimatoprost and Latanoprost in patients with glaucoma or ocular hypertension

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-10-05
• Study First Submitted QC: 2007-10-05
• Study First Posted: 2007-10-10
• Study Start: 2007-12
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2011-09
• Results First Submitted: 2011-09-19
• Results First Submitted QC: 2011-09-19
• Last Update Submitted: 2011-09-19
• Results First Posted: 2011-10-27
• Last Update Posted: 2011-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 586

Inclusion Criteria

• Ocular hypertension or chronic glaucoma
• Patient requires IOP-lowering therapy in both eyes

Exclusion Criteria

• Uncontrolled medical conditions
• Hypersensitivity to study medications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	bimatoprost 0.03% eye drops	bimatoprost 0.03% eye drops
2	latanoprost 0.005% eye drops	latanoprost 0.005% eye drops

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 12	Baseline, Week 12	Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP.
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 18	Baseline, Week 18	Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP.