Safety and Efficacy of Different Formulations of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

Phase 3

Completed

• Conditions: Ocular Hypertension; Glaucoma
• Interventions: Drug: Bimatoprost 0.03% Ophthalmic Solution; Drug: Bimatoprost 0.03% Formulation B Ophthalmic Solution

• Registration Number: NCT01099774
• Lead Sponsor: Allergan

Brief Summary

This study will evaluate the safety and efficacy of bimatoprost 0.03% formulation B ophthalmic solution with LUMIGAN® (bimatoprost ophthalmic solution 0.03%) once daily for 12 weeks in patients with glaucoma or ocular hypertension

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-06
• Study First Submitted QC: 2010-04-06
• Study First Posted: 2010-04-08
• Study Start: 2010-05-01
• Primary Completion: 2011-04-29
• Study Completion: 2011-04-29
• Results First Submitted: 2012-04-03
• Results First Submitted QC: 2012-04-03
• Results First Posted: 2012-04-27
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-09
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 597

Inclusion Criteria

• Patient has ocular hypertension or glaucoma in both eyes
• Requires IOP-lowering therapy in each eye

Exclusion Criteria

• 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 0.03% Ophthalmic Solution	Bimatoprost 0.03% Ophthalmic Solution	Bimatoprost 0.03% Ophthalmic Solution
Bimatoprost 0.03% Formulation B Ophthalmic Solution	Bimatoprost 0.03% Formulation B Ophthalmic Solution	Bimatoprost 0.03% Formulation B Ophthalmic Solution

Primary Outcome Measures

Name	Time	Method
Average Eye IOP at Week 12	Baseline, Week 12	Average Eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported. Baseline data are included for reference only.
Average Eye IOP at Week 6	Week 6	Average Eye IOP at Week 6 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported.
Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12	Baseline, Week 12	Change from baseline in worse eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements in the worse eye were evaluated at hours 0, 2, and 8. A negative number change from baseline indicated a reduction in IOP, and a positive number change from baseline indicated an increase in IOP.
Average Eye IOP at Week 2	Week 2	Average Eye IOP at Week 2 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported.