A Study of Bimatoprost 0.01% in the Clinical Setting

Completed

• Conditions: Ocular Hypertension; Glaucoma, Primary Open Angle
• Interventions: Drug: Bimatoprost 0.01%

• Registration Number: NCT01814761
• Lead Sponsor: Allergan

Brief Summary

This is a study of bimatoprost 0.01% (LUMIGAN® 0.01%) in subjects with primary open-angle glaucoma (POAG) or ocular hypertension (OH) who require further treatment for elevated intraocular pressure (IOP).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-18
• Study First Submitted QC: 2013-03-18
• Study First Posted: 2013-03-20
• Study Start: 2013-05
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2015-09
• Results First Submitted: 2015-09-28
• Results First Submitted QC: 2015-09-28
• Last Update Submitted: 2015-09-28
• Results First Posted: 2015-10-26
• Last Update Posted: 2015-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 312

Inclusion Criteria

• Diagnosis of primary open-angle glaucoma or ocular hypertension
• Determined by the treating physician to require treatment with bimatoprost 0.01%.

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Exclusion Criteria

• Previous use of Lumigan® 0.01%

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pts with POAG or OH (Previously Treatment Naive)	Bimatoprost 0.01%	Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
Pts with POAG or OH (Switched Monotherapy)	Bimatoprost 0.01%	Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).

Primary Outcome Measures

Name	Time	Method
Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale	12 Weeks	Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia is graded in the study eye on a 5-point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). The numbers of patients in each severity grade are presented.

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients Who Discontinue Due to an Adverse Event	12 Weeks	An adverse event is any untoward medical occurrence associated with the use of a drug, whether or not considered drug related.
Overall Percent Change From Baseline in IOP	Baseline, Week 12	IOP is a measure of the fluid pressure inside the eye. A negative number change response indicates a reduction in IOP (improvement) and a positive number change response indicates an increase in IOP (worsening).
Change From Baseline in Intraocular Pressure (IOP) in the Study Eye	Baseline, Week 12	IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening).