A Safety Study of Bimatoprost in Patients With Glaucoma or Ocular Hypertension

Phase 3

Completed

• Conditions: Glaucoma; Ocular Hypertension
• Interventions: Drug: Bimatoprost 0.03%; Drug: Bimatoprost 0.01%

• Registration Number: NCT01830140
• Lead Sponsor: Allergan

Brief Summary

This safety study will evaluate bimatoprost 0.01% and 0.03% in patients with glaucoma or ocular hypertension (OHT).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-10
• Study First Submitted QC: 2013-04-10
• Study First Posted: 2013-04-12
• Study Start: 2013-07
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2015-04
• Results First Submitted: 2015-04-21
• Results First Submitted QC: 2015-04-21
• Last Update Submitted: 2015-04-21
• Results First Posted: 2015-05-06
• Last Update Posted: 2015-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 466

Inclusion Criteria

• Diagnosis of glaucoma or ocular hypertension

Read More

Exclusion Criteria

• Active ocular disease other than glaucoma or ocular hypertension
• Require chronic use of ocular medications other than the study medication during the study (intermittent use of artificial tear solution will be permitted)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bimatoprost 0.03%	Bimatoprost 0.03%	Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
Bimatoprost 0.01%	Bimatoprost 0.01%	Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye	Baseline, 6 Weeks	Macroscopic conjunctival hyperemia (eye redness) is graded in each eye on a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe). An increase (worsening) in macroscopic conjunctival hyperemia is defined as an increase in macroscopic conjunctival hyperemia grade of at least 1 from baseline in either eye.