Comparing Safety and Efficacy of Combigan® and Lumigan® With Lumigan® Alone in Glaucoma or Ocular Hypertension Subjects Treated With Xalatan®

Phase 4

Completed

• Conditions: Glaucoma; Ocular Hypertension
• Interventions: Drug: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution; bimatoprost 0.03% ophthalmic solution; Drug: bimatoprost 0.03% ophthalmic solution; hypromellose 0.2% eyedrops

• Registration Number: NCT01170884
• Lead Sponsor: Allergan

Brief Summary

Comparing Safety and Efficacy of Combigan® and Lumigan® with Lumigan® Alone in Glaucoma or Ocular Hypertension Subjects Treated with Xalatan®.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-07-26
• Study First Submitted QC: 2010-07-26
• Study First Posted: 2010-07-27
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Results First Submitted: 2011-12-07
• Results First Submitted QC: 2011-12-07
• Results First Posted: 2012-01-12
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-10
• Last Update Posted: 2019-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

• Diagnosed with glaucoma or ocular hypertension.
• Visual Acuity 20/100 or better in both eyes

Exclusion Criteria

• Any active ocular disease
• History of any intraocular surgery or glaucoma laser surgery within 3 months
• Contraindication to pupil dilation
• Use of topical, periorbital, intravitreal, or systemic steroid within 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combigan® + Lumigan®	fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution; bimatoprost 0.03% ophthalmic solution	COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution)
Lumigan®	bimatoprost 0.03% ophthalmic solution; hypromellose 0.2% eyedrops	LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes

Primary Outcome Measures

Name	Time	Method
Mean Diurnal Intraocular Pressure (IOP) at Week 12	Week 12	Mean Diurnal (average of 8 AM, 10 AM, and 4 PM time points) IOP at Week 12 in the study eye. IOP is a measurement of the fluid pressure inside the eye.