A Safety and Efficacy Study of Fixed-Combination Bimatoprost and Brimonidine in Chronic Glaucoma or Ocular Hypertension

Phase 2

Completed

• Conditions: Glaucoma; Ocular Hypertension
• Interventions: Drug: Brimonidine Tartrate Ophthalmic Solution 0.2%; Drug: Bimatoprost Ophthalmic Solution 0.01%; Drug: Fixed-Combination Bimatoprost/Brimonidine; Drug: Vehicle Ophthalmic Solution

• Registration Number: NCT01863953
• Lead Sponsor: Allergan

Brief Summary

This is a safety and efficacy study of fixed-combination bimatoprost and brimonidine compared with LUMIGAN® and ALPHAGAN® in patients with chronic glaucoma or ocular hypertension.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-24
• Study First Submitted QC: 2013-05-24
• Study First Posted: 2013-05-29
• Study Start: 2013-06
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-01
• Results First Submitted: 2015-01-16
• Results First Submitted QC: 2015-01-16
• Last Update Submitted: 2015-01-16
• Results First Posted: 2015-01-26
• Last Update Posted: 2015-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

• Diagnosis of ocular hypertension or glaucoma
• Requires intraocular pressure (IOP)-lowering therapy

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Exclusion Criteria

• Cataract surgery in one eye
• Ocular laser or intraocular surgery within 6 months
• Refractive surgery in either eye
• Anticipated use of contact lenses during the study
• Expected use of artificial tears during the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brimonidine Tartrate Ophthalmic Solution 0.2%	Brimonidine Tartrate Ophthalmic Solution 0.2%	One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
Bimatoprost Ophthalmic Solution 0.01% and Vehicle	Bimatoprost Ophthalmic Solution 0.01%	One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
Fixed-Combination Bimatoprost/Brimonidine	Fixed-Combination Bimatoprost/Brimonidine	One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
Bimatoprost Ophthalmic Solution 0.01% and Vehicle	Vehicle Ophthalmic Solution	One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Average Eye Mean Diurnal Intraocular Pressure (IOP)	Baseline, Day 42	IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. 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).

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Average Eye Mean Diurnal IOP	Baseline, Day 14, Day 28	IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. 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).
Average Eye Mean Diurnal IOP	Day 14, Day 28, Day 42	IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12.