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

Glaucoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01863953
• Other study ID #: 192024-082
• Status: Completed
• Phase: Phase 2
• First received: May 24, 2013
• Last updated: January 16, 2015
• Start date: June 2013
• Est. completion date: December 2013

Study information

• Verified date: January 2015
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of ocular hypertension or glaucoma

• Requires intraocular pressure (IOP)-lowering therapy

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Hypertension
• Ocular Hypertension

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Average Eye Mean Diurnal Intraocular Pressure (IOP)	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).	Baseline, Day 42	No
Secondary	Change From Baseline in Average Eye Mean Diurnal IOP	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).	Baseline, Day 14, Day 28	No
Secondary	Average Eye Mean Diurnal IOP	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.	Day 14, Day 28, Day 42	No