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

NCT01863953 Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	Allergan
Phase	Phase 2
Status	COMPLETED
Enrolment	112
Start date	2013-06
Completion	2013-12

Conditions

• Glaucoma
• Ocular Hypertension

Interventions

• Fixed-Combination Bimatoprost/Brimonidine
• Bimatoprost Ophthalmic Solution 0.01%
• Vehicle Ophthalmic Solution
• Brimonidine Tartrate Ophthalmic Solution 0.2%

Primary outcomes

• 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).

Countries

United States