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

Allergan

Status and phase: Completed; Phase 2

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: Fixed-Combination Bimatoprost/Brimonidine; Drug: Vehicle Ophthalmic Solution; Drug: Brimonidine Tartrate Ophthalmic Solution 0.2%; Drug: Bimatoprost Ophthalmic Solution 0.01%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01863953

192024-082

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

112 participants in 3 patient groups

Fixed-Combination Bimatoprost/Brimonidine

Experimental group

Description:

One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.

Treatment:

Drug: Fixed-Combination Bimatoprost/Brimonidine

Bimatoprost Ophthalmic Solution 0.01% and Vehicle

Active Comparator group

Description:

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.

Treatment:

Drug: Vehicle Ophthalmic Solution

Drug: Bimatoprost Ophthalmic Solution 0.01%

Brimonidine Tartrate Ophthalmic Solution 0.2%

Active Comparator group

Description:

One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.

Treatment:

Drug: Brimonidine Tartrate Ophthalmic Solution 0.2%