Safety and Efficacy of AGN-210669 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension

Allergan

Status and phase: Completed; Phase 2

Conditions: Ocular Hypertension; Glaucoma, Open-Angle

Treatments: Drug: AGN-210669; Drug: bimatoprost vehicle; Drug: bimatoprost

Study type: Interventional

Funder types: Industry

Identifiers

NCT01291108

210669-013

Details and patient eligibility

About

This study will evaluate the safety and efficacy of AGN-210669 ophthalmic solution compared with bimatoprost ophthalmic solution (Lumigan®) as monotherapy and adjunctive therapy in patients with primary open-angle glaucoma or ocular hypertension.

Enrollment: 125 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of primary open-angle glaucoma or ocular hypertension in each eye
• Requires bilateral treatment with an IOP-lowering medication
• Best corrected visual acuity of 20/100 or better in each eye

Exclusion criteria

• Use of oral, intramuscular, intravenous or topical ophthalmic corticosteroids within 2 months
• Inability to fast for up to 10 hours
• Prior refractive laser surgery (eg, LASIK, radial keratectomy, photorefractive keratectomy)
• Intraocular surgery or IOP-lowering laser surgery (eg, laser trabeculoplasty) within 6 months
• Current or anticipated use of artificial tears or any ocular medications aside from study medications during study
• Anticipated wearing of contact lenses during study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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125 participants in 6 patient groups

AGN-210669

Experimental group

Description:

AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1.

Treatment:

Drug: AGN-210669

AGN-210669 + bimatoprost

Experimental group

Description:

AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% applied as 1 drop of each treatment in both eyes every evening during Month 2.

Treatment:

Drug: bimatoprost

Drug: AGN-210669

AGN-210669 + bimatoprost vehicle

Experimental group

Description:

AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.

Treatment:

Drug: bimatoprost vehicle

Drug: AGN-210669

bimatoprost

Active Comparator group

Description:

bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1.

Treatment:

Drug: bimatoprost

bimatoprost + AGN-210669

Experimental group

Description:

bimatoprost ophthalmic solution 0.03% + AGN-210669 0.05% applied as 1 drop of each treatment in both eyes every evening during Month 2.

Treatment:

Drug: bimatoprost

Drug: AGN-210669

bimatoprost + bimatoprost vehicle

Other group

Description:

bimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.

Treatment:

Drug: bimatoprost vehicle

Drug: bimatoprost