Safety and Efficacy of AGN-210669 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension
Overview
- Phase
- Phase 2
- Intervention
- AGN-210669
- Conditions
- Glaucoma, Open-Angle
- Sponsor
- Allergan
- Enrollment
- 125
- Primary Endpoint
- Change From Baseline in Average Eye IOP
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
AGN-210669
AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1.
Intervention: AGN-210669
AGN-210669 + bimatoprost
AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% applied as 1 drop of each treatment in both eyes every evening during Month 2.
Intervention: AGN-210669
AGN-210669 + bimatoprost
AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% applied as 1 drop of each treatment in both eyes every evening during Month 2.
Intervention: bimatoprost
AGN-210669 + bimatoprost vehicle
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.
Intervention: AGN-210669
AGN-210669 + bimatoprost vehicle
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.
Intervention: bimatoprost vehicle
bimatoprost
bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1.
Intervention: bimatoprost
bimatoprost + AGN-210669
bimatoprost ophthalmic solution 0.03% + AGN-210669 0.05% applied as 1 drop of each treatment in both eyes every evening during Month 2.
Intervention: AGN-210669
bimatoprost + AGN-210669
bimatoprost ophthalmic solution 0.03% + AGN-210669 0.05% applied as 1 drop of each treatment in both eyes every evening during Month 2.
Intervention: bimatoprost
bimatoprost + bimatoprost vehicle
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.
Intervention: bimatoprost
bimatoprost + bimatoprost vehicle
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.
Intervention: bimatoprost vehicle
Outcomes
Primary Outcomes
Change From Baseline in Average Eye IOP
Time Frame: Baseline, Day 57
IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes are used for the analyses. 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). Data are recorded at Hours 0, 4, 8, and 12.
Secondary Outcomes
- Change From Baseline in Worse Eye IOP(Baseline, Day 57)