This is a multicenter, open-label, dose escalation (Cohort 1) to masked, randomized, parallel-groups (Cohort 2) and (Cohort 3) study to evaluate the safety and efficacy of AGN-193408 SR in participants with open-angle glaucoma or ocular hypertension
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
96
An implant containing preservative-free AGN-193408 dispersed in a biodegradable polymer matrix. Implants are preloaded into an applicator to facilitate insertion of the implant into the anterior chamber of the study eye.
Control Treatment in Fellow Eye Lumigan 0.01% is a topical eye drop that is a solution containing 0.1 mg/mL bimatoprost
Needleless applicator contacting similar intracameral insertion location on eye as AGN-193408 SR.
Change from Baseline in Hour 0 Intraocular Pressure (IOP) in the Study Eye
IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Time frame: Baseline to Month 36
Number of participants experiencing treatment emergent adverse events
Time frame: Baseline to Month 36
Time to Rescue Treatment or Re-Treatment in the Study Eye
Time to rescue treatment or the second treatment is defined as the time between the first treatment and the second treatment in the study eye.
Time frame: Baseline to Month 36
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Vehicle eye drops (for masking) will be administered once daily in the evening starting on Day 1 in the study eye during Cohort 2.
An implant containing preservative-free AGN-193408 dispersed in a biodegradable polymer matrix. Implants are preloaded into an applicator to facilitate insertion of the implant in the study eye.
Needleless applicator contacting similar insertion location on eye as AGN-193408 SR.
Vehicle eye drops (for masking) will be administered once daily in the evening starting on Day 1 in the study eye during Cohort 3.
Horizon Eye Specialists & Lasik Center - Sun City /ID# 252153
Sun City, Arizona, United States
RECRUITINGGlobal Research Management /ID# 241699
Glendale, California, United States
RECRUITINGUnited Medical Research Institute /ID# 241701
Inglewood, California, United States
COMPLETEDLakeside Vision Center /ID# 241698
Irvine, California, United States
RECRUITINGThe Eye Research Foundation /ID# 234528
Newport Beach, California, United States
RECRUITINGSacramento Eye Consultants /ID# 241697
Sacramento, California, United States
RECRUITINGPremiere Practice Management LLC /ID# 235957
Torrance, California, United States
COMPLETEDWolstan & Goldberg Eye Associates /ID# 241700
Torrance, California, United States
RECRUITINGConnecticut Eye Consultants P.C. /ID# 235862
Danbury, Connecticut, United States
RECRUITINGBrandon Eye Associates - Brandon /ID# 276600
Brandon, Florida, United States
RECRUITING...and 39 more locations