AGN-193408 SR in the Treatment of Open-angle Glaucoma or Ocular Hypertension
A Phase 1/2 Study to Evaluate the Safety and Efficacy of AGN-193408 SR in Participants With Open-Angle Glaucoma or Ocular Hypertension
About This Trial
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
Who May Be Eligible (Plain English)
Original Eligibility Criteria
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Treatments Being Tested
AGN-193408 SR
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.
Lumigan
Control Treatment in Fellow Eye Lumigan 0.01% is a topical eye drop that is a solution containing 0.1 mg/mL bimatoprost
Sham Administration
Needleless applicator contacting similar intracameral insertion location on eye as AGN-193408 SR.
Lumigan Vehicle
Vehicle eye drops (for masking) will be administered once daily in the evening starting on Day 1 in the study eye during Cohort 2.
AGN-193408 SR
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.
Sham Administration
Needleless applicator contacting similar insertion location on eye as AGN-193408 SR.
Lumigan Vehicle
Vehicle eye drops (for masking) will be administered once daily in the evening starting on Day 1 in the study eye during Cohort 3.