A Phase 1/2 interventional study of AGN-193408 SR and Lumigan in Open-angle Glaucoma and Ocular Hypertension, sponsored by AbbVie. Active, not recruiting at 49 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by AbbVie · Phase 1/2, Interventional, and Treatment
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
929 studies on the registry are indexed under Glaucoma, Open-Angle; 122 are open to participants now.
This study's enrollment of 100 is above the median of 80 across 700 interventional studies indexed under Glaucoma, Open-Angle.
Browse Glaucoma, Open-Angle studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Anticipated use of corticosteroids in either eye except for permitted interventions or systemically during the study, or historical use prior to Baseline within:
The anticipated wearing of contact lenses in the study eye (Cohort 1) and both eyes (Cohorts 2 and 3) during the study that deviates from the following (contact lens wear is allowed during the study, but is to be temporarily discontinued before study visits, and before and after an Administration Day according to the following):
Single dose of AGN-193408 SR Dose A administered in the study eye on Day 1. One drop of Lumigan 0.01% administered in the non-study eye once daily every evening starting on Day 1.
Drug: AGN-193408 SR · Other: Lumigan
Single dose of AGN-193408 SR Dose B administered in the study eye on Day 1. One drop of Lumigan 0.01% administered in the non-study eye once daily every evening starting on Day 1.
Drug: AGN-193408 SR · Other: Lumigan
AGN-193408 SR Dose A (single dose on Day 1) + vehicle eye drops (once daily in the evening starting on Day 1) administered in the study eye. Lumigan (once daily in the evening starting on Day 1) + Sham AGN-193408 SR (single administration on Day 1) administered in the non-study eye.
Drug: AGN-193408 SR · Other: Lumigan · Other: Sham Administration · Other: Lumigan Vehicle
AGN-193408 SR Dose B (single dose on Day 1) + vehicle eye drops (once daily in the evening starting on Day 1) administered in the study eye. Lumigan (once daily in the evening starting on Day 1) + Sham AGN-193408 SR (single administration on Day 1) administered in the non-study eye.
Drug: AGN-193408 SR · Other: Lumigan · Other: Sham Administration · Other: Lumigan Vehicle
AGN-193408 SR Dose A (single dose on Day 1) + vehicle eye drops (once daily in the evening starting on Day 1) administered in the study eye. Lumigan (once daily in the evening starting on Day 1) + Sham AGN-193408 SR (single administration on Day 1) administered in the non-study eye.
Other: Lumigan · Drug: AGN-193408 SR · Other: Sham Administration · Other: Lumigan Vehicle
AGN-193408 SR Dose B (single dose on Day 1) + vehicle eye drops (once daily in the evening starting on Day 1) administered in the study eye. Lumigan (once daily in the evening starting on Day 1) + Sham AGN-193408 SR (single administration on Day 1) administered in the non-study eye.
Other: Lumigan · Drug: AGN-193408 SR · Other: Sham Administration · Other: Lumigan Vehicle
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
Also known as: Active Comparator
Needleless applicator contacting similar intracameral 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 2.
Also known as: Vehicle
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.
Also known as: Vehicle
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
Plan to share: Yes — AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Supporting information: Study protocol, Sap
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This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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