A Phase 1b Study of ONL1204 Ophthalmic Solution in Patients with Progressing Open Angle Glaucoma (NCT05160805) | Clinical Trial Compass
CompletedPhase 1
A Phase 1b Study of ONL1204 Ophthalmic Solution in Patients with Progressing Open Angle Glaucoma
Australia25 participantsStarted 2022-05-02
Plain-language summary
The purpose of this study is to demonstrate the safety and tolerability of ONL1204 Ophthalmic Solution in patients with progressing open angle glaucoma.
ONL1204 Ophthalmic Solution is a first-in-class inhibitor of fragment apoptosis stimulator (Fas) receptor-mediated cell death that has demonstrated protection of multiple retinal cell types in numerous preclinical models of retinal disease. Apoptosis of retinal ganglion cells is associated with progressive glaucoma. Nonclinical data on ONL1204 Ophthalmic Solution suggest that ONL1204 Ophthalmic Solution may inhibit the cell death pathways in these cells.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Males and females aged ≥18 years old
✓. Able and willing to give informed consent and attend study visits
✓. Controlled intraocular pressure (IOP) (≤21 mmHg) in both eyes for all previous 3 visits before Screening and at Screening in both eyes
✓. Prior to screening, 3 or more Humphrey Visual Field (HVF) tests (with acceptable reliability standards) or 3 or more Optical Coherence Tomography (OCT) studies of the study eye on record
✓. Open angle glaucoma that is progressing in the study eye
✓. HVF 24-2 at Screening with acceptable reliability standards and MD scores
Exclusion criteria
✕. Best Corrected Visual Acuity (BCVA) at Screening of ≤64 letters (Snellen equivalent of worse than 20/50)
✕. Severe open angle glaucoma
✕. Glaucoma due to non-open angle causes
What they're measuring
1
Safety and Tolerability of ONL1204 as assessed by AE reporting and clinical evaluations