Phase 2
Completed N=77
Safety and IOP-Lowering Effects of WB007
Glaucoma, Primary Open Angle · Hypertension
Source: ClinicalTrials.gov NCT04149899 ↗
Enrolled (actual)
77
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcomePrimary: Part 2: Mean Change From Baseline in Intraocular Pressure (IOP) at Day 14 - Study Eye — 26.3; 26.1; 27.1; 24.8 millimeters of mercury (mm Hg) — p=<0.001
Summary
The study evaluated the safety and IOP-lowering effects of WB007 in adults with primary open-angle glaucoma or ocular hypertension in both eyes. This was a 2-part study. Part 1 was a 3-period dose escalation that evaluated 3 concentrations of WB007 ophthalmic solution following a single dose in one eye. Part 2 was a randomized, double-masked, parallel comparison that evaluated two concentrations of WB007 (selected based on Part 1 results) in both eyes compared with timolol 0.5% for 14 days.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 2: Mean Change From Baseline in Intraocular Pressure (IOP) at Day 14 - Study Eye |
26.3; 26.1; 27.1; 24.8; 24.8; 26.7 | <0.001 sig |
| SECONDARY Part 2: Mean IOP at Day 14 - Study Eye |
26.3; 26.1; 27.1; 24.8; 24.8; 26.7 | 0.828 |
Eligibility Criteria
Inclusion Criteria
- Ocular hypertension or primary open-angle glaucoma in each eye
Exclusion Criteria
- History of orthostatic hypotension
- Any active ocular disease
- Anticipated wearing of contact lenses during study
- Contraindication to pupil dilatation
Data sourced from ClinicalTrials.gov (NCT04149899). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.