Safety and IOP-Lowering Effects of WB007

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1/2a Assessment of WB007 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension

Conditions
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Glaucoma, Primary Open Angle, Ocular Hypertension

Intervention / Treatment
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* Drug: WB007 0.05%
* Drug: WB007 0.15%
* Drug: WB007 0.4%
* Drug: Timolol 0.5%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Part 1 - Open-labelled, single dose, 3-period dose escalation; Part 2 - Double-masked, randomized, parallel comparison
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1 (Period 1): WB007 0.05%<br>WB007 0.05%, single dose to study eye on Day 1 | Drug: WB007 0.05%<br>* WB007 Ophthalmic Solution 0.05%<br>|
| Experimental: Part 1 (Period 2): WB007 0.15%<br>WB007 0.15%, single dose to study eye on Day 1 | Drug: WB007 0.15%<br>* WB007 Ophthalmic Solution 0.15%<br>|
| Experimental: Part 1 (Period 3): WB007 0.4%<br>WB007 0.4%, single dose to study eye on Day 1 | Drug: WB007 0.4%<br>* WB007 Ophthalmic Solution 0.4%<br>|
| Experimental: Part 2: WB007 0.15%<br>WB007 0.15%, dosed twice daily for 14 days | Drug: WB007 0.15%<br>* WB007 Ophthalmic Solution 0.15%<br>|
| Experimental: Part 2: WB007 0.4%<br>WB007 0.4%, dosed twice daily for 14 days | Drug: WB007 0.4%<br>* WB007 Ophthalmic Solution 0.4%<br>|
| Active Comparator: Part 2: Timolol 0.5%<br>Timolol 0.5%, dosed twice daily for 14 days. | Drug: Timolol 0.5%<br>* Timolol Maleate 0.5% Ophthalmic Solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part 2: Mean Change From Baseline in Intraocular Pressure (IOP) at Day 14 - Study Eye | IOP is a measurement of the pressure inside the eye and was measured using Goldmann applanation tonometry. Study participants used the study medications in both eyes for 14 days. One eye was designated as the Study Eye at baseline: eyes that met inclusion and exclusion criteria. If both eyes were eligible, the study eye was the eye with higher IOP at Baseline at Hour 0. If both eyes had the same IOP at this timepoint, the right eye was designated as the study eye. IOP was measured at Baseline and Day 14 at Hours 0, 2, 4 and 8. The primary endpoint was the mean change from baseline IOP at Day 14, Hour 2, the timepoint of the peak effect of timolol. | Baseline, Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part 2: Mean IOP at Day 14 - Study Eye | IOP is a measurement of the pressure inside the eye and was measured using Goldmann applanation tonometry. Study participants used the study medications in both eyes for 14 days. One eye was designated as the Study Eye at baseline: eyes that met inclusion and exclusion criteria. If both eyes were eligible, the study eye was the eye with higher IOP at Baseline at Hour 0. If both eyes had the same IOP at this timepoint, the right eye was designated as the study eye. IOP was measured at Baseline and Day 14 at Hours 0, 2, 4 and 8. The primary timepoint was at Day 14, Hour 2, the timepoint of the peak effect of timolol. | Baseline, Day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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POAG, OHT, Primary open-angle glaucoma, ocular hypertension