Safety and IOP-Lowering Effects of WB007

Bausch + Lomb

Status and phase: Completed; Phase 2; Phase 1

Conditions: Glaucoma, Primary Open Angle; Ocular Hypertension

Treatments: Drug: WB007 0.4%; Drug: Timolol 0.5%; Drug: WB007 0.05%; Drug: WB007 0.15%

Study type: Interventional

Funder types: Industry

Identifiers

NCT04149899

WB007-001

Details and patient eligibility

About

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.

Enrollment: 77 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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77 participants in 6 patient groups

Part 1 (Period 1): WB007 0.05%

Experimental group

Description:

WB007 0.05%, single dose to study eye on Day 1

Treatment:

Drug: WB007 0.05%

Part 1 (Period 2): WB007 0.15%

Experimental group

Description:

WB007 0.15%, single dose to study eye on Day 1

Treatment:

Drug: WB007 0.15%

Part 1 (Period 3): WB007 0.4%

Experimental group

Description:

WB007 0.4%, single dose to study eye on Day 1

Treatment:

Drug: WB007 0.4%

Part 2: WB007 0.15%

Experimental group

Description:

WB007 0.15%, dosed twice daily for 14 days

Treatment:

Drug: WB007 0.15%

Part 2: WB007 0.4%

Experimental group

Description:

WB007 0.4%, dosed twice daily for 14 days

Treatment:

Drug: WB007 0.4%

Part 2: Timolol 0.5%

Active Comparator group

Description:

Timolol 0.5%, dosed twice daily for 14 days.

Treatment:

Drug: Timolol 0.5%