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NCT04149899 · ClinicalTrials.gov registry record · Phase 1
Safety and IOP-Lowering Effects of WB007
A Phase 1 study of Ocular Hypertension and Glaucoma, Primary Open Angle, sponsored by Bausch & Lomb Incorporated.
- Completed
- Registry status
- Phase 1
- Development phase
- 77
- Enrollment target
- 1
- Study location
NCT04149899: Completed Phase 1 study of Ocular Hypertension and Glaucoma, Primary Open Angle, sponsored by Bausch & Lomb Incorporated.
NCT04149899 is a Phase 1 study of Ocular Hypertension and Glaucoma, Primary Open Angle that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 77 participants, below the 277-participant average among 54 other Ocular Hypertension trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04149899, a Phase 1 study of Ocular Hypertension and Glaucoma, Primary Open Angle, has completed, sponsored by Bausch & Lomb Incorporated.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 77 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 an
Conditions Studied
Interventions
- DRUG WB007 0.05%
- DRUG WB007 0.15%
- DRUG WB007 0.4%
- DRUG Timolol 0.5%
Study Locations (1)
California
- Eye Research Foundation - Newport Beach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2019-11-14 |
| Est. Completion | 2022-12-14 |
| Phase | Phase 1 |
What the finished NCT04149899 record still lists
NCT04149899 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 277-participant average among 54 other Ocular Hypertension trials with a reported enrollment target (72% lower).
The record links to 2 conditions, with Ocular Hypertension appearing as the primary indexed condition, and to 4 interventions - of which WB007 0.05% is the first listed.
NCT04149899 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04149899 about?
NCT04149899 is a clinical study titled "Safety and IOP-Lowering Effects of WB007". 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 ...
What is the current status of trial NCT04149899?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 77 participants. The study started on 2019-11-14. Estimated completion is 2022-12-14.
What conditions does trial NCT04149899 study?
This clinical trial studies the following conditions: Ocular Hypertension, Glaucoma, Primary Open Angle.
What interventions are being tested in trial NCT04149899?
The interventions under investigation include: WB007 0.05% (DRUG), WB007 0.15% (DRUG), WB007 0.4% (DRUG), Timolol 0.5% (DRUG).
Who is sponsoring clinical trial NCT04149899?
This trial is sponsored by Bausch & Lomb Incorporated, which has 174 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04149899 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04149899's enrollment target sits among peer trials
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