Glaucoma, Primary Open AnglePhase 1/2NCT04149899
Safety and IOP-Lowering Effects of WB007
A Phase 1/2 study testing WB007 0.05%, WB007 0.15% and WB007 0.4% in people with Glaucoma, Primary Open Angle and Ocular Hypertension, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Primary Open Angle, Ocular Hypertension
- What is being tested?
- WB007 0.05%, WB007 0.15% and WB007 0.4%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2019to 14 Dec 2022
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ocular hypertension or primary open-angle glaucoma in each eye
Who cannot join
- History of orthostatic hypotension
- Any active ocular disease
- Anticipated wearing of contact lenses during study
- Contraindication to pupil dilatation
Trial locations and contacts
1 site in 1 country.
United States1 site
Eye Research Foundation
Newport Beach, California, 92663
About this study
Official title: A Phase 1/2a Assessment of WB007 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension
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.
- Conditions
- Glaucoma, Primary Open Angle, Ocular Hypertension
- Being tested
- WB007 0.05%, WB007 0.15%, WB007 0.4%, Timolol 0.5%
- Keywords
- POAG, OHT, Primary open-angle glaucoma, ocular hypertension
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WB007 0.05%Drug
WB007 Ophthalmic Solution 0.05%
WB007 0.15%Drug
WB007 Ophthalmic Solution 0.15%
WB007 0.4%Drug
WB007 Ophthalmic Solution 0.4%
Timolol 0.5%Drug
Timolol Maleate 0.5% Ophthalmic Solution
| Study group | Role | What they receive |
|---|---|---|
| Part 1 (Period 1): WB007 0.05% | Experimental | WB007 0.05%, single dose to study eye on Day 1 Receives: Drug: WB007 0.05% |
| Part 1 (Period 2): WB007 0.15% | Experimental | WB007 0.15%, single dose to study eye on Day 1 Receives: Drug: WB007 0.15% |
| Part 1 (Period 3): WB007 0.4% | Experimental | WB007 0.4%, single dose to study eye on Day 1 Receives: Drug: WB007 0.4% |
| Part 2: WB007 0.15% | Experimental | WB007 0.15%, dosed twice daily for 14 days Receives: Drug: WB007 0.15% |
| Part 2: WB007 0.4% | Experimental | WB007 0.4%, dosed twice daily for 14 days Receives: Drug: WB007 0.4% |
| Part 2: Timolol 0.5% | Active comparator | Timolol 0.5%, dosed twice daily for 14 days. Receives: Drug: Timolol 0.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Day 14
Secondary outcomes (1)
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.
Measured: Baseline, Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start14 Nov 2019
- Primary completion31 Jan 2021
- Study completion14 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Glaucoma, Primary Open AngleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part 1 - Open-labelled, single dose, 3-period dose escalation; Part 2 - Double-masked, randomized, parallel comparison
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Wirta, MD, Principal investigator, Eye Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04149899
- Sponsor's protocol ID
- WB007-001
- Status last verified
- Mar 2025
- First submitted
- 30 Oct 2019
- Last updated
- 27 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a Assessment of WB007 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT04149899
- Acronym / sponsor ID
- WB007-001
- Conditions
- Glaucoma, Primary Open Angle, Ocular Hypertension
- Keywords
- POAG, OHT, Primary open-angle glaucoma, ocular hypertension
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2019 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 14 Dec 2022 (actual)
- First posted
- 4 Nov 2019 (actual)
- Results
- Posted 24 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Part 1 - Open-labelled, single dose, 3-period dose escalation; Part 2 - Double-masked, randomized, parallel comparison
| Arm | Type | Receives |
|---|---|---|
| Part 1 (Period 1): WB007 0.05% | Experimental | Drug: WB007 0.05%WB007 0.05%, single dose to study eye on Day 1 |
| Part 1 (Period 2): WB007 0.15% | Experimental | Drug: WB007 0.15%WB007 0.15%, single dose to study eye on Day 1 |
| Part 1 (Period 3): WB007 0.4% | Experimental | Drug: WB007 0.4%WB007 0.4%, single dose to study eye on Day 1 |
| Part 2: WB007 0.15% | Experimental | Drug: WB007 0.15%WB007 0.15%, dosed twice daily for 14 days |
| Part 2: WB007 0.4% | Experimental | Drug: WB007 0.4%WB007 0.4%, dosed twice daily for 14 days |
| Part 2: Timolol 0.5% | Active comparator | Drug: Timolol 0.5%Timolol 0.5%, dosed twice daily for 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ocular hypertension or primary open-angle glaucoma in each eye
Key exclusion criteria (4 listed)
- History of orthostatic hypotension
- Any active ocular disease
- Anticipated wearing of contact lenses during study
- Contraindication to pupil dilatation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WB007 0.05%WB007 Ophthalmic Solution 0.05% | Drug | Part 1 (Period 1): WB007 0.05% |
| WB007 0.15%WB007 Ophthalmic Solution 0.15% | Drug | Part 1 (Period 2): WB007 0.15%, Part 2: WB007 0.15% |
| WB007 0.4%WB007 Ophthalmic Solution 0.4% | Drug | Part 1 (Period 3): WB007 0.4%, Part 2: WB007 0.4% |
| Timolol 0.5%Timolol Maleate 0.5% Ophthalmic Solution | Drug | Part 2: Timolol 0.5% |
Primary outcome
Part 2: Mean Change From Baseline in Intraocular Pressure (IOP) at Day 14 - Study Eye
Time frame: Baseline, Day 14
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.
1 secondary outcome
Part 2: Mean IOP at Day 14 - Study Eye
Time frame: Baseline, Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Wirta, MD principal investigator
Eye Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing WB007 0.05%, WB007 0.15% and WB007 0.4% in people with Glaucoma, Primary Open Angle and Ocular Hypertension, run by Bausch & Lomb Incorporated at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 2: Mean Change From Baseline in Intraocular Pressure (IOP) at Day 14 - Study Eye (time frame: Baseline, Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.