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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 (Period 1): WB007 0.05% | Experimental | WB007 0.05%, single dose to study eye on Day 1 |
|
| Part 1 (Period 2): WB007 0.15% | Experimental | WB007 0.15%, single dose to study eye on Day 1 |
|
| Part 1 (Period 3): WB007 0.4% | Experimental | WB007 0.4%, single dose to study eye on Day 1 |
|
| Part 2: WB007 0.15% | Experimental | WB007 0.15%, dosed twice daily for 14 days |
|
| Part 2: WB007 0.4% | Experimental | WB007 0.4%, dosed twice daily for 14 days |
|
| Part 2: Timolol 0.5% | Active Comparator | Timolol 0.5%, dosed twice daily for 14 days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WB007 0.05% | Drug | WB007 Ophthalmic Solution 0.05% |
| |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Wirta, MD | Eye Research Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Research Foundation | Newport Beach | California | 92663 | United States |
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This was a 2-part study:
Part 1: 18 subjects were enrolled and completed study. Based on results from Part 1, two WB007 doses were selected for Part 2.
Part 2: 59 subjects were enrolled and completed the study.
No subjects discontinued the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1 (Period 1): WB007 0.05% | WB007 0.05%, single dose to study eye on Day 1 |
| FG001 | Part 1 (Period 2): WB007 0.15% | WB007 0.15%, single dose to study eye on Day 1 |
| FG002 | Part 1 (Period 3): WB007 0.4% | WB007 0.4%, single dose to study eye on Day 1 |
| FG003 | Part 2: WB007 0.15% | WB007 0.15%, dosed twice daily for 14 days |
| FG004 | Part 2: WB007 0.4% | WB007 0.4%, dosed twice daily for 14 days |
| FG005 | Part 2: Timolol 0.5% | Timolol 0.5%, dosed twice daily for 14 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1 (Period 1): WB007 0.05% | WB007 0.05%, single dose to study eye on Day 1 |
| BG001 | Part 1 (Period 2): WB007 0.15% | WB007 0.15%, single dose to study eye on Day 1 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Modified Intent-to-Treat Population (mITT) with Last Observation Carried Forward: the mITT population consisted of all randomized and treated subjects who provided IOP data at baseline and had at least one post-baseline IOP assessment. | Posted | Mean | Standard Deviation | millimeters of mercury (mm Hg) | Baseline, Day 14 |
|
Screening up to Baseline (up to 6 weeks) Part 1: Post-Baseline to Day 2 Part 2: Post-Baseline to Day 14
Adverse Events are reported for all treated subjects.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1 (Period 1): WB007 0.05% | WB007 0.05%, single dose to study eye on Day 1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Instillation Site Pain | General disorders | MedDRA 20.1 | Non-systematic Assessment | General Disorders and Administration Site Conditions |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development | Bausch & Lomb Incorporated | 949-416-1194 | kevin.kerr@bausch.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 30, 2021 | Feb 26, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 2, 2021 | Feb 26, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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Part 1 - Open-labelled, single dose, 3-period dose escalation; Part 2 - Double-masked, randomized, parallel comparison
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Part 1 - not masked; Part 2 - Double-masked - neither investigator, study staff nor study participant were aware of treatment assignment
| 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 |
|
| Baseline, Day 14 |
| BG002 | Part 1 (Period 3): WB007 0.4% | WB007 0.4%, single dose to study eye on Day 1 |
| BG003 | Part 2: WB007 0.15% | WB007 0.15% dosed twice daily for 14 days |
| BG004 | Part 2: WB007 0.4% | WB007 0.4% dosed twice daily for 14 days |
| BG005 | Part 2: Timolol 0.5% | Timolol 0.5%, dosed twice daily for 14 days |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 |
| Part 2: WB007 0.15% |
WB007 0.15%, dosed twice daily for 14 days. |
| OG001 | Part 2: WB007 0.4% | WB007 0.4%, dosed twice daily for 14 days. |
| OG002 | Part 2: Timolol 0.5% | Timolol 0.5%, dosed twice daily for 14 days. |
|
|
|
| Secondary | 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. | Modified Intent-to-Treat Population (mITT) with Last Observation Carried Forward: the mITT population consisted of all randomized and treated subjects who provided IOP data at baseline and had at least one post-baseline IOP assessment. | Posted | Mean | Standard Deviation | millimeters of mercury (mm Hg) | Baseline, Day 14 |
|
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Part 1 (Period 2): WB007 0.15% | WB007 0.15%, single dose to study eye on Day 1 | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | Part 1 (Period 3): WB007 0.4% | WB007 0.4%, single dose to study eye on Day 1 | 0 | 6 | 0 | 6 | 5 | 6 |
| EG003 | Part 2: WB007 0.15% | WB007 0.15%, dosed twice daily for 14 days | 0 | 23 | 0 | 23 | 15 | 23 |
| EG004 | Part 2: WB007 0.4% | WB007 0.4%, dosed twice daily for 14 days | 0 | 24 | 0 | 24 | 17 | 24 |
| EG005 | Part 2: Timolol 0.5% | Timolol 0.5%, dosed twice daily for 14 days | 0 | 12 | 0 | 12 | 2 | 12 |
|
| Instillation Site Burn | General disorders | MedDRA 20.1 | Non-systematic Assessment | General Disorders and Administration Site Conditions |
|
| Punctate Keratitis | Eye disorders | MedDRA 20.1 | Systematic Assessment |
|
The investigator shall agree to submit all manuscripts or abstracts to the sponsor for review before submission. Authorship and manuscript composition will reflect joint cooperation between the investigator(s) and sponsor personnel; authorship will be established by mutual agreement, and in line with ICMJE authorship requirements. No individual publications will be allowed prior to completion of the final report of the multicenter study, except as agreed with sponsor.
|
| Baseline, Hour 4 |
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| Baseline, Hour 8 |
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| Day 14, Hour 0 |
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| Day 14, Hour 2 |
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| Day 14, Hour 4 |
|
| Day 14, Hour 8 |
|
A pairwise treatment group comparison was performed versus timolol ophthalmic solution 0.5%. A 2-sided 95% confidence interval (CI) for the treatment difference (WB007 minus Timolol) was constructed based on an ANCOVA model. If WB007 was determined to be non-inferior to Timolol, an attempt to show superiority of WB007 over Timolol was made.
| The mean IOP for WB007 0.4% was compared to Timolol 0.5% at Day 14, Hour 2, the timepoint for the peak effect of Timolol 0.5% and the primary efficacy timepoint for the study. | ANCOVA | 0.520 | The p-value (2-sided) for superiority was not adjusted for multiple comparisons. | Mean Difference (Final Values) | -0.42 | 2-Sided | 95 | -1.73 | 0.89 | The estimated treatment difference is based on the least-square means from the ANCOVA model. | Non-Inferiority | A pairwise treatment group comparison was performed versus timolol ophthalmic solution 0.5%. A 2-sided 95% confidence interval (CI) for the treatment difference (WB007 minus Timolol) was constructed based on an ANCOVA model. If WB007 was determined to be non-inferior to Timolol, an attempt to show superiority of WB007 over Timolol was made. |
| The mean IOP for WB007 0.15% was compared to Timolol 0.5% at Day 14, Hour 2, the timepoint for the peak effect of Timolol 0.5% and the primary efficacy timepoint for the study. | ANOVA | The ANOVA model has the treatment group as the main effect. | 0.283 | The p-value (2-sided) for superiority was not adjusted for multiple comparisons. | Mean Difference (Final Values) | -0.84 | 2-Sided | 95 | -2.39 | 0.71 | The estimated treatment difference is based on the least-square means from the ANOVA model. | Non-Inferiority | A pairwise treatment group comparison was performed versus timolol ophthalmic solution 0.5%. A 2-sided 95% confidence interval (CI) for the treatment difference (WB007 minus Timolol) was constructed based on an ANOVA model. If WB007 was determined to be non-inferior to Timolol, an attempt to show superiority of WB007 over Timolol was made. |
| The mean IOP for WB007 0.4% was compared to Timolol 0.5% at Day 14, Hour 2, the timepoint for the peak effect of Timolol 0.5% and the primary efficacy timepoint for the study. | ANOVA | The ANOVA model has the treatment group as the main effect. | 0.189 | The p-value (2-sided) for superiority was not adjusted for multiple comparisons. | Mean Difference (Final Values) | -1.02 | 2-Sided | 95 | -2.56 | 0.52 | The estimated treatment difference is based on the least-square means from the ANOVA model. | Non-Inferiority | A pairwise treatment group comparison was performed versus timolol ophthalmic solution 0.5%. A 2-sided 95% confidence interval (CI) for the treatment difference (WB007 minus Timolol) was constructed based on an ANOVA model. If WB007 was determined to be non-inferior to Timolol, an attempt to show superiority of WB007 over Timolol was made. |