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The objective of this study is to identify the concentration and daily dosing frequency of BOL-303242-X ophthalmic suspension in treating dry eye syndrome over a 12 week dosing period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.3% BOL-303242-X ophthalmic suspension | Experimental | 0.3% BOL-303242-X ophthalmic suspension |
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| 2% BOL-303242-X ophthalmic suspension | Experimental | 2% BOL-303242-X ophthalmic suspension |
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| Vehicle | Placebo Comparator | Vehicle twice daily (BID) |
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| 1% BOL-303242-X ophthalmic suspension | Experimental | 1% BOL-303242-X ophthalmic suspension |
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| 2% BOL-303242-X ophthalmic suspension in the morning | Experimental | 2% BOL-303242-X ophthalmic suspension in the morning (AM) and vehicle in the afternoon (PM) |
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| 2% BOL-303242-X ophthalmic suspension PM | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.3% BOL-303242-X ophthalmic suspension | Drug | 0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Corneal Staining Score | Total corneal staining score was calculated by adding the individual grades from 5 regions of the corneal surface (1: Central; 2: Superior; 3: Temporal; 4: Nasal; 5: Inferior). Grade 0 = none and Grade 3 = severe. The minimum total score possible was 0 and the maximum total score possible was 15. Higher scores indicated worse outcome. | 12 weeks |
| Mean Worst Visual Analog Scale(VAS) Dry Eye Symptom | Each symptom (ocular discomfort, dryness, grittiness, and stinging) was assessed to the nearest millimeter on a 0 - 10 cm Visual Analog Scale (VAS) by the subject. The worst VAS dry eye symptom was utilized in the analysis. The minimum for the worst symptom was 0 and the maximum for the worst symptom was 10. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tuyen Ong, MD | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb | Rochester | New York | 14609 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 2% BOL-303242-X Ophthalmic Suspension | 2% BOL-303242-X ophthalmic suspension 2% BOL-303242-X ophthalmic suspension: 2% BOL-303242-X ophthalmic suspension BID for 12 weeks. |
| FG001 | 2% BOL-303242-X Ophthalmic Suspension in the Morning |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Vehicle in the AM and 2% BOL-303242-X ophthalmic suspension in the PM. |
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| 2% BOL-303242-X ophthalmic suspension | Drug | 2% BOL-303242-X ophthalmic suspension BID for 12 weeks. |
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| Placebo Comparator: Vehicle | Drug | Placebo Comparator: Vehicle BID for 12 weeks. |
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| 1% BOL-303242-X ophthalmic suspension | Drug | 1% BOL-303242-X ophthalmic suspension BID for 12 weeks. |
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| 2% BOL-303242-X ophthalmic suspension AM | Drug | 2% BOL-303242-X ophthalmic suspension once daily (QD) AM and vehicle QD in PM for 12 weeks. |
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| 2% BOL-303242-X ophthalmic suspension PM | Drug | Vehicle QD AM and 2% BOL-303242-X ophthalmic suspension QD in PM for 12 weeks. |
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2% BOL-303242-X ophthalmic suspension in the morning (AM) and vehicle in the afternoon (PM) 2% BOL-303242-X ophthalmic suspension AM: 2% BOL-303242-X ophthalmic suspension once daily (QD) AM and vehicle QD in PM for 12 weeks. |
| FG002 | 2% BOL-303242-X Ophthalmic Suspension PM | Vehicle in the AM and 2% BOL-303242-X ophthalmic suspension in the PM. 2% BOL-303242-X ophthalmic suspension PM: Vehicle QD AM and 2% BOL-303242-X ophthalmic suspension QD in PM for 12 weeks. |
| FG003 | 1% BOL-303242-X Ophthalmic Suspension | 1% BOL-303242-X ophthalmic suspension 1% BOL-303242-X ophthalmic suspension: 1% BOL-303242-X ophthalmic suspension BID for 12 weeks. |
| FG004 | 0.3% BOL-303242-X Ophthalmic Suspension | 0.3% BOL-303242-X ophthalmic suspension 0.3% BOL-303242-X ophthalmic suspension: 0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks. |
| FG005 | Vehicle | Vehicle twice daily (BID) Placebo Comparator: Vehicle: Placebo Comparator: Vehicle BID for 12 weeks. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 2% BOL-303242-X Ophthalmic Suspension | 2% BOL-303242-X ophthalmic suspension 2% BOL-303242-X ophthalmic suspension: 2% BOL-303242-X ophthalmic suspension BID for 12 weeks. |
| BG001 | 2% BOL-303242-X Ophthalmic Suspension in the Morning | 2% BOL-303242-X ophthalmic suspension in the morning (AM) and vehicle in the afternoon (PM) 2% BOL-303242-X ophthalmic suspension AM: 2% BOL-303242-X ophthalmic suspension once daily (QD) AM and vehicle QD in PM for 12 weeks. |
| BG002 | 2% BOL-303242-X Ophthalmic Suspension PM | Vehicle in the AM and 2% BOL-303242-X ophthalmic suspension in the PM. 2% BOL-303242-X ophthalmic suspension PM: Vehicle QD AM and 2% BOL-303242-X ophthalmic suspension QD in PM for 12 weeks. |
| BG003 | 1% BOL-303242-X Ophthalmic Suspension | 1% BOL-303242-X ophthalmic suspension 1% BOL-303242-X ophthalmic suspension: 1% BOL-303242-X ophthalmic suspension BID for 12 weeks. |
| BG004 | 0.3% BOL-303242-X Ophthalmic Suspension | 0.3% BOL-303242-X ophthalmic suspension 0.3% BOL-303242-X ophthalmic suspension: 0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks. |
| BG005 | Vehicle | Vehicle twice daily (BID) Placebo Comparator: Vehicle: Placebo Comparator: Vehicle BID for 12 weeks. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Mean Corneal Staining Score | Total corneal staining score was calculated by adding the individual grades from 5 regions of the corneal surface (1: Central; 2: Superior; 3: Temporal; 4: Nasal; 5: Inferior). Grade 0 = none and Grade 3 = severe. The minimum total score possible was 0 and the maximum total score possible was 15. Higher scores indicated worse outcome. | Randomized participants with Week 12 results were included, with no imputation of missing data at Week 12. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
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| Primary | Mean Worst Visual Analog Scale(VAS) Dry Eye Symptom | Each symptom (ocular discomfort, dryness, grittiness, and stinging) was assessed to the nearest millimeter on a 0 - 10 cm Visual Analog Scale (VAS) by the subject. The worst VAS dry eye symptom was utilized in the analysis. The minimum for the worst symptom was 0 and the maximum for the worst symptom was 10. | Randomized participants with Week 12 results were included, with no imputation of missing data at Week 12. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
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12 weeks
The safety population included participants who received at least 1 dose of study drug. Participants confirmed to have never took a dose of study drug were excluded from safety analyses. Of the randomized participants, there was one 2% BOL-303242-X Ophthalmic Suspension participant, one 2% BOL-303242-X Ophthalmic Suspension PM participant, one 1% BOL-303242-X Ophthalmic Suspension participant, and 2 Vehicle participants who did not take at least one dose of study drug.
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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 | 2% BOL-303242-X Ophthalmic Suspension | 2% BOL-303242-X ophthalmic suspension 2% BOL-303242-X ophthalmic suspension: 2% BOL-303242-X ophthalmic suspension BID for 12 weeks. | 0 | 67 | 1 | 67 | ||
| EG001 | 2% BOL-303242-X Ophthalmic Suspension in the Morning | 2% BOL-303242-X ophthalmic suspension in the morning (AM) and vehicle in the afternoon (PM) 2% BOL-303242-X ophthalmic suspension AM: 2% BOL-303242-X ophthalmic suspension once daily (QD) AM and vehicle QD in PM for 12 weeks. | 0 | 37 | 2 | 37 | ||
| EG002 | 2% BOL-303242-X Ophthalmic Suspension PM | Vehicle in the AM and 2% BOL-303242-X ophthalmic suspension in the PM. 2% BOL-303242-X ophthalmic suspension PM: Vehicle QD AM and 2% BOL-303242-X ophthalmic suspension QD in PM for 12 weeks. | 0 | 34 | 1 | 34 | ||
| EG003 | 1% BOL-303242-X Ophthalmic Suspension | 1% BOL-303242-X ophthalmic suspension 1% BOL-303242-X ophthalmic suspension: 1% BOL-303242-X ophthalmic suspension BID for 12 weeks. | 0 | 73 | 2 | 73 | ||
| EG004 | 0.3% BOL-303242-X Ophthalmic Suspension | 0.3% BOL-303242-X ophthalmic suspension 0.3% BOL-303242-X ophthalmic suspension: 0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks. | 0 | 69 | 3 | 69 | ||
| EG005 | Vehicle | Vehicle twice daily (BID) Placebo Comparator: Vehicle: Placebo Comparator: Vehicle BID for 12 weeks. | 0 | 71 | 5 | 71 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
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Contact sponsor directly for details.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch Health | susan.harris@bauschhealth.com |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Male |
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| OG003 | 1% BOL-303242-X Ophthalmic Suspension | 1% BOL-303242-X ophthalmic suspension 1% BOL-303242-X ophthalmic suspension: 1% BOL-303242-X ophthalmic suspension BID for 12 weeks. |
| OG004 | 0.3% BOL-303242-X Ophthalmic Suspension | 0.3% BOL-303242-X ophthalmic suspension 0.3% BOL-303242-X ophthalmic suspension: 0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks. |
| OG005 | Vehicle | Vehicle twice daily (BID) Placebo Comparator: Vehicle: Placebo Comparator: Vehicle BID for 12 weeks. |
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