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This will be a randomized non-dispensing study comparing the overnight corneal swelling of an eye while wearing no contact lens to the Ultra contract lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group 1 | Experimental | 1st overnight visit with no contact lens; 2nd overnight visit randomized to either left or right eye for B&L Investigational Contact Lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B&L Investigational Contact Lens | Device | The lens used in this study will be supplied by the Sponsor. All subjects will wear a -3.00D lens. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Central Corneal Thickness | Percent change in central corneal thickness from evening to morning (after 8 hours with lid closed) | 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Restore Central Corneal Thickness | Time (hours) to restore central corneal thickness to its baseline value after lens removal | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Steffen, OD, MS | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Bloomington | Indiana | 47405 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Group 1 | 1st overnight visit with no contact lens; 2nd overnight visit randomized to either left or right eye for B&L Investigational Contact Lens B&L Investigational Contact Lens: The lens used in this study will be supplied by the Sponsor. All subjects will wear a -3.00D lens. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Group 1 | 1st overnight visit with no contact lens; 2nd overnight visit randomized to either left or right eye for B&L Investigational Contact Lens B&L Investigational Contact Lens: The lens used in this study will be supplied by the Sponsor. All subjects will wear a -3.00D lens. |
| 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 | Percent Change in Central Corneal Thickness | Percent change in central corneal thickness from evening to morning (after 8 hours with lid closed) | Posted | Mean | Standard Deviation | milimeters | 8 hours |
|
|
2 days
Adverse events were not coded. Therefore, source vocabulary is not applicable.
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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 | Study Group 1 | 1st overnight visit with no contact lens; 2nd overnight visit randomized to either left or right eye for B&L Investigational Contact Lens B&L Investigational Contact Lens: The lens used in this study will be supplied by the Sponsor. All subjects will wear a -3.00D lens. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch Health | 585-338-6399 | robert.steffen@bausch.com |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
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| Secondary | Time to Restore Central Corneal Thickness | Time (hours) to restore central corneal thickness to its baseline value after lens removal | Posted | Number | percentage of participants | 48 hours |
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| 0 |
| 38 |
| 0 |
| 38 |
Contact sponsor directly for details.
| 2 hours |
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| 3 hours |
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| 4 hours |
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| >4 hours |
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