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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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The current study aims to systematically investigate the diurnal variation in the optical quality of soft contact lenses on eye throughout the day. Subject reported quality of vision will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lotrafilcon B | Placebo Comparator |
| |
| Lotrafilcon B Hydraluxe | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lotrafilcon B | Device | commercially available contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Higher Order Aberrations | Higher-order Root Mean Squared (RMS) over a 3mm pupil; difference in RMS error between 0 and 12 hour timepoints; averaged across all subjects | 0-12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Stability of Vision Rating | Subjects are asked to rate their stability of vision on a numeric rating scale (0, poor to 100 excellent) (Kollbaum 2012). The difference between time 0 and time 12 hours is reported for all subjects (negative number represents a decrease in stability of vision) | 0-12 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Clinical Optics Research Lab | Bloomington | Indiana | 47405 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lotrafilcon B First, Then Lotrafilcon B With Hydraluxe | First intervention (2+/-1day) Second intervention (2+/-1day) |
| FG001 | Lotrafilcon B With Hydraluxe First, Then Lotrafilcon B | First intervention (2+/-1day) Second intervention (2+/-1day) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lotrafilcon B First, Then Lotrafilcon B With Hydraluxe | First intervention (2+/-1day) Second intervention (2+/-1day) |
| BG001 | Lotrafilcon B With Hydraluxe First, Then Lotrafilcon B |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Higher Order Aberrations | Higher-order Root Mean Squared (RMS) over a 3mm pupil; difference in RMS error between 0 and 12 hour timepoints; averaged across all subjects | Posted | Mean | Standard Deviation | microns | 0-12 hours |
|
|
through study completion, an average of 2 weeks
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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 | Lotrafilcon B | During wear of Lotrafilcon B, including all subjects, despite randomization |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pete Kollbaum | IU School of Optometry | 812-856-0108 | kollbaum@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 5, 2018 | Jan 23, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006956 | Hyperopia |
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| lotrafilcon B with Hydraluxe | Device | commercially available contact lens |
|
| Image Quality Metrics |
Root Mean Squared (RMS) wavefront error over a 3mm pupil; difference in RMS error between 0 and 12 hour timepoints; averaged across all subjects |
| 0-12 hours |
First intervention (2+/-1day) Second intervention (2+/-1day)
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Subjective Stability of Vision Rating | Subjects are asked to rate their stability of vision on a numeric rating scale (0, poor to 100 excellent) (Kollbaum 2012). The difference between time 0 and time 12 hours is reported for all subjects (negative number represents a decrease in stability of vision) | Posted | Mean | Standard Deviation | score on a scale | 0-12 hours |
|
|
|
|
| Secondary | Image Quality Metrics | Root Mean Squared (RMS) wavefront error over a 3mm pupil; difference in RMS error between 0 and 12 hour timepoints; averaged across all subjects | Posted | Mean | Standard Deviation | microns | 0-12 hours |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Lotrafilcon B With Hydraluxe | During wear of Lotrafilcon B With Hydraluxe, including all subjects, despite randomization | 0 | 12 | 0 | 12 | 0 | 12 |
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| 0.4679 |
| Other |
Friedman test |