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This study is to evaluate the product performance of the investigational LD127025 MF mid add soft contact lens compared to CIBA Vision's Air Optix Aqua MF MED add soft contact lenses when used among currently adapted soft contact lens wearers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LD127025 MF | Experimental | Mid add daily disposable soft contact lens worn on a daily wear basis for 1 week. |
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| Air Optix Aqua MF | Active Comparator | Medium add daily disposable soft contact lens worn on a daily wear basis for one week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LD127025 MF | Device | At Visit 1, one-half of the subjects will be randomized to receive the investigational soft contact lens, after approximately one week of wearing the first lens type, the subjects will return for the 1-Week Crossover Visit (Visit 2) for an exam, and to determine if the subject remains eligible to continue in the next phase of the study with the control soft contact lens. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Visual Acuity | Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR). | At 1 Week follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms/Complaints | Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints. | At 1 Week follow up |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Stefffen | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb Incorporated | Rochester | New York | 14609 | United States |
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There were 146 participants (292 eyes) were enrolled in this study. One-half of the participants were randomized to receive the investigational lens, and the other half to the control lens. After one week, the participant crossed over to the second lens type for one week.
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| ID | Title | Description |
|---|---|---|
| FG000 | LD127025 MF Then Air Optix Aqua MF | LD127025 MF and then Air Optix Aqua MF after 1 week |
| FG001 | Air Optix Aqua MF Then LD127025 MF | Air Optix Aqua MF and then LD127025 MF after 1 week |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Demographics were reported for all eligible, dispensed participants. There was one participant that was not eligible for the study, and thus was excluded.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Enrolled | Overall participants enrolled. |
| 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 |
| 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 Visual Acuity | Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR). | Eligible, dispensed eyes assessed for visual acuity are included in the analysis population. | Posted | Least Squares Mean | Standard Deviation | logMAR | At 1 Week follow up | eyes | eyes |
|
2 weeks
Adverse events were not coded. Therefore, source vocabulary is not applicable. Safety data were reported for all eligible, dispensed participants. There was one participant that was not eligible for the study, and thus was excluded.
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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 | LD127025 MF | Mid add daily disposable soft contact lens worn on a daily wear basis for 1 week. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch Health | robert.steffen@bausch.com |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Air Optix Aqua MF | Device | At Visit 1, one-half of the subjects will be randomized to receive the control soft contact lens, after approximately one week of wearing the first lens type, the subjects will return for the 1-Week Crossover Visit (Visit 2) for an exam, and to determine if the subject remains eligible to continue in the next phase of the study with the investigational soft contact lens. |
|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| eyes |
|
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| Secondary | Symptoms/Complaints | Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints. | Eligible, dispensed eyes assessed for symptoms/complaints are included in the analysis population. | Posted | Least Squares Mean | Standard Deviation | score on a scale | At 1 Week follow up | eyes | eyes |
|
|
|
| 0 |
| 145 |
| 0 |
| 145 |
| EG001 | Air Optix Aqua MF | Medium add daily disposable soft contact lens worn on a daily wear basis for one week. | 0 | 145 | 0 | 145 |
Contact sponsor directly for details.
| Comfort at end of day |
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| Overall comfort |
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| Ease of handling/insertion |
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| Ease of handling/removal |
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| Dryness |
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| Itchiness |
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| Redness |
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| Overall impression |
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| Distance vision |
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| Vision at intermediate distance |
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| Vision at near distance |
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| Overall vision |
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