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The primary objective of this study is to evaluate the overall clinical performance of an investigational silicone hydrogel contact lens over 7 days of daily wear.
Participants will attend a Screening visit, a Dispense visit, and a Week 1 Follow-up/exit visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LID021201 | Experimental | LID021201 contact lenses worn in both eyes for 7 days. Lenses will be removed nightly for cleaning and disinfection with OPTI-FREE multipurpose solution. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LID021201 contact lenses | Device | Investigational silicone hydrogel sphere contact lenses for frequent replacement daily wear |
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| Measure | Description | Time Frame |
|---|---|---|
| Front Surface Wettability, by Category | Front surface wettability (i.e., assessment of the disruption of the front surface wettability of the contact lens) was assessed by the investigator for each eye individually. Front surface wettability was collected on a 5-point scale, where where Grade 0 = a smooth uniformly reflecting surface, Grade 1 = a coarse hazy surface which seems resolved momentarily with each blink and becomes exacerbated with staring, Grade 2 = one stable dry (non-wetting) area of some magnitude, Grade 3 = more than one stable dry (non-wetting) area of some magnitude, and Grade 4 = non-wettable lens surface. No formal hypothesis was predefined for the primary endpoint. No inferential testing was performed. | Dispense; Week 1 Follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sr. Clinical Trial Lead, CDMA Vision Care | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigator 6565 | Maitland | Florida | 32751 | United States | ||
| Alcon Investigator 6353 |
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This reporting group includes all subjects/eyes exposed to any study lenses evaluated in this study, except for the lenses used with the purpose of power optimization (Safety Analysis Set).
Subjects were recruited at 3 investigative sites located in the United States.
| ID | Title | Description |
|---|---|---|
| FG000 | LID021201 | LID021201 contact lenses worn in both eyes for 7 days. Lenses were removed nightly for cleaning and disinfection with OPTI-FREE multipurpose solution. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Dec 11, 2020 | Feb 10, 2022 |
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Lens will be provided with investigational product labeling
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| OPTI-FREE multipurpose solution | Device | Solution for cleaning, disinfecting, and reconditioning silicone hydrogel contact lenses |
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| Memphis |
| Tennessee |
| 38111 |
| United States |
| Alcon Investigator 8028 | Wichita Falls | Texas | 76308 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set
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| ID | Title | Description |
|---|---|---|
| BG000 | LID021201 | LID021201 contact lenses worn in both eyes for 7 days. Lenses were removed nightly for cleaning and disinfection with OPTI-FREE multipurpose solution. |
| 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 |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Number | 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 | Front Surface Wettability, by Category | Front surface wettability (i.e., assessment of the disruption of the front surface wettability of the contact lens) was assessed by the investigator for each eye individually. Front surface wettability was collected on a 5-point scale, where where Grade 0 = a smooth uniformly reflecting surface, Grade 1 = a coarse hazy surface which seems resolved momentarily with each blink and becomes exacerbated with staring, Grade 2 = one stable dry (non-wetting) area of some magnitude, Grade 3 = more than one stable dry (non-wetting) area of some magnitude, and Grade 4 = non-wettable lens surface. No formal hypothesis was predefined for the primary endpoint. No inferential testing was performed. | Safety Analysis Set | Posted | Number | eyes | Dispense; Week 1 Follow-up | eyes | eyes |
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Adverse events (AE's) were collected from time of consent to study exit, approximately 1 week.
AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study, except for the lenses used with the purpose of power optimization.
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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 | Pretreatment | Events reported in this group occurred prior to exposure to the study contact lenses | 0 | 39 | 0 | 39 | 0 | 39 |
| EG001 | LID021201 Ocular | Events reported in this group occurred while exposed to the study contact lenses | 0 | 78 | 0 | 78 | 0 | 78 |
| EG002 | LID021201 Nonocular | Events reported in this group occurred while exposed to the study contact lenses | 0 | 39 | 0 | 39 | 0 | 39 |
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Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CDMA Project Lead, Vision Care | Alcon Research, LLC | 1-888-451-3937 | alcon.medinfo@alcon.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 13, 2021 | Feb 10, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Dispense, Grade 1 |
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| Dispense, Grade 2 |
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| Dispense, Grade 3 |
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| Dispense, Grade 4 |
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| Week 1 Follow-up, Grade 0 |
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| Week 1 Follow-up, Grade 1 |
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| Week 1 Follow-up, Grade 2 |
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| Week 1 Follow-up, Grade 3 |
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| Week 1 Follow-up, Grade 4 |
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