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The purpose of this clinical study is to assess the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in a daily wear modality with frequent replacement.
Subjects will attend 4 office visits: Screening/Baseline/Dispense; Week 1 Follow-up; Month 1 Follow-up; and Month 3 Follow-up/Exit. The total expected duration of participation for each subject is approximately 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LID015385 | Experimental | LID015385 contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE will be used for nightly cleaning and disinfection. |
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| Biofinity | Active Comparator | Comfilcon A contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE will be used for nightly cleaning and disinfection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LID015385 contact lenses | Device | Investigational soft contact lenses |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) in Each Eye (CLL949-C018 + CLL949-C009) | Visual acuity (VA) was assessed for each eye individually with study lenses in place using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. | Week 1 Follow-Up |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Achieving CLCDVA 20/20 or Better in Each Eye (CLL949-C018 + CLL949-C009) | Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen, with 20/20 Snellen visual acuity considered normal distance eyesight. | Week 1 Follow-Up, at least 4 hours after lens insertion |
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Key Inclusion Criteria:
Key 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 8103 | Glendale | Arizona | 85308 | United States | ||
| Alcon Investigator 8101 |
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Of the 249 participants enrolled in this study, 15 were exited from the study as screen failures prior to randomization. This reporting group includes all randomized subjects/eyes (234/468).
This study was conducted at 18 investigative sites located in the United States.
| ID | Title | Description |
|---|---|---|
| FG000 | Biofinity | Comfilcon A contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE was used for nightly cleaning and disinfection. |
| FG001 | LID015385 |
| 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 | May 13, 2020 | Dec 15, 2021 |
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| Comfilcon A contact lenses |
| Device |
Commercially available soft contact lenses |
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| CLEAR CARE | Device | Hydrogen peroxide-based cleaning and disinfecting solution |
|
| Brentwood |
| California |
| 94513 |
| United States |
| Alcon Investigator 8102 | Irvine | California | 92618 | United States |
| Alcon Investigator 8135 | Los Angeles | California | 90012 | United States |
| Alcon Investigator 8108 | Novato | California | 94945 | United States |
| Alcon Investigator 8062 | Oakland | California | 94607 | United States |
| Alcon Investigator 8109 | San Francisco | California | 94127 | United States |
| Alcon Investigator 6565 | Maitland | Florida | 32751 | United States |
| Alcon Investigator 6355 | Orlando | Florida | 32803 | United States |
| Alcon Investigator 8115 | Norcross | Georgia | 30071 | United States |
| Alcon Investigator 6567 | Pittsburg | Kansas | 66762 | United States |
| Alcon Investigator 8063 | Brighton | Massachusetts | 02135 | United States |
| Alcon Investigator 8100 | New York | New York | 10036 | United States |
| Alcon Investigator 4817 | Cleveland | Ohio | 44106 | United States |
| Alcon Investigator 6313 | Powell | Ohio | 43065 | United States |
| Alcon Investigator 6401 | Warwick | Rhode Island | 02888 | United States |
| Alcon Investigator 6353 | Memphis | Tennessee | 38111 | United States |
| Alcon Investigator 8114 | Plano | Texas | 75093 | United States |
LID015385 contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE was used for nightly cleaning and disinfection. |
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| NOT COMPLETED |
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Per Protocol (PP): All randomized subjects exposed to any study lenses evaluated in this study with at least one post-baseline (post-Dispense) contact lens corrected distance visual acuity (CLCDVA) assessment, minus all data/subjects that met any of the pre-defined critical deviation or evaluability criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | Biofinity | Comfilcon A contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE was used for nightly cleaning and disinfection. |
| BG001 | LID015385 | LID015385 contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE was used for nightly cleaning and disinfection. |
| BG002 | 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 | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) in Each Eye (CLL949-C018 + CLL949-C009) | Visual acuity (VA) was assessed for each eye individually with study lenses in place using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. | PP. A predefined subset of data from another similar completed study, CLL949-C009 (NCT03920280), was combined with this study to attain adequate power for the planned hypothesis testing of the primary and secondary outcome measures. The subset of subjects from CLL949-C009 that contributed data were those with Best-Corrected Visual Acuity (BCVA) of 20/20 or better in each eye at the Screening/Baseline/Dispense Visit. | Posted | Least Squares Mean | Standard Error | logMAR | Week 1 Follow-Up | eyes | eyes |
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| Secondary | Percentage of Subjects Achieving CLCDVA 20/20 or Better in Each Eye (CLL949-C018 + CLL949-C009) | Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen, with 20/20 Snellen visual acuity considered normal distance eyesight. | PP. A predefined subset of data from another similar completed study, CLL949-C009 (NCT03920280), was combined with this study to attain adequate power for the planned hypothesis testing of the primary and secondary outcome measures. The subset of subjects from CLL949-C009 that contributed data were those with Best-Corrected Visual Acuity (BCVA) of 20/20 or better in each eye at the Screening/Baseline/Dispense Visit. | Posted | Number | percentage of subjects | Week 1 Follow-Up, at least 4 hours after lens insertion |
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Adverse events (AE's) were collected from time of consent to study exit, approximately 3 months.
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. The safety analysis set includes all subjects/eyes exposed to any study lenses evaluated in this study. For treatment-emergent safety analyses, subjects/eyes were categorized under the actual study lenses exposed in the corresponding lens sequence.
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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 | 234 | 0 | 234 | 0 | 234 |
| EG001 | Biofinity - Ocular | Events reported in this group occurred while exposed to comfilcon A contact lenses | 0 | 156 | 0 | 156 | 0 | 156 |
| EG002 | Biofinity - Nonocular | Events reported in this group occurred while exposed to comfilcon A contact lenses | 0 | 78 | 0 | 78 | 0 | 78 |
| EG003 | LID015385 - Ocular | Events reported in this group occurred while exposed to LID015385 contact lenses | 0 | 312 | 0 | 312 | 0 | 312 |
| EG004 | LID015385 - Nonocular | Events reported in this group occurred while exposed to LID015385 contact lenses | 0 | 156 | 0 | 156 | 0 | 156 |
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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 5, 2021 | Dec 15, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D009216 | Myopia |
| D006956 | Hyperopia |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Black or African American |
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| Chinese |
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| Japanese |
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| Korean |
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| Other Asian |
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| Other |
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| Units | Counts |
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| Participants |
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