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The purpose of this clinical study is to evaluate 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.
Subjects will be expected to 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 3-4 months in this daily wear clinical study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LID018869 | Experimental | Lehfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses will be worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE will be used for nightly contact lens cleaning and disinfection. |
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| Biofinity | Active Comparator | Comfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses will be worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE will be used for nightly contact lens cleaning and disinfection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lehfilcon A contact lenses | Device | Investigational silicone hydrogel contact lenses |
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| Measure | Description | Time Frame |
|---|---|---|
| Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) at Week 1 Follow-Up | 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 at Week 1 Follow-Up | Visual acuity (VA) was assessed for each eye individually with study lenses in place using a letter chart. VA was collected in Snellen, with 20/20 Snellen visual acuity considered normal distance eyesight. Subjects achieving at least 20/20 Snellen in each eye, left and right, contributed to the analysis. | Week 1 Follow-Up |
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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 Investigative Site | Los Angeles | California | 90012 | United States | ||
| Alcon Investigative Site |
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Of the 158 enrolled, 11 subjects were not dispensed study lenses and were exited from the study as screen failures. This reporting group includes all subjects who were dispensed study lenses (147).
Participants were recruited from 14 sites located in the United States.
| ID | Title | Description |
|---|---|---|
| FG000 | Biofinity | Comfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses were worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE was used for nightly contact lens cleaning and disinfection. |
| FG001 |
| 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 26, 2020 | Feb 3, 2022 |
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| Comfilcon A contact lenses | Device | Commercially available silicone hydrogel contact lenses |
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| CLEAR CARE | Device | Hydrogen peroxide-based contact lens cleaning and disinfecting solution |
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| Novato |
| California |
| 94945 |
| United States |
| Alcon Investigative Site | Oakland | California | 94513 | United States |
| Alcon Investigative Site | Oakland | California | 94607 | United States |
| Alcon Investigative Site | San Francisco | California | 94122 | United States |
| Alcon Investigative Site | Orlando | Florida | 32803 | United States |
| Alcon Investigative Site | West Palm Beach | Florida | 33405 | United States |
| Alcon Investigative Site | Downers Grove | Illinois | 60515 | United States |
| Alcon Investigative Site | Louisville | Kentucky | 40221 | United States |
| Alcon Investigative Site | New York | New York | 10036 | United States |
| Alcon Investigative Site | Cleveland | Ohio | 44106 | United States |
| Alcon Investigative Site | Boiling Springs | South Carolina | 29316 | United States |
| Alcon Investigative Site | Plano | Texas | 75093 | United States |
| Alcon Investigative Site | Wichita Falls | Texas | 76308 | United States |
| LID018869 |
Lehfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses were worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE was used for nightly contact lens 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 silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses were worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE was used for nightly contact lens cleaning and disinfection. |
| BG001 | LID018869 | Lehfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses were worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE was used for nightly contact lens 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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| 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) at Week 1 Follow-Up | 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 subjects (those with BCVA of 20/20 or better in each eye at baseline/dispense) from another similar completed registration study, CLY935-C010 (NCT04178720) was combined with this study to attain adequate power for the planned hypothesis testing of the primary and secondary endpoints. This included 49 subjects from CLY935-C012 and 39 subjects from CLY935-C010 in the Biofinity group and 92 subjects from CLY935-C012 and 78 subjects from CLY935-C010 in the LID018869 group. | 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 at Week 1 Follow-Up | Visual acuity (VA) was assessed for each eye individually with study lenses in place using a letter chart. VA was collected in Snellen, with 20/20 Snellen visual acuity considered normal distance eyesight. Subjects achieving at least 20/20 Snellen in each eye, left and right, contributed to the analysis. | PP: A predefined subset of subjects (those with BCVA of 20/20 or better in each eye at baseline/dispense) from another similar completed registration study, CLY935-C010 (NCT04178720) was combined with this study to attain adequate power for the planned hypothesis testing of the primary and secondary endpoints. This included 49 subjects from CLY935-C012 and 39 subjects from CLY935-C010 in the Biofinity group and 92 subjects from CLY935-C012 and 78 subjects from CLY935-C010 in the LID018869 group. | Posted | Number | percentage of subjects | Week 1 Follow-Up | eyes | eyes |
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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.
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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 | Pre-Treatment | Events reported in this group occurred prior to exposure to the study contact lenses | 0 | 147 | 0 | 147 | 0 | 147 |
| EG001 | Biofinity Ocular | Events reported in this group occurred while exposed to comfilcon A contact lenses | 0 | 100 | 0 | 100 | 0 | 100 |
| EG002 | Biofinity Non-Ocular | Events reported in this group occurred while exposed to comfilcon A contact lenses | 0 | 50 | 0 | 50 | 0 | 50 |
| EG003 | LID018869 Ocular | Events reported in this group occurred while exposed to LID018869 contact lenses | 0 | 194 | 0 | 194 | 0 | 194 |
| EG004 | LID018869 Non-Ocular | Events reported in this group occurred while exposed to LID018869 contact lenses | 0 | 97 | 0 | 97 | 0 | 97 |
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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 | Apr 28, 2021 | Feb 3, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| 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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