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The purpose of this clinical study is to demonstrate 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 randomized to wear either the investigational contact lenses or the commercially available contact lenses in both eyes. Subjects will be expected to attend 6 scheduled study visits. Individual participation in the study will be approximately 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LID015385 | Experimental | LID015385 contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses will be removed nightly for cleaning with CLEAR CARE. |
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| Biofinity | Active Comparator | Comfilcon A contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses will be removed nightly for cleaning with CLEAR CARE. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LID015385 contact lenses | Device | Investigational silicone hydrogel contact lenses |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Distance Visual Acuity (VA) With Study Lenses - Completed Eyes | 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 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. No formal hypothesis testing was planned. | Day 1 Dispense; Week 1 Follow-up; Week 2 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up/Exit (at least 4 hours after lens insertion at each follow-up assessment visit) |
| Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes | 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 and converted to the logarithm minimum angle of resolution (logMAR) scale. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No formal hypothesis testing was planned. | Day 1 Dispense; Week 1 Follow-up; Week 2 Follow-up; Month 1 Follow-up; Month 2 Follow-up (at least 4 hours after lens insertion at each follow-up assessment visit) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| CDMA Project Lead, Vision Care | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigator 6565 | Maitland | Florida | 32751 | United States | ||
| Alcon Investigator 6355 |
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Of the 120 subjects enrolled, 1 was exited from the study prior to randomization as a screen failure. This reporting group includes all enrolled and dispensed subjects (119).
Subjects were recruited from 8 investigative sites located in the United States.
| ID | Title | Description |
|---|---|---|
| FG000 | Biofinity | Comfilcon A contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses were removed nightly for cleaning with CLEAR CARE. |
| 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 | Mar 22, 2019 | Oct 12, 2021 |
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| Comfilcon A soft contact lenses |
| Device |
Commercially available silicone hydrogel contact lenses |
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| CLEAR CARE | Device | Hydrogen peroxide-based cleaning and disinfecting system |
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| Orlando |
| Florida |
| 32803 |
| United States |
| Alcon Investigator 6291 | Pensacola | Florida | 32503 | United States |
| Alcon Investigator 3950 | Bloomington | Illinois | 61704 | United States |
| Alcon Investigator 6567 | Pittsburg | Kansas | 66762 | 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 |
LID015385 contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses were removed nightly for cleaning with CLEAR CARE. |
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| NOT COMPLETED |
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This analysis population includes all enrolled and dispensed subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Biofinity | Comfilcon A contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses were removed nightly for cleaning with CLEAR CARE. |
| BG001 | LID015385 | LID015385 contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses were removed nightly for cleaning with CLEAR CARE. |
| 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 (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 | Distance Visual Acuity (VA) With Study Lenses - Completed Eyes | 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 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. No formal hypothesis testing was planned. | This analysis population includes all enrolled and dispensed subjects/eyes that completed the study. | Posted | Mean | Standard Deviation | logMAR | Day 1 Dispense; Week 1 Follow-up; Week 2 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up/Exit (at least 4 hours after lens insertion at each follow-up assessment visit) | eyes | eyes |
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| Primary | Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes | 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 and converted to the logarithm minimum angle of resolution (logMAR) scale. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No formal hypothesis testing was planned. | This analysis population includes all enrolled and dispensed subjects/eyes that discontinued the study early. | Posted | Mean | Standard Deviation | logMAR | Day 1 Dispense; Week 1 Follow-up; Week 2 Follow-up; Month 1 Follow-up; Month 2 Follow-up (at least 4 hours after lens insertion at each follow-up assessment visit) | 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. This analysis population includes all enrolled and dispensed subjects.
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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 | 119 | 0 | 119 | 0 | 119 |
| EG001 | Biofinity - Ocular | Events reported in this group occurred while exposed to the comfilcon A contact lenses | 0 | 82 | 1 | 82 | 0 | 82 |
| EG002 | Biofinity - Nonocular/Systemic | Events reported in this group occurred while exposed to the comfilcon A contact lenses | 0 | 41 | 0 | 41 | 0 | 41 |
| EG003 | LID015385 - Ocular | Events reported in this group occurred while exposed to the LID015385 contact lenses | 0 | 156 | 0 | 156 | 0 | 156 |
| EG004 | LID015385 - Nonocular/Systemic | Events reported in this group occurred while exposed to the LID015385 contact lenses | 0 | 78 | 0 | 78 | 0 | 78 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ulcerative keratitis | Eye disorders | MedDRA 22.0 | Systematic Assessment |
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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 19, 2019 | Oct 12, 2021 | 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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| Asian |
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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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| Week 2 Follow-up |
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| Month 1 Follow-up |
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| Month 2 Follow-up |
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| Month 3 Follow-up/Exit |
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| Units | Counts |
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| Participants |
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| eyes |
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