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The purpose of this clinical trial is to evaluate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in an extended wear modality.
Subjects will be expected to attend 9 office visits. The total expected duration of participation for each subject is approximately 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LID015385 | Experimental | LID015385 soft contact lenses worn in both eyes for up to 6 nights/7 days continuously (awake and asleep). Must sleep 1 night per week without lenses. Lenses will be replaced as specified in the study protocol. |
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| Biofinity | Active Comparator | Comfilcon A soft contact lenses worn in both eyes for up to 6 nights/7 days continuously (awake and asleep). Must sleep 1 night per week without lenses. Lenses will be replaced as specified in the study protocol. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LID015385 soft contact lenses | Device | Investigational silicone hydrogel contact lenses for up to 6 nights/7 days of continuous wear |
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| 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 was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed. | Day 1 Dispense; Hour 24 Follow-Up; Week 1 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up; Month 6 Follow-up; Month 9 Follow-up, Month 12 Follow-up |
| 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 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 was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed. | Day 1 Dispense; Hour 24 Follow-Up; Week 1 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up; Month 6 Follow-up; Month 9 Follow-up |
| Proportion of Ocular Serious and Significant Non-serious Adverse Device Effects (ADEs) | Calculated as the total number of eyes reporting at least one treatment-emergent, ocular, serious ADE or treatment-emergent, ocular, significant, non-serious ADE, divided by the total number of eyes enrolled and dispensed. An ADE was defined as any adverse event related to the use of the investigational medical device (LID015385) or control product (Biofinity). | Up to Month 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alcon Study Director | Alcon Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Family EyeCare Center | Campbell | California | 95008 | United States | ||
| Winston Eye Care |
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Of the 675 enrolled, 30 participants were exited from the study as screen failures prior to randomization. This reporting group includes all enrolled and dispensed participants (645).
The study population consisted of a Primary cohort, including subjects of any race/ethnic background at 35 Primary cohort sites, and a Supplemental cohort, including subjects of Chinese race only at 7 Supplemental cohort sites.
| ID | Title | Description |
|---|---|---|
| FG000 | Biofinity | Comfilcon A soft contact lenses worn in both eyes for up to 6 nights/7 days continuously (awake and asleep). Must have slept 1 night per week without lenses. Lenses were replaced as specified in the study protocol. |
| 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 | Jan 16, 2020 | Feb 10, 2023 |
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| Comfilcon A soft contact lenses | Device | Silicone hydrogel contact lenses for up to 6 nights/7 days of continuous wear |
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| Fullerton |
| California |
| 92835 |
| United States |
| Kurata Eye Care Center | Los Angeles | California | 90012 | United States |
| East West Eye Institute | Los Angeles | California | 90013 | United States |
| Dr.Elsa Pao, O.D | Oakland | California | 94607 | United States |
| Gordon Schanzlin New Vision Institute | San Diego | California | 92122 | United States |
| Complete Family Vision Care | San Diego | California | 92123 | United States |
| Westview Optometry | San Diego | California | 92129 | United States |
| OMEGA Vision Center PA, DBA Sabal Eye Care | Longwood | Florida | 32779 | United States |
| Kindred Optics at Maitland Vision Center | Maitland | Florida | 32751 | United States |
| Mid Florida Eye Center, PA | Mt. Dora | Florida | 32757 | United States |
| Eola Eyes | Orlando | Florida | 32803 | United States |
| Vision Health Institute | Orlando | Florida | 32803 | United States |
| Visual Performance Center Research & Development | Pensacola | Florida | 32503 | United States |
| Golden Vision | Sarasota | Florida | 34237 | United States |
| Advanced Eyecare Specialists | West Palm Beach | Florida | 33405 | United States |
| VisionPoint Eye Center | Bloomington | Illinois | 61704 | United States |
| Franklin Park Eye Center, PC | Franklin Park | Illinois | 60131 | United States |
| Kannarr Eye Care, LLC | Pittsburg | Kansas | 66762 | United States |
| Optimum Vision Care | Brighton | Massachusetts | 02135 | United States |
| Fraser Eye Care Center | Fraser | Michigan | 48026 | United States |
| Dr. Schwartz Optometrist and Associates | Sterling Heights | Michigan | 48312 | United States |
| Complete Eye Care of Medina | Medina | Minnesota | 55340 | United States |
| Fischer Laser Eye Center, LLC | Willmar | Minnesota | 56201 | United States |
| Tekwnai Vision Center, Inc | St Louis | Missouri | 63128 | United States |
| Alterman, Modi & Wolter | Poughkeepsie | New York | 12603 | United States |
| Rochester Ophthalmological Group, PC | Rochester | New York | 14618 | United States |
| Asheville Eye Associates, PLLC | Asheville | North Carolina | 28803 | United States |
| ProCare Vision Centers, Inc. | Granville | Ohio | 43023 | United States |
| Midwest Vision Care | Piqua | Ohio | 45356 | United States |
| EyeCare Professionals, Inc. DBA Insight Research Clinic, LLC | Powell | Ohio | 43065 | United States |
| Wyomissing Optometric Center | Wyomissing | Pennsylvania | 19610 | United States |
| West Bay Eye Associates | Warwick | Rhode Island | 02888 | United States |
| North Spartanburg Eye Center | Boiling Springs | South Carolina | 29316 | United States |
| Primary Eyecare Group, PC | Brentwood | Tennessee | 37027 | United States |
| Optometry Group, PLLC | Memphis | Tennessee | 38111 | United States |
| Total Eye Care, PA | Memphis | Tennessee | 38119 | United States |
| Advancing Vision Research, LLC | Smyrna | Tennessee | 37167 | United States |
| Beaumont Family Eye Care | Beaumont | Texas | 77706 | United States |
| Vision One Eyecare | Katy | Texas | 77450 | United States |
| Dawn M Rakich, OD | San Antonio | Texas | 78213 | United States |
| Clarke EyeCare Center | Wichita Falls | Texas | 76308 | United States |
LID015385 soft contact lenses worn in both eyes for up to 6 nights/7 days continuously (awake and asleep). Must have slept 1 night per week without lenses. Lenses were replaced as specified in the study protocol. |
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| Primary Cohort Started |
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| Primary Cohort Completed |
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| Primary Cohort Discontinued |
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| COMPLETED | Includes Primary Cohort and Supplemental Cohort |
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| NOT COMPLETED |
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This analysis population includes enrolled subjects who were also dispensed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Biofinity | Comfilcon A soft contact lenses worn in both eyes for up to 6 nights/7 days continuously (awake and asleep). Must have slept 1 night per week without lenses. Lenses were replaced as specified in the study protocol. |
| BG001 | LID015385 | LID015385 soft contact lenses worn in both eyes for up to 6 nights/7 days continuously (awake and asleep). Must have slept 1 night per week without lenses. Lenses were replaced as specified in the study protocol. |
| 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 was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed. | This analysis population includes all enrolled dispensed subjects/eyes completing the study, with data at scheduled study visit. This outcome measure was pre-specified for the Primary Cohort. | Posted | Mean | Standard Deviation | logMAR | Day 1 Dispense; Hour 24 Follow-Up; Week 1 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up; Month 6 Follow-up; Month 9 Follow-up, Month 12 Follow-up | 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 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 was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed. | This analysis population includes all enrolled and dispensed subjects/eyes not completing the study, with data at scheduled study visit. This outcome measure was pre-specified for the Primary Cohort. | Posted | Mean | Standard Deviation | logMAR | Day 1 Dispense; Hour 24 Follow-Up; Week 1 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up; Month 6 Follow-up; Month 9 Follow-up | eyes | eyes |
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| Primary | Proportion of Ocular Serious and Significant Non-serious Adverse Device Effects (ADEs) | Calculated as the total number of eyes reporting at least one treatment-emergent, ocular, serious ADE or treatment-emergent, ocular, significant, non-serious ADE, divided by the total number of eyes enrolled and dispensed. An ADE was defined as any adverse event related to the use of the investigational medical device (LID015385) or control product (Biofinity). | This analysis population includes all enrolled subjects who were also dispensed. This outcome measure was pre-specified for the Primary Cohort. | Posted | Number | proportion of eyes | Up to Month 12 | eyes | eyes |
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Adverse events (AE's) were collected from time of consent to study exit, approximately 12 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 dispense of the study contact lenses | 0 | 645 | 0 | 645 | 0 | 645 |
| EG001 | Control Ocular | Events reported in this group occurred following dispense of the comfilcon A contact lenses | 0 | 646 | 4 | 646 | 0 | 646 |
| EG002 | Control Nonocular | Events reported in this group occurred following dispense of the comfilcon A contact lenses | 0 | 323 | 2 | 323 | 0 | 323 |
| EG003 | Test Ocular | Events reported in this group occurred following dispense of the LID015385 contact lenses | 0 | 644 | 0 | 644 | 0 | 644 |
| EG004 | Test Nonocular | Events reported in this group occurred following dispense of the LID015385 contact lenses | 0 | 322 | 3 | 322 | 0 | 322 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ulcerative keratitis | Eye disorders | MedDRA 23.0 | Systematic Assessment |
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| Hypopyon | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 23.0 | Systematic Assessment |
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| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA 23.0 | Systematic Assessment |
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| Intervertebral disc operation | Surgical and medical procedures | MedDRA 23.0 | 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 | |
|---|---|---|---|---|
| Expert 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 | Mar 25, 2021 | Feb 10, 2023 | SAP_001.pdf |
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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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