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The purpose of this clinical study is to evaluate the on-eye performance of an investigational soft contact lens compared to a commercially available soft contact lens following 1 night of extended wear.
Subjects will be randomized to wear the investigational contact lens in 1 eye and the commercially available contact lens in the other eye. Subjects will be expected to attend 4 scheduled study visits. The lenses will be worn continuously from the time of dispense on Day 1 until lens collection at the Day 2 Follow-up/Exit Visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LID011121 (OD) / Biofinity (OS) | Other | LID011121 contact lens worn in the right eye, with comfilcon A contact lens worn in the left eye, as randomized, for one night of extended (overnight) wear. |
|
| Biofinity (OD) / LID011121 (OS) | Other | Comfilcon A contact lens worn in the right eye, with LID011121 contact lens worn in the left eye, as randomized, for one night of extended (overnight) wear. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LID011121 contact lens | Device | Investigational silicone hydrogel contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity (VA) With Study Lenses, Collected by Eye | 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 a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned. | Day 1 Dispense; Day 1 Follow-up Prior to Sleeping; Day 2 Follow-up Upon Eye Opening; Day 2 Follow-up Approximately 1 Hour after Awakening/Exit |
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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 Investigative Site | Johns Creek | Georgia | 30097 | United States |
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Of the 12 subjects enrolled, 1 was exited from the study prior to randomization as a screen failure. This reporting group includes all randomized subjects (11).
Subjects were recruited from 1 investigative site located in the United States.
| ID | Title | Description |
|---|---|---|
| FG000 | LID011121 (OD) / Biofinity (OS) | LID011121 contact lens worn in the right eye, with comfilcon A contact lens worn in the left eye, as randomized, for one night of extended (overnight) wear |
| FG001 | Biofinity (OD) / LID011121 (OS) | Comfilcon A contact lens worn in the right eye, with LID011121 contact lens worn in the left eye, as randomized, for one night of extended (overnight) wear |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety Analysis Set: All eyes exposed to a study lens evaluated in this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | LID011121 (OD) / Biofinity (OS) | LID011121 contact lens in the right eye, with comfilcon A contact lens in the left eye, as randomized, for one night of extended (overnight) wear |
| BG001 | Biofinity (OD) / LID011121 (OS) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Visual Acuity (VA) With Study Lenses, Collected by Eye | 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 a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned. | Safety Analysis Set | Posted | Mean | Standard Deviation | logMAR | Day 1 Dispense; Day 1 Follow-up Prior to Sleeping; Day 2 Follow-up Upon Eye Opening; Day 2 Follow-up Approximately 1 Hour after Awakening/Exit | eyes | eyes |
|
Adverse events (AE's) were collected from time of consent to study exit, approximately 2 days.
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 eyes exposed to a study lens evaluated in this study.
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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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Punctate keratitis | Eye disorders | MedDRA 21.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CDMA Project Lead, Vision Care | Alcon Research, LLC | 1-888-451-3937 | alcon.medinfo@alcon.com |
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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 7, 2018 | Jul 6, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 9, 2018 | Jul 6, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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In this contralateral study, subjects will be randomized to wear the investigational lens in 1 eye and the control lens in the other eye.
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| Comfilcon A contact lens | Device | Commercially available silicone hydrogel contact lens |
|
|
Comfilcon A contact lens in the right eye, with LID011121 contact lens in the left eye, as randomized, for one night of extended (overnight) wear
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Biofinity |
Comfilcon A contact lens worn in the right eye or left eye, as randomized, for one night of extended (overnight) wear |
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | LID011121 - Ocular | Events reported in this group occurred while exposed to LID011121 contact lenses | 0 | 11 | 0 | 11 | 0 | 11 |
| EG002 | Biofinity - Ocular | Events reported in this group occurred while exposed to comfilcon A contact lenses | 0 | 11 | 0 | 11 | 2 | 11 |
| EG003 | Nonocular/Systemic | Events reported in this group occurred during exposure to the study contact lenses | 0 | 11 | 0 | 11 | 0 | 11 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.