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The purpose of this study is to assess the overall clinical performance of a contact lens made with a modified manufacturing process.
The expected duration of subject participation in the study is approximately 4 days with 2 scheduled visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LID220365 (OD) / LID006961 (OS) | Other | LID220365 contact lens worn in the right eye (OD), with LID006961 contact lens worn in the left eye (OS), as randomized, for four days. A fresh pair of lenses will be worn each day. |
|
| LID006961 (OD) / LID220365 (OS) | Other | LID006961 contact lens worn in the right eye (OD), with LID220365 contact lens worn in the left eye (OS), as randomized, for four days. A fresh pair of lenses will be worn each day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LID220365 contact lens | Device | Investigational delefilcon A spherical contact lens made with a modified manufacturing process |
|
| Measure | Description | Time Frame |
|---|---|---|
| Least Squares Mean Distance Visual Acuity (VA) With Study Lenses at Day 4 | VA was assessed for each eye individually at a distance of 4 meters with contact lenses in place using a letter chart. VA was measured in 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. | Day 4 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Lead, Vision Care | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kindred Optics at Maitland Vision | Maitland | Florida | 32751 | United States | ||
| Vision Health Institute |
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Of the 114 enrolled, 1 participant was exited from the study prior to randomization as a screen failure. This reporting group includes all randomized participants (113).
Participants were recruited from 7 investigative sites located in the United States.
| ID | Title | Description |
|---|---|---|
| FG000 | LID220365 (OD) / LID006961 (OS) | LID220365 contact lens worn in the right eye (OD), with LID006961 contact lens worn in the left eye (OS), as randomized, for four days. A fresh pair of lenses was worn each day. |
| FG001 | LID006961 (OD) / LID220365 (OS) | LID006961 contact lens worn in the right eye (OD), with LID220365 contact lens worn in the left eye (OS), as randomized, for four days. A fresh pair of lenses was worn each day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Full Analysis Set: All randomized subjects who are exposed to any study lenses evaluated in this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | LID220365 (OD) / LID006961 (OS) | LID220365 contact lens worn in the right eye (OD), with LID006961 contact lens worn in the left eye (OS), as randomized, for four days. A fresh pair of lenses was worn each day. |
| BG001 | LID006961 (OD) / LID220365 (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 | Least Squares Mean Distance Visual Acuity (VA) With Study Lenses at Day 4 | VA was assessed for each eye individually at a distance of 4 meters with contact lenses in place using a letter chart. VA was measured in 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. | Full Analysis Set | Posted | Least Squares Mean | Standard Error | logMAR | Day 4 | eyes | eyes |
|
Adverse events (AEs) were collected from time of consent to study exit, approximately 4 days.
AEs 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 subjects. This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study. The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.
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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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Clinical 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 | Jan 10, 2023 | Jun 21, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 9, 2023 | Jun 21, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D009216 | Myopia |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| LID006961 contact lens | Device | Commercially available delefilcon A spherical contact lens |
|
|
| Orlando |
| Florida |
| 32803 |
| United States |
| Franklin Park Eye Center PC | Franklin Park | Illinois | 60131 | United States |
| SUNY College of Optometry Clinical Vision Research Center | New York | New York | 10036 | United States |
| Wyomissing Optometric Center | Wyomissing | Pennsylvania | 19610 | United States |
| Optometry Group, PLLC | Memphis | Tennessee | 38111 | United States |
| Clarke Eyecare Center | Wichita Falls | Texas | 76308 | United States |
LID006961 contact lens worn in the right eye (OD), with LID220365 contact lens worn in the left eye (OS), as randomized, for four days. A fresh pair of lenses was worn each day. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
LID006961 contact lens worn in the right eye (OD) or left eye (OS), as randomized, for four days. A fresh pair of lenses was worn each day.
|
|
|
| 0 |
| 113 |
| 0 |
| 113 |
| 0 |
| 113 |
| EG001 | LID220365 Ocular | Events reported in this group occurred while exposed to the LID220365 contact lens. | 0 | 113 | 0 | 113 | 0 | 113 |
| EG002 | LID006961 Ocular | Events reported in this group occurred while exposed to the LID006961 contact lens. | 0 | 113 | 0 | 113 | 0 | 113 |
| EG003 | Overall Non-Ocular | Events reported in this group occurred while exposed to the study contact lenses. | 0 | 113 | 0 | 113 | 0 | 113 |
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