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The purpose of this study is to assess the clinical performance of an investigational, coated silicone hydrogel contact lens over approximately 30 days of daily wear.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LID014341 | Experimental | LID014341 contact lenses worn bilaterally (in both eyes) for 30 days on a daily wear basis |
|
| Biofinity | Active Comparator | Comfilcon A contact lenses worn bilaterally for 30 days on a daily wear basis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LID014341 contact lenses | Device | Investigational monthly replacement silicone hydrogel contact lenses with water gradient coating |
|
| Measure | Description | Time Frame |
|---|---|---|
| Distance Visual Acuity (VA) | VA was tested monocularly (each eye individually) without visual correction under photopic (well-lit) conditions. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. A lower numeric value represents better visual acuity. Both eyes contributed to the analysis. No formal statistical hypothesis testing was planned. | Day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alcon Research | Alcon Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigative Site | Maitland | Florida | 32751 | United States | ||
| Alcon Investigative Site |
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Of the 88 enrolled, 2 subjects exited as screen failures prior to randomization. This reporting group includes all randomized subjects (86).
Subjects were recruited from 4 study centers located in the US.
| ID | Title | Description |
|---|---|---|
| FG000 | LID014341 | LID014341 contact lenses were worn bilaterally (in both eyes) for 30 days on a daily wear basis |
| FG001 | Biofinity | Comfilcon A contact lenses were worn bilaterally for 30 days on a daily wear basis |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
This analysis population included all subjects/eyes exposed to any study lens evaluated in this study (Safety Analysis Set).
| ID | Title | Description |
|---|---|---|
| BG000 | LID014341 | LID014341 contact lenses were worn bilaterally (in both eyes) for 30 days on a daily wear basis |
| BG001 | Biofinity | Comfilcon A contact lenses were worn bilaterally for 30 days on a daily wear basis |
| 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 | Distance Visual Acuity (VA) | VA was tested monocularly (each eye individually) without visual correction under photopic (well-lit) conditions. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. A lower numeric value represents better visual acuity. Both eyes contributed to the analysis. No formal statistical hypothesis testing was planned. | Safety Analysis Set. Overall number of units analyzed is the number of eyes with non-missing response. | Posted | Mean | Standard Deviation | logMAR | Day 30 | Eyes | Eyes |
|
Dispense through study completion, an average of 1 month (30 days)
Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population included all subjects/eyes exposed to any study lens evaluated in this study (Safety Analysis Set), based on treatment-specific exposure.
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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 | LID014341 | LID014341 contact lenses were worn bilaterally (in both eyes) for 30 days on a daily wear basis |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CDMA Project Lead | Alcon Research | 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 | Jun 18, 2018 | Apr 6, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 13, 2018 | Apr 6, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Comfilcon A contact lenses | Device | Silicone hydrogel contact lenses |
|
|
| Johns Creek |
| Georgia |
| 30097 |
| United States |
| Alcon Investigative Site | Bloomington | Illinois | 61701 | United States |
| Alcon Investigative Site | Memphis | Tennessee | 38111 | United States |
| BG002 | Total | Total of all reporting groups |
| Eyes |
|
| years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Biofinity |
Comfilcon A contact lenses were worn bilaterally for 30 days on a daily wear basis |
|
|
| 0 |
| 58 |
| 0 |
| 58 |
| 0 |
| 58 |
| EG001 | Biofinity | Comfilcon A contact lenses were worn bilaterally for 30 days on a daily wear basis | 0 | 28 | 0 | 28 | 0 | 28 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.