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The purpose of this study is to evaluate the performance of the investigational verofilcon A contact lens compared to the commercially available delefilcon A contact lens, by assessing visual acuity as the primary variable.
Enrolled participants will be randomized (2:1) to receive either verofilcon A (test) contact lenses or delefilcon A (control) contact lenses for wear in both eyes and attend 7 office visits: Baseline, Dispense, 1-week follow-up, 2-week follow-up, 1-month follow-up, 2-month follow-up and 3-month follow-up/Exit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DD T2 | Experimental | Verofilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses will be inserted each day and discarded at the end of the day. |
|
| DT 1 | Active Comparator | Delefilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses will be inserted each day and discarded at the end of the day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| verofilcon A contact lenses | Device | Daily disposable soft contact lenses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | VA was assessed for each eye individually using a Snellen chart at a distance of 4 meters. A 20/20 Snellen acuity is considered normal distance eyesight. No formal hypotheses were formulated; hence no inferential testing was performed. | Dispense, Week 1, Week 2, Month 1, Month 2, Month 3 |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Alcon, a Novartis Division | Alcon, a Novartis Division | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigative Site | San Diego | California | 92123 | United States | ||
| Alcon Investigative Site |
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This reporting group includes all randomized subjects (107).
Subjects were recruited from 6 investigational sites located in the US.
| ID | Title | Description |
|---|---|---|
| FG000 | DD T2 | Verofilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses were inserted each day and discarded at the end of the day. |
| FG001 | DT 1 | Delefilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses were inserted each day and discarded at the end of the day. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This analysis set includes all randomized subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | DD T2 | Verofilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses were inserted each day and discarded at the end of the day. |
| BG001 | DT 1 |
| 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 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | VA was assessed for each eye individually using a Snellen chart at a distance of 4 meters. A 20/20 Snellen acuity is considered normal distance eyesight. No formal hypotheses were formulated; hence no inferential testing was performed. | Completed Analysis Set | Posted | Number | eyes | Dispense, Week 1, Week 2, Month 1, Month 2, Month 3 | eyes | eyes |
|
Dispense through study completion, an average of 15 weeks
An adverse event (AE) was defined as 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 as outlined in the study protocol. Completed Analysis Set. "At Risk" population for ocular AEs is included with unit of "eyes."
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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 | DD T2 Ocular | Eyes exposed to verofilcon A contact lenses | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr Director Project Leadership | Alcon, A Novartis Division | 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 | Aug 24, 2017 | Jan 22, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 22, 2017 | Jan 22, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| delefilcon A contact lenses | Device | Daily disposable soft contact lenses |
|
|
| Longwood |
| Florida |
| 32779 |
| United States |
| Alcon Investigative Site | Maitland | Florida | 32751 | United States |
| Alcon Investigative Site | Bloomington | Illinois | 61701 | United States |
| Alcon Investigative Site | Brentwood | Tennessee | 37027 | United States |
| Alcon Investigative Site | Memphis | Tennessee | 38111 | United States |
Delefilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses will be inserted each day and discarded at the end of the day.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
Delefilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses will be inserted each day and discarded at the end of the day.
|
|
| 138 |
| 0 |
| 138 |
| 0 |
| 138 |
| EG001 | DD T2 Non-ocular | Subjects exposed to verofilcon A contact lenses | 0 | 69 | 0 | 69 | 0 | 69 |
| EG002 | DT 1 Ocular | Eyes exposed to delefilcon A contact lenses | 0 | 72 | 0 | 72 | 0 | 72 |
| EG003 | DT 1 Non-ocular | Subjects exposed to delefilcon A contact lenses | 0 | 36 | 0 | 36 | 0 | 36 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.