Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this crossover study was to evaluate the end-of-day comfort of two commercially available, daily disposable, silicone hydrogel contact lenses.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAILIES TOTAL1, then TRUEYE | Other | Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks. |
|
| TRUEYE, then DAILIES TOTAL1 | Other | Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delefilcon A contact lenses | Device | CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two |
| Measure | Description | Time Frame |
|---|---|---|
| End-of-day Comfort | End-of-day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective measurement of two weeks of wear. Participants were asked, "Please rate the study lenses you have been wearing the in the following area: End-of-day comfort" and recorded their response on a continuous 1-10 Likert scale (1=poor and 10=excellent). | Week 2 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Camille Girault | Alcon Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Call Center for Trial Locations | Fort Worth | Texas | 76134 | United States |
Of the 123 participants enrolled, two were excluded prior to randomization. This reporting group includes all participants enrolled and exposed to Test Article (121).
Participants were recruited from two study centers in Finland, three study centers in German, and three study centers in the UK.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | DAILIES TOTAL1, Then TRUEYE | Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks. |
| FG001 | TRUEYE, Then DAILIES TOTAL1 | Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Two Weeks of Wear |
|
| |||||||||||||||||||||
| Second Two Weeks of Wear |
|
All participants enrolled and exposed to Test Article
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | OVERALL | Delefilcon A contact lenses and narafilcon A contact lenses worn in randomized order. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks. |
| 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 | End-of-day Comfort | End-of-day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective measurement of two weeks of wear. Participants were asked, "Please rate the study lenses you have been wearing the in the following area: End-of-day comfort" and recorded their response on a continuous 1-10 Likert scale (1=poor and 10=excellent). | This reporting group includes all participants who finished the study, minus any major protocol deviations as determined by masked review. | Posted | Mean | Standard Deviation | Units on a scale | Week 2 |
|
Adverse events were collected for the duration of the study. The safety population includes all participants enrolled and exposed to Test Article.
An adverse event was defined as an event that caused, or had the potential to cause, unexpected or unwanted effects involving the safety of device users (including patients) or other persons.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DAILIES TOTAL1 | Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jami Kern, PhD | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
Not provided
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Narafilcon A contact lenses | Device | CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two |
|
|
| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks |
|
|
| 0 |
| 119 |
| 0 |
| 119 |
| EG001 | TRUEYE | Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks | 0 | 121 | 0 | 121 |
Study data should not be disclosed to any third party for a period of three years after the termination of the study without prior written consent.