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The purpose of this study was to evaluate the reduction of contact lens-related dryness symptoms when symptomatic weekly/monthly contact lens wearers were switched to DAILIES® AquaComfort Plus® lenses for a two-week period using composite scores on the Contact Lens Dry Eye Questionnaire (CLDEQ).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAILIES® AquaComfort Plus® | Experimental | Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nelfilcon A contact lenses | Device | Commercially marketed hydrogel contact lenses for daily wear, daily disposable use |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Contact Lens-Related Dryness Symptoms at Week 1 and Week 2 | Contact lens symptoms were evaluated using the Contact Lens Dry Eye Questionnaire (CLDEQ). Subjects rated 8 common contact lens-related ocular surface dryness symptoms at Baseline, Week 1, and Week 2 using a 5-point scale (1=never or not at all intense, 5=constantly or very intense). A scoring algorithm was used to calculate a composite score for each visit for all symptoms (-6.5 to 10). A higher composite score would indicate more contact lens related dry eye and a lower score, less contact lens related dry eye. | Baseline, Week 1, Week 2 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jami Kern, MBA, PhD | Alcon Research | Study Director |
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Of the 91 participants enrolled, 3 were exited as screen failures prior to dispensing of the study product. This reporting group includes all enrolled and dispensed participants.
Participants were recruited from 8 study centers located in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | DAILIES® AquaComfort Plus® | Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
This reporting group includes all enrolled and dispensed participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | DAILIES® AquaComfort Plus® | Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Mean Change From Baseline in Contact Lens-Related Dryness Symptoms at Week 1 and Week 2 | Contact lens symptoms were evaluated using the Contact Lens Dry Eye Questionnaire (CLDEQ). Subjects rated 8 common contact lens-related ocular surface dryness symptoms at Baseline, Week 1, and Week 2 using a 5-point scale (1=never or not at all intense, 5=constantly or very intense). A scoring algorithm was used to calculate a composite score for each visit for all symptoms (-6.5 to 10). A higher composite score would indicate more contact lens related dry eye and a lower score, less contact lens related dry eye. | Per Protocol: All enrolled and dispensed participants, minus any major protocol deviators as determined by masked review. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 1, Week 2 |
|
Adverse events were collected for the duration of the study (3 months).
This reporting group includes all enrolled and dispensed participants.
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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 | DAILIES® AquaComfort Plus® | Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jami Kern, MBA, PhD | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D009216 | Myopia |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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| Protocol deviation |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 88 |
| 0 |
| 88 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.