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The purpose of this study was to evaluate the performance of a novel silicone hydrogel contact lens, DAILIES TOTAL1® (DT1) compared to the standard hydrogel material in 1-DAY ACUVUE® MOIST® (1DAVM) contact lens in contact lens wearers identified as having contact lens-related dryness symptoms.
Three study visits occurred over the course of 28 ± 3 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DT1 | Experimental | Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks |
|
| 1DAVM | Active Comparator | Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delefilcon A contact lenses | Device | Silicone hydrogel contact lenses for daily wear, daily disposable use |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ | Contact lens symptoms were evaluated using the Contact Lens and Dry Eye Questionnaire (CLDEQ). The participant indicated the frequency with which 9 common contact lens-related ocular surface dryness symptoms were experienced over the previous week. Each symptom was rated on a 5-point scale (1=never, 5=constantly). Both eyes contributed to the mean. A more negative change number indicates a greater perceived improvement, namely, lessening of the symptom. | Day 0, Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jami Kern, Ph.D. | Alcon Research | Study Director |
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This reporting group includes all enrolled and randomized participants.
Participants were recruited from 1 US study center.
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| ID | Title | Description |
|---|---|---|
| FG000 | DAILIES TOTAL1 | Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks |
| FG001 | 1DAVM | Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This reporting group includes all enrolled and randomized participants who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | DAILIES TOTAL1 | Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks |
| BG001 | 1DAVM | Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 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 | Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ | Contact lens symptoms were evaluated using the Contact Lens and Dry Eye Questionnaire (CLDEQ). The participant indicated the frequency with which 9 common contact lens-related ocular surface dryness symptoms were experienced over the previous week. Each symptom was rated on a 5-point scale (1=never, 5=constantly). Both eyes contributed to the mean. A more negative change number indicates a greater perceived improvement, namely, lessening of the symptom. | All enrolled and randomized participants who completed the study. | Posted | Mean | Standard Deviation | Units on a scale | Day 0, Week 4 |
|
Adverse events were collected for the duration of the study (4 months).
This reporting group includes all enrolled participants who were exposed to the test product.
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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 TOTAL1 | Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Contact lens fell out | Eye disorders |
The study was not powered to detect differences in individual items.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jami Kern, PhD | Alcon Research, Ltd. | 1-888-452-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D009216 | Myopia |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
| D007766 | Lacrimal Apparatus Diseases |
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| Etafilcon A contact lenses | Device | Hydrogel contact lenses for daily wear, daily disposable use |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 1DAVM | Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks |
|
|
| 0 |
| 30 |
| 7 |
| 30 |
| EG001 | 1DAVM | Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks | 0 | 32 | 8 | 32 |
| Eye irritation | Eye disorders |
|
| Corneal Staining | Eye disorders |
|
| Foreign body sensation | Eye disorders |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.