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The purpose of this trial was to compare the performance of an investigational daily disposable contact lens to a commercially available daily disposable contact lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delefilcon A / etafilcon A | Other | Delefilcon A contact lenses worn first, with etafilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each. |
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| Etafilcon A / delefilcon A | Other | Etafilcon A contact lenses worn first, with delefilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delefilcon A contact lens | Device | Investigational, silicone hydrogel, single vision, soft contact lens for daily disposable wear |
|
| Measure | Description | Time Frame |
|---|---|---|
| Corrected Distance Monocular Visual Measurement Reported as Visual Acuity (VA) | As tested for each eye individually while wearing study lenses. VA was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. Positive logMAR values indicated poorer vision, and negative values denoted better visual acuity. | 1 week of wear, replacing lenses daily |
| Overall Comfort | As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. | 1 week of wear, replacing lenses daily |
| Overall Vision Quality | As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision quality was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. | 1 week of wear, replacing lenses daily |
| Overall Handling | As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being difficult and 10 being easy. | 1 week of wear, replacing lenses daily |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Lens Fit | As assessed for each eye individually by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit is reported on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight. | 1 week of wear, replacing lenses daily |
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Inclusion Criteria:
Exclusion Criteria:
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Participants were recruited from 4 US private practices.
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| ID | Title | Description |
|---|---|---|
| FG000 | Delefilcon A / Etafilcon A | Delefilcon A contact lenses worn first, with etafilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each. |
| FG001 | Etafilcon A / Delefilcon A | Etafilcon A contact lenses worn first, with delefilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1, One Week |
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| Period 2, One Week |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | All enrolled participants |
| 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 | Corrected Distance Monocular Visual Measurement Reported as Visual Acuity (VA) | As tested for each eye individually while wearing study lenses. VA was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. Positive logMAR values indicated poorer vision, and negative values denoted better visual acuity. | All enrolled and dispensed participants. | Posted | Mean | Standard Deviation | logMAR | 1 week of wear, replacing lenses daily | eyes | Participants |
|
Adverse events were collected for the duration of the trial: 1 month.
The safely population included all enrolled and exposed 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 | Delefilcon A | Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joachim Nick, Dipl. Ing. (FH) | Alcon Research | +49 6022 240 520 | joachim.nick@cibavision.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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|
| Etafilcon A contact lens | Device | Commercially marketed, HEMA-based, single vision, soft contact lens for daily disposable wear |
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| NOT COMPLETED |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Etafilcon A |
Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week. |
|
|
| Primary | Overall Comfort | As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. | All enrolled and dispensed participants. | Posted | Mean | Standard Deviation | Units on a scale | 1 week of wear, replacing lenses daily |
|
|
|
| Primary | Overall Vision Quality | As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision quality was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. | All enrolled and dispensed participants. | Posted | Mean | Standard Deviation | Units on a scale | 1 week of wear, replacing lenses daily |
|
|
|
| Primary | Overall Handling | As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being difficult and 10 being easy. | All enrolled and dispensed participants. | Posted | Mean | Standard Deviation | Units on a scale | 1 week of wear, replacing lenses daily |
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|
|
| Secondary | Overall Lens Fit | As assessed for each eye individually by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit is reported on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight. | All enrolled and dispensed participants. | Posted | Mean | Standard Deviation | Units on a scale | 1 week of wear, replacing lenses daily | eyes | Participants |
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|
|
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Etafilcon A | Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week. | 0 | 40 | 0 | 40 |
For a period of 10 years, the clinical investigator must hold all trial-related information and documents confidential and must agree to obtain sponsor's written consent before discussing, presenting, publicizing, or otherwise disclosing any preclinical and/or clinical data or impressions from this trial.