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The purpose of this 4-week dispensing trial is to evaluate and compare an investigational soft contact lens worn on a daily disposable basis with three other soft contact lenses also worn on a daily disposable basis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delefilcon A | Experimental | Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks. |
|
| Lotrafilcon B | Active Comparator | Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks. |
|
| Nelfilcon A | Active Comparator | Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks. |
|
| Narafilcon A | Active Comparator | Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delefilcon A contact lens | Device | Investigational silicone hydrogel, single vision contact lens for daily wear, daily disposable use |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Comfort | Overall comfort was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent. | 4 weeks |
| Vision Quality During the Day | Vision quality during the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Vision quality during the day was measured on a 10-point scale, with 1 being poor and 10 being excellent. | 4 weeks |
| Overall Handling | Overall handling was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall handling was measured on a 10-point scale, with 1 being poor and 10 being excellent. | 4 weeks |
| Dryness Throughout the Day | Dryness throughout the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Dryness throughout the day was measured on a 10-point scale, with 1 being very dry and 10 being not dry. | 4 weeks |
| Average Daily Wear Time | Average daily wear time (hours) was reported by the participant as a single, retrospective evaluation of 4 weeks of wear. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Lens Fit | Lens fit was assessed by the investigator for each eye using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded on a 5-point scale, with 2=unacceptable loose, 1=acceptable loose, 0=optimal, -1=acceptable tight, and -2=unacceptable tight. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIBA VISION Research Clinic | Duluth | Georgia | 30097 | United States | ||
| CIBA VISION Research Clinic |
This reporting group includes all enrolled and dispensed participants (129). One US participant was enrolled, but not dispensed.
Participants were recruited and enrolled from 1 US study center and 1 German study center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Delefilcon A | Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks. |
| FG001 | Lotrafilcon B | Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks. |
| FG002 | Nelfilcon A | Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks. |
| FG003 | Narafilcon A | Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Delefilcon A | Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks. |
| BG001 | Lotrafilcon B | Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | All enrolled and dispensed participants |
| 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 | Overall Comfort | Overall comfort was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent. | Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses. | Posted | Mean | Standard Deviation | Units on a scale | 4 weeks |
|
Adverse events were collected for the duration of the trial: 15-NOV-2010 to 20-DEC-2010.
The safety population included all enrolled and exposed participants: 129.
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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 in both eyes on a daily wear, daily disposable basis for four weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Contact Lens-Related Discomfort | Eye disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Alcon Clinical, Atlanta | Alcon Research | 1-800-241-7629 |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Lotrafilcon B contact lens (O2 OPTIX, AIR OPTIX) | Device | Commercially marketed silicone hydrogel, single vision contact lens for daily wear, daily disposable use |
|
|
| Nelfilcon A contact lens (DAILIES AquaComfort Plus) | Device | Commercially marketed hydrogel, single vision contact lens for daily wear, daily disposable use |
|
|
| Narafilcon A contact lens (1-DAY ACUVUE TRUEYE) | Device | Commercially marketed (Europe) silicone hydrogel, single vision contact lens for daily wear, daily disposable use |
|
|
| Corrected Visual Acuity |
Corrected visual acuity was tested for each eye while the participant read distant charts in normal lighting. Corrected visual acuity was measured with a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity. |
| 4 weeks |
| Overall Satisfaction | Overall satisfaction was recorded on a 5-point Likert scale as a single, retrospective evaluation of 4 weeks of wear. The following scale was used: 2=very satisfied, 1=somewhat satisfied, 0=neither, -1=somewhat dissatisfied, and -2=very dissatisfied. | 4 weeks |
| Großwallstadt |
| 63868 |
| Germany |
| Difficult removal handling |
|
| Symptoms and problems |
|
| Lost to Follow-up |
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| Biomicroscopy |
|
| Discomfort |
|
| BG002 | Nelfilcon A | Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks. |
| BG003 | Narafilcon A | Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks. |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | Nelfilcon A | Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks. |
| OG003 | Narafilcon A | Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks. |
|
|
| Primary | Vision Quality During the Day | Vision quality during the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Vision quality during the day was measured on a 10-point scale, with 1 being poor and 10 being excellent. | Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses. | Posted | Mean | Standard Deviation | Units on a scale | 4 weeks |
|
|
|
| Primary | Overall Handling | Overall handling was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall handling was measured on a 10-point scale, with 1 being poor and 10 being excellent. | Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses. | Posted | Mean | Standard Deviation | Units on a scale | 4 weeks |
|
|
|
| Primary | Dryness Throughout the Day | Dryness throughout the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Dryness throughout the day was measured on a 10-point scale, with 1 being very dry and 10 being not dry. | Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses. | Posted | Mean | Standard Deviation | Units on a scale | 4 weeks |
|
|
|
| Primary | Average Daily Wear Time | Average daily wear time (hours) was reported by the participant as a single, retrospective evaluation of 4 weeks of wear. | Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses. | Posted | Mean | Standard Deviation | Hours | 4 weeks |
|
|
|
| Secondary | Lens Fit | Lens fit was assessed by the investigator for each eye using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded on a 5-point scale, with 2=unacceptable loose, 1=acceptable loose, 0=optimal, -1=acceptable tight, and -2=unacceptable tight. | Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses. | Posted | Mean | Standard Deviation | Units on a scale | 4 weeks | Eyes | Participants |
|
|
|
| Secondary | Corrected Visual Acuity | Corrected visual acuity was tested for each eye while the participant read distant charts in normal lighting. Corrected visual acuity was measured with a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity. | Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses. | Posted | Mean | Standard Deviation | logMAR | 4 weeks | Eyes | Participants |
|
|
|
| Secondary | Overall Satisfaction | Overall satisfaction was recorded on a 5-point Likert scale as a single, retrospective evaluation of 4 weeks of wear. The following scale was used: 2=very satisfied, 1=somewhat satisfied, 0=neither, -1=somewhat dissatisfied, and -2=very dissatisfied. | Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses. | Posted | Mean | Standard Deviation | Units on a scale | 4 weeks |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Lotrafilcon B | Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks. | 0 | 29 | 5 | 29 |
| EG002 | Nelfilcon A | Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks. | 0 | 30 | 2 | 30 |
| EG003 | Narafilcon A | Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks. | 0 | 30 | 2 | 30 |
| Contact Lens-Related Dryness | Eye disorders |
|
| Contact Lens-Related Unacceptable Subjective Vision | Eye disorders |
|
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| Eyes |
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| Eyes |
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