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The purpose of this study is to evaluate the performance of an investigational daily disposable contact lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| delefilcon A | Experimental | Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months. |
|
| narafilcon B | Active Comparator | Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| delefilcon A contact lens | Device | Investigational silicone hydrogel, single vision soft contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Corrected Distance Monocular Visual Measurement in Normal Illumination Reported as Visual Acuity | Each eye tested individually while reading a chart distant to the participant in normal lighting. Visual acuity was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. Visual acuity is reported as the number of eyes achieving 20/20 Snellen acuity or better. | 3 months of wear, lenses replaced daily |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Vision | As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall vision was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. | 3 months of wear, lenses replaced daily |
| Overall Comfort |
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Inclusion Criteria:
Exclusion Criteria:
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This reporting group includes all enrolled participants.
Participants were recruited and enrolled from six (6) US study centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Delefilcon A | Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months. |
| FG001 | Narafilcon B | Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Delefilcon A | Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months. |
| BG001 | Narafilcon B | Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months. |
| 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 | Corrected Distance Monocular Visual Measurement in Normal Illumination Reported as Visual Acuity | Each eye tested individually while reading a chart distant to the participant in normal lighting. Visual acuity was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. Visual acuity is reported as the number of eyes achieving 20/20 Snellen acuity or better. | Per protocol. | Posted | Number | eyes | 3 months of wear, lenses replaced daily | eyes | Participants |
|
Adverse events were collected for the duration of the study: 19-JAN-2011 to 20-MAY-2011.
This reporting group includes 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 | Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sterile infiltrate with secondary iritis | Eye disorders | One eye. Resolved. Resumed wearing study lenses and completed the study. |
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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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| narafilcon B contact lens | Device | Commercially marketed silicone hydrogel, single vision soft contact lens |
|
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. |
| 3 months of wear, lenses replaced daily |
| Overall Handling | As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. | 3 months of wear, lenses replaced daily |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
|
|
| Secondary | Overall Vision | As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall vision was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. | Per protocol. | Posted | Mean | Standard Deviation | Units on a scale | 3 months of wear, lenses replaced daily |
|
|
|
| Secondary | Overall Comfort | As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. | Per protocol. | Posted | Mean | Standard Deviation | Units on a scale | 3 months of wear, lenses replaced daily |
|
|
|
| Secondary | Overall Handling | As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. | Per protocol. | Posted | Mean | Standard Deviation | Units on a scale | 3 months of wear, lenses replaced daily |
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | Narafilcon B | Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months. | 1 | 30 | 0 | 30 |
|
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.