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The purpose of this trial was to compare the performance of two contact lenses commercially available for people with astigmatism.
This trial compared the performance of two commercialized daily disposable contact lenses in Germany.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nelfilcon A / etafilcon A | Other | Nelfilcon A lenses worn first, with etafilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each. |
|
| etafilcon A / nelfilcon A | Other | Etafilcon A lenses worn first, with nelfilcon A 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 |
|---|---|---|---|---|
| nelfilcon A contact lens | Device | Commercially marketed, nelfilcon A, toric, soft contact lens for daily disposable wear. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Vision | As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent. | 1 week, 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 rated on a 10-point scale, with 1 being poor and 10 being excellent. | 1 week, 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 rated on a 10-point scale, with 1 being difficult and 10 being easy. | 1 week, replacing lenses daily |
| Overall Satisfaction | As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent. | 1 week, replacing lenses daily |
| Measure | Description | Time Frame |
|---|---|---|
| Ease of Selecting Final Lens Power | As interpreted by the investigator at time of lens fitting and recorded on a questionnaire. Ease of selecting final lens power was rated on a 10-point scale, with 1 being difficult and 10 being easy. | Day 0 |
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Inclusion Criteria:
Exclusion Criteria:
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Two participants were enrolled, but not dispensed, due to unacceptable objective vision (1) and biomicroscopy findings (1). Baseline characteristics are presented on all enrolled and dispensed participants: 238.
Participants were recruited and enrolled from 19 German study sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nelfilcon A / Etafilcon A | Nelfilcon A lenses worn first, with etafilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each. |
| FG001 | Etafilcon A / Nelfilcon A | Etafilcon A lenses worn first, with nelfilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period One, 1 Week |
| |||||||||||||
| Period Two, 1 Week |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | All enrolled and dispensed participants. |
| 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 | Overall Vision | As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent. | The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit. | Posted | Mean | Standard Deviation | Units on a scale | 1 week, replacing lenses daily |
|
Adverse events were collected for the duration of the study: 20-May-2011 to 15-AUG-2011.
The safety population included 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 | Nelfilcon A | Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Surgical and medical procedures | Unrelated |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stacie Cummings, O.D. | Alcon Research, Ltd. | 1-800-241-7629 |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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|
| etafilcon A contact lens | Device | Commercially marketed, etafilcon A, toric, soft contact lens for daily disposable wear. |
|
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Etafilcon A 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 rated on a 10-point scale, with 1 being poor and 10 being excellent. | The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit. | Posted | Mean | Standard Deviation | Units on a scale | 1 week, 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 rated on a 10-point scale, with 1 being difficult and 10 being easy. | The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit. | Posted | Mean | Standard Deviation | Units on a scale | 1 week, replacing lenses daily |
|
|
|
| Primary | Overall Satisfaction | As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent. | The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit. | Posted | Mean | Standard Deviation | Units on a scale | 1 week, replacing lenses daily |
|
|
|
| Secondary | Ease of Selecting Final Lens Power | As interpreted by the investigator at time of lens fitting and recorded on a questionnaire. Ease of selecting final lens power was rated on a 10-point scale, with 1 being difficult and 10 being easy. | The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit. | Posted | Mean | Standard Deviation | Units on a scale | Day 0 |
|
|
|
| 2 |
| 234 |
| 0 |
| 234 |
| EG001 | Etafilcon A | Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week. | 0 | 235 | 0 | 235 |
| Foot injury requiring hospitalization | Musculoskeletal and connective tissue disorders | Unrelated |
|
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.