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The purpose of this study is to evaluate functional vision associated with rotational stability at blink of DAILIES® AquaComfort Plus® Toric (DACP T) compared to 1-DAY ACUVUE® MOIST® for Astigmatism (1DAM A).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DACP T, Then 1DAM A | Other | Nelfilcon A toric contact lenses worn first, with etafilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days. |
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| 1DAM A, Then DACP T | Other | Etafilcon A toric contact lenses worn first, with nelfilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nelfilcon A toric contact lenses | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| High Contrast Time Controlled Visual Acuity (TCVA) at Day 10 | TCVA test was performed at 4 meters under high illumination (90%) using a Landolt ring test. For each acuity level, a series of single rings with gaps in one of four directions was presented and the percentage of correctly identified rings constituted the score. TCVA was measured in VA units and a higher TCVA value indicates an improvement in visual acuity. Both eyes contributed to the analysis. | Day 10, each product |
| Measure | Description | Time Frame |
|---|---|---|
| Lens Oscillation at Blink at Day 10 | Lens oscillation (rotational stability of the lens on the eye) at blink was video-recorded. Digital images were used to measure the rotational characteristics of the lenses and objectively measure the amplitude of the lens oscillation. A higher value indicates greater lens movement on the eye. This outcome measure was collected at one site only. | Day 10, each product |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Manager, EMEA | Alcon Research | Study Director |
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This reporting group includes all enrolled participants, as treated. Note: 2 participants randomized to DACP T were exited prior to dispense due to unacceptable fit (1) and unavailable lens power (1).
Subjects were recruited from 1 study center located in the US and 1 study center located in the UK.
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| ID | Title | Description |
|---|---|---|
| FG000 | DACP T, Then 1DAM A | Nelfilcon A toric contact lenses worn first, with Etafilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days. |
| FG001 | 1DAM A, Then DACP T | Etafilcon A toric contact lenses worn first, with Nelfilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: First 10 Days |
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| Period 2: Second 10 Days |
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This analysis group includes all randomized subjects who had no major protocol violations excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Nelfilcon A and Etafilcon A toric contact lenses worn during Period 1 and Period 2, as randomized, in a crossover assignment. |
| 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 | High Contrast Time Controlled Visual Acuity (TCVA) at Day 10 | TCVA test was performed at 4 meters under high illumination (90%) using a Landolt ring test. For each acuity level, a series of single rings with gaps in one of four directions was presented and the percentage of correctly identified rings constituted the score. TCVA was measured in VA units and a higher TCVA value indicates an improvement in visual acuity. Both eyes contributed to the analysis. | This analysis group includes all randomized subjects who had no major protocol violations excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan. | Posted | Mean | Standard Deviation | VA units | Day 10, each product |
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Adverse events (AEs) were collected for the duration of the study (5 months). This analysis group includes all subjects exposed to investigational product based on treatment-specific exposure, as reported by the subject or observed by the investigator.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects whether or not related to the medical device. Note: 2 subjects were exposed to DACP T but not dispensed.
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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 | DACP T | Nelfilcon A toric contact lenses worn bilaterally on a daily wear, daily disposable basis for 10 days. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr Global Brand Lead, GCRA, Vision Care | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Etafilcon A toric contact lenses | Device |
|
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| OG001 | 1DAM A | Etafilcon A toric contact lenses worn bilaterally during Period 1 or Period 2 on a daily wear, daily disposable basis for 10 days. |
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| Secondary | Lens Oscillation at Blink at Day 10 | Lens oscillation (rotational stability of the lens on the eye) at blink was video-recorded. Digital images were used to measure the rotational characteristics of the lenses and objectively measure the amplitude of the lens oscillation. A higher value indicates greater lens movement on the eye. This outcome measure was collected at one site only. | This analysis group includes all randomized subjects at the UK site with data at visit who had no major protocol violations excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan. | Posted | Mean | Standard Deviation | degrees | Day 10, each product |
|
|
|
| 0 |
| 79 |
| 0 |
| 79 |
| EG001 | 1DAM A | Etafilcon A toric contact lenses worn bilaterally on a daily wear, daily disposable basis for 10 days. | 0 | 78 | 0 | 78 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.