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The purpose of this study was to evaluate the axis location of toric contact lenses after 3 minutes of wear. During this 1-visit study, each participant wore 3 pairs of study lenses of various design iterations (2-87-1, 2-87-2, 2-87-3) for an exposure time of approximately 30 minutes each. Each pair consisted of lenses of the same design iteration, 1 lens with embossed mark [TEST1 (T1), TEST3 (T3), TEST5 (T5)], worn on the right eye, and 1 lens without embossed mark [TEST2 (T2), TEST4 (T4), and TEST6 (T6)] worn on the left eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iteration 2-87-1 | Experimental | Delefilcon A toric contact lenses T1 and T2 worn contralaterally (1 in each eye) for approximately 30 minutes |
|
| Iteration 2-87-2 | Experimental | Delefilcon A toric contact lenses T3 and T4 worn contralaterally (1 in each eye) for approximately 30 minutes |
|
| Iteration 2-87-3 | Experimental | Delefilcon A toric contact lenses T5 and T6 worn contralaterally (1 in each eye) for approximately 30 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delefilcon A toric contact lens T1 | Device | Iteration 2-87-1 with embossed mark |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Lenses With Axis Orientation ≤ 10 Degrees From Ideal Location After 3 Minutes of Wear | Axis orientation (the rotational positioning of the lens on the eye) was indicated by an axis mark. The actual location of the axis mark was evaluated during slit lamp review and compared to the ideal location for the axis mark, with the difference measured in degrees (0 to +/- 180). The ideal location for the axis mark was iteration-specific (either 6 o'clock or 3 and 9 o'clock). This outcome measure was pre-specified for the embossed lenses only (TEST1, TEST3, and TEST5). | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Lens Awareness | Lens awareness was assessed by the participant on a 5-point scale (0=none and 4=severe) within the first 5 minutes of wear for each eye separately. | Day 1 |
| Handling on Removal | Handling on removal (after 30 minutes of wear) was assessed by the participant on a scale from 1 to 10 (1=poor and 10=excellent). This outcome measure was pre-specified for the embossed lenses only (TEST1, TEST3, and TEST5). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joachim Nick, Dipl. Ing. | Alcon Research | Study Director |
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Of the 50 enrolled, 1 participant was exited as a screen failure prior to randomization and exposure to the study product. This reporting group includes all randomized participants (49).
Participants were recruited from 1 study center located in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | T1 and T2; T3 and T4; T5 and T6 |
| FG001 | Sequence 2 | T1 and T2; T5 and T6; T3 and T4 |
| FG002 | Sequence 3 | T3 and T4; T1 and T2; T5 and T6 |
| FG003 | Sequence 4 | T3 and T4; T5 and T6; T1 and T2 |
| FG004 | Sequence 5 | T5 and T6; T1 and T2; T3 and T4 |
| FG005 | Sequence 6 | T5 and T6; T3 and T4; T1 and T2 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Exposure Pair 1, 30 Minutes |
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| Exposure Pair 2, 30 Minutes |
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| Exposure Pair 3, 30 Minutes |
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This analysis population includes all subjects/eyes exposed to the investigational products (embossed or non-embossed lenses).
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | All treatment sequences |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Percentage of Lenses With Axis Orientation ≤ 10 Degrees From Ideal Location After 3 Minutes of Wear | Axis orientation (the rotational positioning of the lens on the eye) was indicated by an axis mark. The actual location of the axis mark was evaluated during slit lamp review and compared to the ideal location for the axis mark, with the difference measured in degrees (0 to +/- 180). The ideal location for the axis mark was iteration-specific (either 6 o'clock or 3 and 9 o'clock). This outcome measure was pre-specified for the embossed lenses only (TEST1, TEST3, and TEST5). | This analysis population includes all all randomized participants satisfying all of the inclusion/exclusion criteria. | Posted | Number | percentage of lenses | Day 1 |
|
Adverse events (AEs) were collected for the duration of the study (18 days). This analysis group includes all participants/eyes exposed to the investigational products (embossed or non-embossed lenses).
AEs were defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the investigational medical device.
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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 | TEST (1,3,5) | Delefilcon A toric contact lenses with embossed mark, 3 different iterations, crossover all on the same eye |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joachim Nick, Dipl.-Ing. (FH), Clinical Lead | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D001251 | Astigmatism |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Delefilcon A toric contact lens T2 |
| Device |
Iteration 2-87-1 without embossed mark |
|
| Delefilcon A toric contact lens T3 | Device | Iteration 2-87-2 with embossed mark |
|
| Delefilcon A toric contact lens T4 | Device | Iteration 2-87-2 without embossed mark |
|
| Delefilcon A toric contact lens T5 | Device | Iteration 2-87-3 with embossed mark |
|
| Delefilcon A toric contact lens T6 | Device | Iteration 2-87-3 without embossed mark |
|
| Day 1 |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| TEST3 |
Iteration 2-87-2 with embossed mark |
| OG002 | TEST5 | Iteration 2-87-3 with embossed mark |
|
|
| Secondary | Lens Awareness | Lens awareness was assessed by the participant on a 5-point scale (0=none and 4=severe) within the first 5 minutes of wear for each eye separately. | This analysis population includes all all randomized participants satisfying all of the inclusion/exclusion criteria. | Posted | Mean | Standard Deviation | units on a scale | Day 1 |
|
|
|
| Secondary | Handling on Removal | Handling on removal (after 30 minutes of wear) was assessed by the participant on a scale from 1 to 10 (1=poor and 10=excellent). This outcome measure was pre-specified for the embossed lenses only (TEST1, TEST3, and TEST5). | This analysis population includes all all randomized participants satisfying all of the inclusion/exclusion criteria. | Posted | Mean | Standard Deviation | units on a scale | Day 1 |
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | TEST (2,4,6) | Delefilcon A toric contact lenses without embossed mark, 3 different iterations, crossover all on the same eye | 0 | 49 | 0 | 49 |
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