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The purpose of this study was to select the size of the molded rotation mark for a new toric contact lens by comparing the visibility of various molded rotation marks.
Participants wore the test and control products contralaterally (in each eye separately) for 2 hours, during which the Investigator assessed the various molded rotation marks for visibility. Each participant was assessed by 10 investigators.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delefilcon A | Experimental | Delefilcon A spherical contact lens with molded marks randomly assigned to one eye, with etafilcon A toric contact lens in the fellow eye for contralateral wear approximately 2 hours in duration |
|
| Etafilcon A | Other | Etafilcon A toric contact lens randomly assigned to one eye, with delefilcon A spherical contact lens with molded marks in the fellow eye for contralateral wear approximately 2 hours in duration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delefilcon A spherical contact lens with molded marks | Device | Silicone hydrogel contact lens with 9 different molded marks of varying widths and depths indented into the front surface (S1, S2, S3, S4, S5, S6, S7, S8, and S9). Each lens contained all 9 marks. |
| Measure | Description | Time Frame |
|---|---|---|
| Visibility of Rotation Mark (Clearly Visible, Slightly Visible Acceptable) | Each lens (containing 8 rotation marks and one reference mark, in total 9 marks) was assessed for visibility by 10 investigators using the following scale: "N/A;" "Not visible;" "Slightly visible, not acceptable;" "Slightly visible, acceptable;" "Clearly visible;" "More visible than necessary." Visibility assessments were made after all marks had been evaluated. S9 Mark (test lens) functioned as a starting marker only and was not rated. The control lens was not used as a comparison, but rather as a reference for what a mark looks like on a commercial product. "Visibility of Rotation Mark" is reported as the percentage of assessments rating the rotation mark as "Clearly visible" or "Slightly visible, acceptable." | Day 1 |
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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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This reporting group includes all enrolled participants.
Participants were recruited from 1 US study center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study | Delefilcon A spherical contact lens with molded marks and etafilcon A toric contact lens worn contralaterally (1 in each eye) for approximately 2 hours |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The analysis population includes all enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Delefilcon A spherical contact lens with molded marks and etafilcon A toric contact lens worn contralaterally (1 in each eye) for approximately 2 hours |
| 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 | Visibility of Rotation Mark (Clearly Visible, Slightly Visible Acceptable) | Each lens (containing 8 rotation marks and one reference mark, in total 9 marks) was assessed for visibility by 10 investigators using the following scale: "N/A;" "Not visible;" "Slightly visible, not acceptable;" "Slightly visible, acceptable;" "Clearly visible;" "More visible than necessary." Visibility assessments were made after all marks had been evaluated. S9 Mark (test lens) functioned as a starting marker only and was not rated. The control lens was not used as a comparison, but rather as a reference for what a mark looks like on a commercial product. "Visibility of Rotation Mark" is reported as the percentage of assessments rating the rotation mark as "Clearly visible" or "Slightly visible, acceptable." | The analysis population includes all enrolled participants. Assessments from all 10 investigators were analyzed, hence sample size for each rotational mark is 30. | Posted | Number | Percentage of assessments | Day 1 |
|
Adverse events were collected for the duration of the study (1 day).
The analysis population includes includes all enrolled 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 | Delefilcon A spherical contact lens with molded marks randomly assigned to one eye, with etafilcon A toric contact lens in the fellow eye for contralateral wear approximately 2 hours in duration. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joachim Nick, Dipl. Ing. | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Etafilcon A toric contact lens | Device | Hydrogel toric contact lens for daily wear, daily disposable use |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| S1 Mark |
Delefilcon A spherical contact lens with 1 of 9 molded marks |
| OG001 | S2 Mark | Delefilcon A spherical contact lens with 1 of 9 molded marks |
| OG002 | S3 Mark | Delefilcon A spherical contact lens with 1 of 9 molded marks |
| OG003 | S4 Mark | Delefilcon A spherical contact lens with 1 of 9 molded marks |
| OG004 | S5 Mark | Delefilcon A spherical contact lens with 1 of 9 molded marks |
| OG005 | S6 Mark | Delefilcon A spherical contact lens with 1 of 9 molded marks |
| OG006 | S7 Mark | Delefilcon A spherical contact lens with 1 of 9 molded marks |
| OG007 | S8 Mark | Delefilcon A spherical contact lens with 1 of 9 molded marks |
| OG008 | Control | Etafilcon A toric contact lens |
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Etafilcon A | Etafilcon A toric contact lens randomly assigned to one eye, with delefilcon A spherical contact lens with molded marks in the fellow eye for contralateral wear approximately 2 hours in duration | 0 | 3 | 0 | 3 |
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