Refractive Error
Conditions
Keywords
astigmatism, toric, contact lenses, daily disposable contact lenses, molded mark, rotation mark
Brief summary
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.
Detailed description
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.
Interventions
DEVICEDelefilcon A spherical contact lens with molded marks
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.
Hydrogel toric contact lens for daily wear, daily disposable use
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Sign Informed Consent document. * Best corrected distance visual acuity (VA) greater than or equal to 20/25 in each eye. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* History of any ocular surgery or ocular injury within 12 weeks of study enrollment. * Any ocular disease, infection, inflammation, or abnormality that contraindicates contact lens (CL) wear. * History of herpetic keratitis. * Slit-lamp findings greater than grade 2 at baseline. * Any use of systemic or ocular medications for which CL wear could be contraindicated. * Inactive corneal neovascularization greater than 1 millimeter of penetration. * A clinically significant dry eye not responding to treatment. * History of refractive surgery. * Participation in a clinical study within the previous 30 days. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visibility of Rotation Mark (Clearly Visible, Slightly Visible Acceptable) | Day 1 | 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. |
Participant flow
Recruitment details
Participants were recruited from 1 US study center.
Pre-assignment details
This reporting group includes all enrolled participants.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 3 |
| Total | 3 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Continuous | 46.0 years STANDARD_DEVIATION 21.3 |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 3 | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 |
Outcome results
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.
Time frame: Day 1
Population: The analysis population includes all enrolled participants. Assessments from all 10 investigators were analyzed, hence sample size for each rotational mark is 30.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| S1 Mark | Visibility of Rotation Mark (Clearly Visible, Slightly Visible Acceptable) | 42.9 Percentage of assessments |
| S2 Mark | Visibility of Rotation Mark (Clearly Visible, Slightly Visible Acceptable) | 71.4 Percentage of assessments |
| S3 Mark | Visibility of Rotation Mark (Clearly Visible, Slightly Visible Acceptable) | 78.6 Percentage of assessments |
| S4 Mark | Visibility of Rotation Mark (Clearly Visible, Slightly Visible Acceptable) | 46.4 Percentage of assessments |
| S5 Mark | Visibility of Rotation Mark (Clearly Visible, Slightly Visible Acceptable) | 71.4 Percentage of assessments |
| S6 Mark | Visibility of Rotation Mark (Clearly Visible, Slightly Visible Acceptable) | 82.1 Percentage of assessments |
| S7 Mark | Visibility of Rotation Mark (Clearly Visible, Slightly Visible Acceptable) | 78.6 Percentage of assessments |
| S8 Mark | Visibility of Rotation Mark (Clearly Visible, Slightly Visible Acceptable) | 75.0 Percentage of assessments |
| Control | Visibility of Rotation Mark (Clearly Visible, Slightly Visible Acceptable) | 93.3 Percentage of assessments |