Astigmatism, Myopia, Refractive Error
Conditions
Keywords
Contact Lens, Toric
Brief summary
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.
Interventions
DEVICEDelefilcon A toric contact lens T1
Iteration 2-87-1 with embossed mark
DEVICEDelefilcon A toric contact lens T2
Iteration 2-87-1 without embossed mark
DEVICEDelefilcon A toric contact lens T3
Iteration 2-87-2 with embossed mark
DEVICEDelefilcon A toric contact lens T4
Iteration 2-87-2 without embossed mark
DEVICEDelefilcon A toric contact lens T5
Iteration 2-87-3 with embossed mark
DEVICEDelefilcon A toric contact lens T6
Iteration 2-87-3 without embossed mark
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Sign written Informed Consent. * Best corrected distance visual acuity 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 enrollment for this study. * Anterior segment disease, infection, inflammation, or abnormality that contraindicates contact lens wear. * History of herpetic keratitis. * Slit-lamp findings at baseline as specified in the protocol. * Any use of systemic or ocular medications for which contact lens wear could be contraindicated, including ocular medications that require instillation during contact lens wear. * Clinically significant dry eye not responding to treatment. * History of refractive surgery. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Lenses With Axis Orientation ≤ 10 Degrees From Ideal Location After 3 Minutes of Wear | Day 1 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lens Awareness | Day 1 | 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. |
| Handling on Removal | Day 1 | 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). |
Participant flow
Recruitment details
Participants were recruited from 1 study center located in the US.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| Overall All treatment sequences | 49 |
| Total | 49 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Customized 18 - 68 Years | 45.4 years STANDARD_DEVIATION 13.6 |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 49 | 0 / 49 |
| serious Total, serious adverse events | 0 / 49 | 0 / 49 |
Outcome results
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).
Time frame: Day 1
Population: This analysis population includes all all randomized participants satisfying all of the inclusion/exclusion criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TEST1 | Percentage of Lenses With Axis Orientation ≤ 10 Degrees From Ideal Location After 3 Minutes of Wear | 24.5 percentage of lenses |
| TEST3 | Percentage of Lenses With Axis Orientation ≤ 10 Degrees From Ideal Location After 3 Minutes of Wear | 46.9 percentage of lenses |
| TEST5 | Percentage of Lenses With Axis Orientation ≤ 10 Degrees From Ideal Location After 3 Minutes of Wear | 36.7 percentage of lenses |
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).
Time frame: Day 1
Population: This analysis population includes all all randomized participants satisfying all of the inclusion/exclusion criteria.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TEST1 | Handling on Removal | 8.0 units on a scale | Standard Deviation 2.4 |
| TEST3 | Handling on Removal | 7.8 units on a scale | Standard Deviation 2.6 |
| TEST5 | Handling on Removal | 8.9 units on a scale | Standard Deviation 1.8 |
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.
Time frame: Day 1
Population: This analysis population includes all all randomized participants satisfying all of the inclusion/exclusion criteria.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TEST1 | Lens Awareness | 0.6 units on a scale | Standard Deviation 0.8 |
| TEST3 | Lens Awareness | 0.2 units on a scale | Standard Deviation 0.5 |
| TEST5 | Lens Awareness | 0.4 units on a scale | Standard Deviation 0.7 |
| TEST4 | Lens Awareness | 0.2 units on a scale | Standard Deviation 0.4 |
| TEST5 | Lens Awareness | 1.0 units on a scale | Standard Deviation 1.1 |
| TEST6 | Lens Awareness | 0.6 units on a scale | Standard Deviation 0.7 |