Myopia
Conditions
Brief summary
The purpose of this study is to validate the improvements to the inversion indicator.
Detailed description
This study was conducted in three countries under three separate protocols: P-346-C-009 sub 02 (UK), P-346-C-009 sub 03 (Germany), and P-346-C-010 (USA). The data reported represents pooled data from the three protocols.
Interventions
DEVICEnelfilcon A contact lens, modified inversion indicator
Investigational, nelfilcon A, toric, soft contact lens for daily disposable wear, with modified inversion indicator
DEVICEnelfilcon A contact lens, no inversion indicator
Investigational, nelfilcon A, toric, soft contact lens for daily disposable wear, with no inversion indicator
DEVICEnelfilcon A contact lens, inversion indicator
Commercially marketed, nelfilcon A, toric, soft contact lens for daily disposable wear, with inversion indicator
Sponsors
CIBA VISION
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Be of legal age and sign written Informed Consent Document. If under legal age, parent or guardian must sign Informed Consent Document and subjects ages 12 through 17 must sign Informed Assent. * Willing and able to wear study lenses in both eyes in the available parameters. * Light-eyed subjects. * Able to achieve 20/40 or better distance visual acuity (VA) in each eye at time of dispensing. * Optimal or acceptable fit in each eye at time of dispensing. * Willing to wear the study lenses at least 8 hours a day, 5 days a week. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Eye injury or surgery within twelve weeks prior to enrollment for this trial. * Pre-existing ocular irritation that would preclude contact lens fitting. * Currently enrolled in an ophthalmic clinical trial. * Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of their accessory solutions as determined by the investigator. * Any use of medications for which contact lens wear could be contraindicated as determined by the investigator. * RGP contact lens wearer. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visibility of the Inversion Indicator on Lens When Lens Was on Participant's Finger, for Example, During Lens Insertion. | 1 week | As assessed by the participant retrospectively after one week of wear and recorded on a questionnaire as a yes or no response to the question, Did you notice an OK mark on the study lens while it was on your finger, for example, during lens insertion? The positive yes responses are reported. |
Participant flow
Pre-assignment details
This reporting group includes all enrolled and dispensed participants. Note: One subject was enrolled but not dispensed due to failing inclusion/exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Nelfilcon A, Modified Inversion Indicator nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week | 90 |
| Nelfilcon A, No Inversion Indicator nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week | 98 |
| Nelfilcon A, Inversion Indicator nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week. | 91 |
| Total | 279 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Did not return for final visit | 0 | 0 | 1 |
| Overall Study | Discomfort | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Nelfilcon A, Modified Inversion Indicator | Nelfilcon A, No Inversion Indicator | Nelfilcon A, Inversion Indicator | Total |
|---|---|---|---|---|
| Age Continuous | 36.2 years STANDARD_DEVIATION 10.6 | 33.3 years STANDARD_DEVIATION 11.7 | 34.1 years STANDARD_DEVIATION 10.8 | 34.5 years STANDARD_DEVIATION 11.1 |
| Sex: Female, Male Female | 52 Participants | 69 Participants | 69 Participants | 190 Participants |
| Sex: Female, Male Male | 38 Participants | 29 Participants | 22 Participants | 89 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 90 | 13 / 98 | 13 / 92 |
| serious Total, serious adverse events | 0 / 90 | 0 / 98 | 0 / 92 |
Outcome results
Primary
Visibility of the Inversion Indicator on Lens When Lens Was on Participant's Finger, for Example, During Lens Insertion.
As assessed by the participant retrospectively after one week of wear and recorded on a questionnaire as a yes or no response to the question, Did you notice an OK mark on the study lens while it was on your finger, for example, during lens insertion? The positive yes responses are reported.
Time frame: 1 week
Population: Analysis conducted per protocol, with exclusions due to protocol deviations as determined by masked review (9), and unavailable data due to discontinuations (3).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nelfilcon A, Modified Inversion Indicator | Visibility of the Inversion Indicator on Lens When Lens Was on Participant's Finger, for Example, During Lens Insertion. | 77 participants |
| Nelfilcon A, No Inversion Indicator | Visibility of the Inversion Indicator on Lens When Lens Was on Participant's Finger, for Example, During Lens Insertion. | 15 participants |
| Nelfilcon A, Inversion Indicator | Visibility of the Inversion Indicator on Lens When Lens Was on Participant's Finger, for Example, During Lens Insertion. | 84 participants |