Myopia
Conditions
Brief summary
The purpose of this study is to evaluate the performance of an investigational daily disposable contact lens.
Interventions
Investigational silicone hydrogel, single vision soft contact lens
Commercially marketed silicone hydrogel, single vision soft contact lens
Sponsors
CIBA VISION
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Subjects with normal eyes who are not using any ocular medications. * Be of legal age of consent and sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document. * Willing and able to wear spherical contact lenses for at least 5 days per week. * Willing and able to wear spherical contact lenses within the available range of powers of -1.00 diopter(D) to -6.00D in 0.25D steps. * Best spectacle-corrected visual acuity greater than or equal to 20/25. * Manifest cylinder less than or equal to 0.75D. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Any active anterior segment ocular disease that would contraindicate contact lens wear. * Any use of systemic medications for which contact lens wear could be contraindicated as determined by the investigator. * History of refractive surgery or irregular cornea. * History of pathologically dry eye. * Eye injury within twelve weeks immediately prior to enrollment for this trial. * Currently enrolled in any clinical trial. * Participation in a contact lens or contact lens care product clinical trial within the previous 30 days. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corrected Distance Monocular Visual Measurement in Normal Illumination Reported as Visual Acuity | 3 months of wear, lenses replaced daily | Each eye tested individually while reading a chart distant to the participant in normal lighting. Visual acuity was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. Visual acuity is reported as the number of eyes achieving 20/20 Snellen acuity or better. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Vision | 3 months of wear, lenses replaced daily | As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall vision was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. |
| Overall Comfort | 3 months of wear, lenses replaced daily | As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. |
| Overall Handling | 3 months of wear, lenses replaced daily | As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. |
Participant flow
Recruitment details
Participants were recruited and enrolled from six (6) US study centers.
Pre-assignment details
This reporting group includes all enrolled participants.
Participants by arm
| Arm | Count |
|---|---|
| Delefilcon A Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months. | 60 |
| Narafilcon B Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months. | 30 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not meet inclusion criteria | 1 | 0 |
| Overall Study | Met exclusion criteria | 1 | 0 |
Baseline characteristics
| Characteristic | Delefilcon A | Narafilcon B | Total |
|---|---|---|---|
| Age Continuous | 29.01 years STANDARD_DEVIATION 8.86 | 31.39 years STANDARD_DEVIATION 10.05 | 29.80 years STANDARD_DEVIATION 9.29 |
| Region of Enrollment United States | 60 participants | 30 participants | 90 participants |
| Sex: Female, Male Female | 40 Participants | 19 Participants | 59 Participants |
| Sex: Female, Male Male | 20 Participants | 11 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 60 | 0 / 30 |
| serious Total, serious adverse events | 0 / 60 | 1 / 30 |
Outcome results
Primary
Corrected Distance Monocular Visual Measurement in Normal Illumination Reported as Visual Acuity
Each eye tested individually while reading a chart distant to the participant in normal lighting. Visual acuity was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. Visual acuity is reported as the number of eyes achieving 20/20 Snellen acuity or better.
Time frame: 3 months of wear, lenses replaced daily
Population: Per protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Delefilcon A | Corrected Distance Monocular Visual Measurement in Normal Illumination Reported as Visual Acuity | 111 eyes |
| Narafilcon B | Corrected Distance Monocular Visual Measurement in Normal Illumination Reported as Visual Acuity | 58 eyes |
Secondary
Overall Comfort
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Time frame: 3 months of wear, lenses replaced daily
Population: Per protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Delefilcon A | Overall Comfort | 9.3 Units on a scale | Standard Deviation 0.9 |
| Narafilcon B | Overall Comfort | 8.9 Units on a scale | Standard Deviation 1.2 |
Secondary
Overall Handling
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Time frame: 3 months of wear, lenses replaced daily
Population: Per protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Delefilcon A | Overall Handling | 9.1 Units on a scale | Standard Deviation 1.3 |
| Narafilcon B | Overall Handling | 9.1 Units on a scale | Standard Deviation 1.2 |
Secondary
Overall Vision
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall vision was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Time frame: 3 months of wear, lenses replaced daily
Population: Per protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Delefilcon A | Overall Vision | 9.5 Units on a scale | Standard Deviation 0.8 |
| Narafilcon B | Overall Vision | 9.1 Units on a scale | Standard Deviation 1.1 |