Myopia
Conditions
Brief summary
The purpose of this 4-week dispensing trial is to evaluate and compare an investigational soft contact lens worn on a daily disposable basis with three other soft contact lenses also worn on a daily disposable basis.
Interventions
Investigational silicone hydrogel, single vision contact lens for daily wear, daily disposable use
DEVICELotrafilcon B contact lens (O2 OPTIX, AIR OPTIX)
Commercially marketed silicone hydrogel, single vision contact lens for daily wear, daily disposable use
DEVICENelfilcon A contact lens (DAILIES AquaComfort Plus)
Commercially marketed hydrogel, single vision contact lens for daily wear, daily disposable use
DEVICENarafilcon A contact lens (1-DAY ACUVUE TRUEYE)
Commercially marketed (Europe) silicone hydrogel, single vision contact lens for daily wear, daily disposable use
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
* Germany: Be of legal age. * USA: Be of legal age or, if under legal age, have written consent of parent/guardian to participate and sign informed assent. * Sign Informed Consent. * Wear soft contact lenses for at least 3 months prior to the study. * Wear soft contact lenses on a daily disposable basis, daily wear basis, or occasional extended wear basis. * Other protocol-defined inclusion/
Exclusion criteria
may apply.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Daily Wear Time | 4 weeks | Average daily wear time (hours) was reported by the participant as a single, retrospective evaluation of 4 weeks of wear. |
| Vision Quality During the Day | 4 weeks | Vision quality during the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Vision quality during the day was measured on a 10-point scale, with 1 being poor and 10 being excellent. |
| Overall Handling | 4 weeks | Overall handling was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall handling was measured on a 10-point scale, with 1 being poor and 10 being excellent. |
| Dryness Throughout the Day | 4 weeks | Dryness throughout the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Dryness throughout the day was measured on a 10-point scale, with 1 being very dry and 10 being not dry. |
| Overall Comfort | 4 weeks | Overall comfort was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Corrected Visual Acuity | 4 weeks | Corrected visual acuity was tested for each eye while the participant read distant charts in normal lighting. Corrected visual acuity was measured with a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity. |
| Overall Satisfaction | 4 weeks | Overall satisfaction was recorded on a 5-point Likert scale as a single, retrospective evaluation of 4 weeks of wear. The following scale was used: 2=very satisfied, 1=somewhat satisfied, 0=neither, -1=somewhat dissatisfied, and -2=very dissatisfied. |
| Lens Fit | 4 weeks | Lens fit was assessed by the investigator for each eye using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded on a 5-point scale, with 2=unacceptable loose, 1=acceptable loose, 0=optimal, -1=acceptable tight, and -2=unacceptable tight. |
Countries
Germany, United States
Participant flow
Recruitment details
Participants were recruited and enrolled from 1 US study center and 1 German study center.
Pre-assignment details
This reporting group includes all enrolled and dispensed participants (129). One US participant was enrolled, but not dispensed.
Participants by arm
| Arm | Count |
|---|---|
| Delefilcon A Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks. | 40 |
| Lotrafilcon B Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks. | 29 |
| Nelfilcon A Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks. | 30 |
| Narafilcon A Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks. | 30 |
| Total | 129 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Biomicroscopy | 0 | 0 | 1 | 0 |
| Overall Study | Difficult removal handling | 0 | 0 | 1 | 0 |
| Overall Study | Discomfort | 0 | 4 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 |
| Overall Study | Symptoms and problems | 0 | 2 | 1 | 0 |
| Overall Study | Unacceptable subjective vision | 0 | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | Delefilcon A | Lotrafilcon B | Nelfilcon A | Narafilcon A | Total |
|---|---|---|---|---|---|
| Age Continuous | 35.7 years STANDARD_DEVIATION 10.4 | 35.6 years STANDARD_DEVIATION 11.4 | 38.4 years STANDARD_DEVIATION 10.6 | 37.0 years STANDARD_DEVIATION 11.4 | 36.6 years STANDARD_DEVIATION 10.8 |
| Sex: Female, Male Female | 32 Participants | 19 Participants | 24 Participants | 20 Participants | 95 Participants |
| Sex: Female, Male Male | 8 Participants | 10 Participants | 6 Participants | 10 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 5 / 29 | 2 / 30 | 2 / 30 |
| serious Total, serious adverse events | 0 / 40 | 0 / 29 | 0 / 30 | 0 / 30 |
Outcome results
Primary
Average Daily Wear Time
Average daily wear time (hours) was reported by the participant as a single, retrospective evaluation of 4 weeks of wear.
Time frame: 4 weeks
Population: Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Delefilcon A | Average Daily Wear Time | 13.8 Hours | Standard Deviation 2.2 |
| Lotrafilcon B | Average Daily Wear Time | 13.8 Hours | Standard Deviation 2.1 |
| Nelfilcon A | Average Daily Wear Time | 14.2 Hours | Standard Deviation 1.8 |
| Narafilcon A | Average Daily Wear Time | 13.8 Hours | Standard Deviation 1.6 |
Primary
Dryness Throughout the Day
Dryness throughout the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Dryness throughout the day was measured on a 10-point scale, with 1 being very dry and 10 being not dry.
Time frame: 4 weeks
Population: Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Delefilcon A | Dryness Throughout the Day | 9.5 Units on a scale | Standard Deviation 0.6 |
| Lotrafilcon B | Dryness Throughout the Day | 7.7 Units on a scale | Standard Deviation 2 |
| Nelfilcon A | Dryness Throughout the Day | 9.0 Units on a scale | Standard Deviation 1.5 |
| Narafilcon A | Dryness Throughout the Day | 8.5 Units on a scale | Standard Deviation 1.5 |
Primary
Overall Comfort
Overall comfort was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Time frame: 4 weeks
Population: Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Delefilcon A | Overall Comfort | 9.5 Units on a scale | Standard Deviation 0.7 |
| Lotrafilcon B | Overall Comfort | 7.9 Units on a scale | Standard Deviation 1.6 |
| Nelfilcon A | Overall Comfort | 9.0 Units on a scale | Standard Deviation 0.9 |
| Narafilcon A | Overall Comfort | 8.6 Units on a scale | Standard Deviation 1.2 |
Primary
Overall Handling
Overall handling was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall handling was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Time frame: 4 weeks
Population: Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Delefilcon A | Overall Handling | 9.3 Units on a scale | Standard Deviation 0.9 |
| Lotrafilcon B | Overall Handling | 8.5 Units on a scale | Standard Deviation 1.4 |
| Nelfilcon A | Overall Handling | 9.3 Units on a scale | Standard Deviation 0.9 |
| Narafilcon A | Overall Handling | 9.1 Units on a scale | Standard Deviation 1.3 |
Primary
Vision Quality During the Day
Vision quality during the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Vision quality during the day was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Time frame: 4 weeks
Population: Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Delefilcon A | Vision Quality During the Day | 9.6 Units on a scale | Standard Deviation 0.6 |
| Lotrafilcon B | Vision Quality During the Day | 8.8 Units on a scale | Standard Deviation 1.2 |
| Nelfilcon A | Vision Quality During the Day | 9.5 Units on a scale | Standard Deviation 0.9 |
| Narafilcon A | Vision Quality During the Day | 8.7 Units on a scale | Standard Deviation 1.3 |
Secondary
Corrected Visual Acuity
Corrected visual acuity was tested for each eye while the participant read distant charts in normal lighting. Corrected visual acuity was measured with a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity.
Time frame: 4 weeks
Population: Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Delefilcon A | Corrected Visual Acuity | -0.06 logMAR | Standard Deviation 0.04 |
| Lotrafilcon B | Corrected Visual Acuity | -0.04 logMAR | Standard Deviation 0.06 |
| Nelfilcon A | Corrected Visual Acuity | -0.07 logMAR | Standard Deviation 0.05 |
| Narafilcon A | Corrected Visual Acuity | -0.06 logMAR | Standard Deviation 0.06 |
Secondary
Lens Fit
Lens fit was assessed by the investigator for each eye using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded on a 5-point scale, with 2=unacceptable loose, 1=acceptable loose, 0=optimal, -1=acceptable tight, and -2=unacceptable tight.
Time frame: 4 weeks
Population: Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Delefilcon A | Lens Fit | 0.1 Units on a scale | Standard Deviation 0.3 |
| Lotrafilcon B | Lens Fit | 0.1 Units on a scale | Standard Deviation 0.6 |
| Nelfilcon A | Lens Fit | 0.1 Units on a scale | Standard Deviation 0.6 |
| Narafilcon A | Lens Fit | -0.6 Units on a scale | Standard Deviation 0.7 |
Secondary
Overall Satisfaction
Overall satisfaction was recorded on a 5-point Likert scale as a single, retrospective evaluation of 4 weeks of wear. The following scale was used: 2=very satisfied, 1=somewhat satisfied, 0=neither, -1=somewhat dissatisfied, and -2=very dissatisfied.
Time frame: 4 weeks
Population: Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Delefilcon A | Overall Satisfaction | 1.4 Units on a scale | Standard Deviation 1.3 |
| Lotrafilcon B | Overall Satisfaction | 0.6 Units on a scale | Standard Deviation 1.4 |
| Nelfilcon A | Overall Satisfaction | 1.5 Units on a scale | Standard Deviation 0.8 |
| Narafilcon A | Overall Satisfaction | 1.1 Units on a scale | Standard Deviation 1 |