Myopia
Conditions
Keywords
refractive error
Brief summary
This study seeks to evaluate the clinical performance of a new CE marked daily disposable contact lens that contains a wetting agent to a recently improved daily disposable contact lens.
Interventions
DEVICEnelfilcon A
spherical soft contact lens
DEVICEnarafilcon A
spherical soft contact lens
Sponsors
Visioncare Research Ltd.
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* They are of legal age (18 years) and capacity to volunteer. * They understand their rights as a research subject and are willing to sign a Statement of Informed Consent. * They are willing and able to follow the protocol. * They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses. * They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS. * They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC). * They have successfully worn contact lenses within six months of starting the study.
Exclusion criteria
* They have an ocular disorder which would normally contra-indicate contact lens wear. * They have a systemic disorder which would normally contra-indicate contact lens wear. * They are using any topical medication such as eye drops or ointment. * They are aphakic. * They have had corneal refractive surgery. * They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus. * They are pregnant or lactating. * They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear. * They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV). * They have diabetes. * They have taken part in any other clinical trial or research, within two weeks prior to starting this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Comfort | at 1 week of wear. | Single question: Comfort scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent |
| Measured Limbal Hyperemia | at 1 week of wear. | Measurement of redness of the limbus, graded using half-grade increments using the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| End of Day Comfort | at 1 week of wear | Rating of comfort at the end of the day using the following scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent |
| Overall Handling | at 1 week of wear | Rating of overall ease of handling using the following scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent. |
| Inferior Region Corneal Staining | at 1 week of wear | National Eye Institute (NEI) 0-3 scale: grade 0=normal, grade 1=mild, grade 2=moderate, grade 3=severe. |
| Initial Comfort | at 1 week | Rating of comfort immediately when you first put them on using the following scale: 0=N/A, 1= Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent. |
| How Comfortable Eyes Feel at the End of the Day | at 1 week wear | Rating of How comfortable did your eyes feel at the end of the day when wearing the contact lenses provided using the following scale: 1=extremely uncomfortable, 2= very uncomfortable, 3=slightly uncomfortable, 4=comfortable, 5=very comfortable. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Narafilcon A soft contact lens worn as a daily disposable modality for one week | 125 |
| Nelfilcon A soft contact lens worn as a daily disposable modality for one week | 118 |
| Total | 243 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lens issue | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Subject unable to return for follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Narafilcon A | Nelfilcon A | Total |
|---|---|---|---|
| Age, Continuous | 33.0 years STANDARD_DEVIATION 9.5 | 32.9 years STANDARD_DEVIATION 10.6 | 33.0 years STANDARD_DEVIATION 10 |
| Region of Enrollment United Kingdom | 125 participants | 118 participants | 243 participants |
| Sex: Female, Male Female | 90 Participants | 92 Participants | 182 Participants |
| Sex: Female, Male Male | 35 Participants | 26 Participants | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 127 | 0 / 121 |
| serious Total, serious adverse events | 0 / 127 | 0 / 121 |
Outcome results
Primary
Measured Limbal Hyperemia
Measurement of redness of the limbus, graded using half-grade increments using the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.
Time frame: at 1 week of wear.
Population: Analysis includes participants who completed the study per protocol and had no missing data (n=243).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Narafilcon A | Measured Limbal Hyperemia | 0.364 Units on a scale | Standard Error 0.05494 |
| Nelfilcon A | Measured Limbal Hyperemia | 0.5374 Units on a scale | Standard Error 0.0558 |
Comparison: Alternative hypothesis: narafilcon A is superior to nelfilcon A.97.47% CI: [-0.1734, -0.1037]Mixed Models Analysis
Primary
Overall Comfort
Single question: Comfort scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent
Time frame: at 1 week of wear.
Population: Analysis includes participants who completed the protocol and had no missing data (n=240)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Narafilcon A | Overall Comfort | 3.903 Units on a scale | Standard Error 0.1446 |
| Nelfilcon A | Overall Comfort | 3.349 Units on a scale | Standard Error 0.1389 |
Comparison: Alternative hypothesis: narafilcon A is superior to nelfilcon A97.47% CI: [0.1721, 0.554]Mixed Models Analysis
Secondary
End of Day Comfort
Rating of comfort at the end of the day using the following scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent
Time frame: at 1 week of wear
Population: Analysis includes participants who completed the study per protocol and had no missing data (n=240).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Narafilcon A | End of Day Comfort | 3.425 Units on a scale | Standard Error 0.129 |
| Nelfilcon A | End of Day Comfort | 2.7515 Units on a scale | Standard Error 0.1269 |
Comparison: Alternative hypothesis: narafilcon A is superior to nelfilcon A98.7% CI: [0.213, 0.6735]Mixed Models Analysis
Secondary
How Comfortable Eyes Feel at the End of the Day
Rating of How comfortable did your eyes feel at the end of the day when wearing the contact lenses provided using the following scale: 1=extremely uncomfortable, 2= very uncomfortable, 3=slightly uncomfortable, 4=comfortable, 5=very comfortable.
Time frame: at 1 week wear
Population: Analysis includes participants who completed the study per protocol and had no missing data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Narafilcon A | How Comfortable Eyes Feel at the End of the Day | 3.8669 Units on a scale | Standard Error 0.1546 |
| Nelfilcon A | How Comfortable Eyes Feel at the End of the Day | 3.4794 Units on a scale | Standard Error 0.1487 |
Comparison: Alternative hypothesis: narafilcon A is superior to nelfilcon A.98.7% CI: [0.03714, 0.3875]Mixed Models Analysis
Secondary
Inferior Region Corneal Staining
National Eye Institute (NEI) 0-3 scale: grade 0=normal, grade 1=mild, grade 2=moderate, grade 3=severe.
Time frame: at 1 week of wear
Population: Analysis includes participants who completed the study per protocol and had no missing data (n=243).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Narafilcon A | Inferior Region Corneal Staining | 0.311 Units on a scale | Standard Error 0.03884 |
| Nelfilcon A | Inferior Region Corneal Staining | 0.5579 Units on a scale | Standard Error 0.03974 |
Comparison: Alternative hypothesis: narafilcon A is superior to nelfilcon A by having a lower level of inferior region corneal staining97.47% CI: [-0.2469, -0.1599]Mixed Models Analysis
Secondary
Initial Comfort
Rating of comfort immediately when you first put them on using the following scale: 0=N/A, 1= Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent.
Time frame: at 1 week
Population: Analysis includes participants who completed the study per protocol and had no missing data (n=240).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Narafilcon A | Initial Comfort | 4.0306 Units on a scale | Standard Error 0.1352 |
| Nelfilcon A | Initial Comfort | 3.8986 Units on a scale | Standard Error 0.1312 |
Comparison: Alternative hypothesis: narafilcon A is superior to nelfilcon A98.7% CI: [-0.2375, 0.132]Mixed Models Analysis
Secondary
Overall Handling
Rating of overall ease of handling using the following scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent.
Time frame: at 1 week of wear
Population: Analysis includes participants who completed the study per protocol and had no missing data (n=240).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Narafilcon A | Overall Handling | 4.0959 Units on a scale | Standard Error 0.1209 |
| Nelfilcon A | Overall Handling | 3.6991 Units on a scale | Standard Error 0.1172 |
Comparison: Alternative hypothesis: narafilcon A is superior to nelfilcon A98.7% CI: [0.04983, 0.3968]Mixed Models Analysis