Myopia
Conditions
Brief summary
The objective of this study is to evaluate the clinical performance of two daily disposable contact lenses.
Interventions
DEVICEetafilcon A
Contact Lens
DEVICEnelfilcon A
Contact Lens
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Age: 18 years to 45 years * Current daily soft contact lens as habitual optical correction: * Refraction: * Best sphere (corrected for back vertex distance) -1.00 to -6.00D * Cylinder 0.00 to - 0.75D * Best spectacle corrected visual acuity of 6/9 or better in each eye * Willingness to adhere to the instructions set in the clinical protocol * Signature of the subject on the informed consent form
Exclusion criteria
* Systemic or ocular allergies which might interfere with contact lens wear * Systemic disease which might interfere with contact lens wear * Ocular disease which might interfere with contact lens wear (e.g. hypoesthesia, insufficient lacrimal secretion) * Use of medication which might interfere with contact lens wear * Active ocular infection * Use of ocular medication * Significant ocular anomaly * Presence of two or more corneal scars in either eye * Pregnancy or lactation * Any medical condition that might be prejudicial to the study * Participated in any other clinical studies in the past month * Currently wears monovision
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Comfort | 1 week | Subjects rated study contact lens for overall comfort using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inferior Region Corneal Staining | 1 week | The investigator assessed abrasion to the lower portion of the cornea using the following scale:0 = None 1 = Slight micropunctate (1-10 spots) 2 = Moderate micropunctate (11-20 spots) 3 = Severe micropunctate (\>20 spots)4 = Slight macropunctate (1-5 spots) 5 = Moderate macropuntate (\>5-10 spots) 6 = Severe macropunctate (\>10 spots) 7 = Slight patch (1-2mm)8 = Moderate patch (\>2-4mm) 9 = Severe patch (\>4mm) |
| End of the Day Comfort | 1 week | Subjects rated study contact lens comfort at the end of a day of lens wear using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor. |
| Initial Comfort | 1 Week | Subjects rated study contact lens for comfort immediately when they first put the lenses on using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor. |
| Overall Lens Handling | 1 week | Subjects rated study contact lens for overall ease of handling using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Total Participants Total number of participants that completed the study. | 121 |
| Total | 121 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention | Lost to Follow-up | 1 | 0 |
| Second Intervention | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | Total Participants |
|---|---|
| Age, Continuous | 28.7 years STANDARD_DEVIATION 8.5 |
| Region of Enrollment United Kingdom | 121 participants |
| Sex: Female, Male Female | 80 Participants |
| Sex: Female, Male Male | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 122 | 0 / 122 |
| serious Total, serious adverse events | 0 / 122 | 0 / 122 |
Outcome results
Primary
Overall Comfort
Subjects rated study contact lens for overall comfort using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.
Time frame: 1 week
Population: Analysis includes all participants that completed the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Etafilcon A | Overall Comfort | 3.6685 units on a scale | Standard Error 0.1141 |
| Nelfilcon A | Overall Comfort | 3.4352 units on a scale | Standard Error 0.1148 |
Comparison: The alternative hypothesis is that etafilcon A contact lenses will have equal to ro higher ratings of overall comfort than nelfilcon A contact lenses.95% CI: [-0.03501, 0.2334]Mixed Models Analysis
Secondary
End of the Day Comfort
Subjects rated study contact lens comfort at the end of a day of lens wear using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.
Time frame: 1 week
Population: Analysis includes all participants that completed the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Etafilcon A | End of the Day Comfort | 3.148 units on a scale | Standard Error 0.127 |
| Nelfilcon A | End of the Day Comfort | 2.7479 units on a scale | Standard Error 0.1274 |
Comparison: The alternative hypothesis is that etafilcon A contact lenses have equal to or higher comfort ratings at the end of the day than nelfilcon A.98.7% CI: [-0.0055, 0.4001]Mixed Models Analysis
Secondary
Inferior Region Corneal Staining
The investigator assessed abrasion to the lower portion of the cornea using the following scale:0 = None 1 = Slight micropunctate (1-10 spots) 2 = Moderate micropunctate (11-20 spots) 3 = Severe micropunctate (\>20 spots)4 = Slight macropunctate (1-5 spots) 5 = Moderate macropuntate (\>5-10 spots) 6 = Severe macropunctate (\>10 spots) 7 = Slight patch (1-2mm)8 = Moderate patch (\>2-4mm) 9 = Severe patch (\>4mm)
Time frame: 1 week
Population: Analysis includes all participants that completed the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Etafilcon A | Inferior Region Corneal Staining | 0.7004 units on a scale | Standard Error 0.0643 |
| Nelfilcon A | Inferior Region Corneal Staining | 0.8085 units on a scale | Standard Error 0.0643 |
Comparison: The alternative hypothesis is that eyes that wore etafilcon A contact lenses will have less inferior region corneal staining than eyes that wore nelfilcon A contact lenses.98.7% CI: [-0.108, 0.06501]Mixed Models Analysis
Secondary
Initial Comfort
Subjects rated study contact lens for comfort immediately when they first put the lenses on using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.
Time frame: 1 Week
Population: Analysis includes all participants that completed the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Etafilcon A | Initial Comfort | 3.5694 units on a scale | Standard Error 0.1229 |
| Nelfilcon A | Initial Comfort | 3.6783 units on a scale | Standard Error 0.1233 |
Comparison: The alternative hypothesis is that etafilcon A contact lenses will have equal or higher ratings of initial comfort than nelfilcon A contact lenses.98.7% CI: [-0.5016, -0.1088]Mixed Models Analysis
Secondary
Overall Lens Handling
Subjects rated study contact lens for overall ease of handling using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.
Time frame: 1 week
Population: Analysis includes all participants that completed the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Etafilcon A | Overall Lens Handling | 3.546 units on a scale | Standard Error 0.1189 |
| Nelfilcon A | Overall Lens Handling | 3.2971 units on a scale | Standard Error 0.1187 |
Comparison: The alternative hypothesis is that etaflicon A contact lenses have equal to or higher ratings of ease of handling than nelfilcon A contact lenses.98.7% CI: [-0.1301, 0.2489]Mixed Models Analysis