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
DEVICEomafilcon A
contact lens
Sponsors
Eurolens Research
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 No maximum
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 which have 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 worn soft 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 edema, corneal vascularization, 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 are currently taking part in any other clinical study or research.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance Visual Acuity | 1 week | logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lens Comfort | 1 week | A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control.\>0 = comfortable, \<0 = uncomfortable |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Entire Population | 65 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Period One | Adverse Event | 0 | 0 | 1 | 0 |
| Period One | ineligible | 0 | 0 | 1 | 1 |
| Period One | Protocol Violation | 0 | 0 | 1 | 0 |
| Period One | Withdrawal by Subject | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Entire Population |
|---|---|
| Age, Continuous | 28.9 years STANDARD_DEVIATION 5.3 |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 24 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 / 15 | 0 / 10 | 0 / 17 | 0 / 17 |
| serious Total, serious adverse events | 0 / 15 | 0 / 10 | 0 / 17 | 0 / 17 |
Outcome results
Primary
Distance Visual Acuity
logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
Time frame: 1 week
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Etafilcon A | Distance Visual Acuity | 0.03460 logMar | Standard Error 0.007129 |
| Omafilcon A | Distance Visual Acuity | 0.02931 logMar | Standard Error 0.006666 |
Comparison: Null Hypothesis: etafilcon A is greater than or equal to omafilcon A.95% CI: [-0.01389, 0.2447]Mixed Models Analysis
Secondary
Lens Comfort
A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control.\>0 = comfortable, \<0 = uncomfortable
Time frame: 1 week
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Etafilcon A | Lens Comfort | 0.3113 Units on a scale | Standard Error 0.1765 |
| Omafilcon A | Lens Comfort | -0.1645 Units on a scale | Standard Error 0.2075 |
95% CI: [0.05563, 0.4757]Mixed Models Analysis