Myopia
Conditions
Brief summary
This study seeks to evaluate and compare the clinical performance of two daily disposable soft contact lenses, Proclear 1 Day and 1-Day Acuvue Moist.
Interventions
DEVICEetafilcon A
1-day soft contact lens
DEVICEomafilcon A
1-day soft contact lens
Sponsors
Johnson & Johnson K.K. Medical Company
Visioncare Research Ltd.
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 39 Years
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age and no more than 39 years of age * Existing soft contact lens wearers * Willing to signed a written Informed Consent. * Own a mobile phone and are willing to receive and reply to Short Message Service (SMS) messages during the day. * Have a contact lens spherical distance requirement between -1.00 diopters (D) and -6.00 diopters (D) in both eyes. * Have an Astigmatism of 1.00D or less in both eyes. * Require a visual correction in both eyes. * Be correctable to a visual acuity of 6/9 (20/30) or better in each eye. * Have normal eyes with no evidence of abnormality or disease that would preclude lens wear.
Exclusion criteria
* Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, tarsal abnormalities, bulbar infection, or any other abnormality of the cornea that would contraindicate contact lens wear. * Clinically significant corneal staining (Grade 3 in more than one region). * Keratoconus or other corneal irregularity. * Abnormal lachrymal secretions. * Extended wear of contact lenses last 3 months. * Polymethyl methacrylate (PMMA) or rigid gas-permeable (RGP) lens wear in the previous 8 weeks. * Refractive surgery. * Eye injury/surgery within 8 weeks immediately prior to enrollment for this study. * Pre-existing ocular irritation that would preclude contact lens fitting. * Require concurrent ocular medication * Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear. * Any infectious disease (e.g., hepatitis, tuberculosis) or any immunosuppressive disease (e.g., HIV). * Diabetes. * Pregnant, lactating or planning a pregnancy at the time of enrollment. * Participation in any concurrent clinical trial or in last 30 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Rating of Comfort | after 1 week of lens wear | This outcome is a weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response. |
| Vision Quality | after 1 week of lens wear | This outcome is a weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response. |
| Subjective Rating of Handling | after 1 week of lens wear | This outcome is a weighted combined score calculated from individual lens handling-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response. |
| Corneal Staining | after 1 week of lens wear | Investigator assessment of the corneal staining. Staining is an indication of dryness on areas on the cornea. Here it is measured over 5 regions of the cornea: central, temporal, nasal, inferior, and superior. The staining is graded using the National Eye Institute (NEI)0-3 scale: grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe. |
| Subjective Rating of Quality Perceptions | after 1 week of lens wear | This outcome is a weighted combined score calculated from individual quality perception-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response. |
| Limbal Hyperemia | after 1 week of wear | This outcome is assessed by the investigator during biomicroscopy examination using the following 0-4 scale: 0 = none, 1 = trace, 2 = mild, 3= moderate, 4 = severe. |
Countries
Singapore
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Total Number of Participants This represents all subjects that completed the study minus one additional subject excluded due the discovery after study completion that the subject conflicted with exclusion criteria. | 113 |
| Total | 113 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention | exclusion criteria | 1 | 1 |
| Second Intervention | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Total Number of Participants |
|---|---|
| Age, Continuous | 25.3 years STANDARD_DEVIATION 4.4 |
| Region of Enrollment Singapore | 113 participants |
| Sex: Female, Male Female | 80 Participants |
| Sex: Female, Male Male | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 116 | 0 / 116 |
| serious Total, serious adverse events | 0 / 116 | 0 / 116 |
Outcome results
Primary
Corneal Staining
Investigator assessment of the corneal staining. Staining is an indication of dryness on areas on the cornea. Here it is measured over 5 regions of the cornea: central, temporal, nasal, inferior, and superior. The staining is graded using the National Eye Institute (NEI)0-3 scale: grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe.
Time frame: after 1 week of lens wear
Population: The analysis population represents subjects that completed the study per protocol.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Etafilcon A | Corneal Staining | 0.07 Units on a scale | Standard Error 0.01 |
| Omafilcon A | Corneal Staining | 0.09 Units on a scale | Standard Error 0.01 |
Comparison: The alternative hypothesis was that etafilcon A would be equivalent to omafilcon A for corneal staining.95% CI: [-0.03, 0.01]Mixed Models Analysis
Primary
Limbal Hyperemia
This outcome is assessed by the investigator during biomicroscopy examination using the following 0-4 scale: 0 = none, 1 = trace, 2 = mild, 3= moderate, 4 = severe.
Time frame: after 1 week of wear
Population: The analysis population represents subjects that completed the study per protocol.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Etafilcon A | Limbal Hyperemia | 0.51 Units on a scale | Standard Error 0.02 |
| Omafilcon A | Limbal Hyperemia | 0.48 Units on a scale | Standard Error 0.02 |
Comparison: The alternative hypothesis was that etafilcon A would be equivalent to omafilcon A from limbal hyperemia.95% CI: [-0.01, 0.06]Mixed Models Analysis
Primary
Subjective Rating of Comfort
This outcome is a weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.
Time frame: after 1 week of lens wear
Population: The analysis population represents subjects that completed the study per protocol.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Etafilcon A | Subjective Rating of Comfort | 3.33 Units on a scale | Standard Error 0.09 |
| Omafilcon A | Subjective Rating of Comfort | 3.32 Units on a scale | Standard Error 0.09 |
Comparison: The alternative hypothesis was that etafilcon A would be superior to omafilcon A for comfort.95% CI: [-0.21, 0.23]Mixed Models Analysis
Primary
Subjective Rating of Handling
This outcome is a weighted combined score calculated from individual lens handling-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.
Time frame: after 1 week of lens wear
Population: The analysis population represents subjects that completed the study per protocol.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Etafilcon A | Subjective Rating of Handling | 3.48 Units on a scale | Standard Error 0.09 |
| Omafilcon A | Subjective Rating of Handling | 3.48 Units on a scale | Standard Error 0.09 |
Comparison: The alternative hypothesis was that etafilcon A would be non-inferior to omafilcon A for lens handling.95% CI: [-0.22, 0.22]
Primary
Subjective Rating of Quality Perceptions
This outcome is a weighted combined score calculated from individual quality perception-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.
Time frame: after 1 week of lens wear
Population: The analysis population represents subjects that completed the study per protocol.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Etafilcon A | Subjective Rating of Quality Perceptions | 3.51 Units on a scale | Standard Error 0.08 |
| Omafilcon A | Subjective Rating of Quality Perceptions | 3.44 Units on a scale | Standard Error 0.08 |
Comparison: The alternative hypothesis was that etafilcon A would be non-inferior to omafilcon A for quality perceptions.95% CI: [-0.15, 0.29]Mixed Models Analysis
Primary
Vision Quality
This outcome is a weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.
Time frame: after 1 week of lens wear
Population: The analysis population represents subjects that completed the study per protocol.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Etafilcon A | Vision Quality | 3.53 Units on a scale | Standard Error 0.08 |
| Omafilcon A | Vision Quality | 3.50 Units on a scale | Standard Error 0.08 |
Comparison: The alternative hypothesis was that etafilcon A would be non-inferior to omafilcon A for vision.95% CI: [-0.19, 0.25]Mixed Models Analysis