Refractive Error
Conditions
Brief summary
This study seeks to evaluate the clinical performance of two daily disposable contact lenses.
Interventions
DEVICEetafilcon A
daily disposable contact lens
DEVICEocufilcon D
daily disposable contact lens
Sponsors
Singapore Polytechnic University
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
21 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* Be between 21 and 39 years of age. * Signed Written Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space. * Be existing (i.e. successfully worn for 1-month prior to the study) soft contact lens wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed). * Require a visual correction in both eyes (monovision allowed but no monofit). * Have a contact lens spherical distance requirement between -1.00D and -6.00D in both eyes. * Astigmatism of 1.00D or less in both eyes. * Be able to wear the lens powers available for this study. * Be correctable to a visual acuity of 20/30 or better in each eye. * Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: * No amblyopia. * No evidence of lid abnormality or infection. * No conjunctival abnormality or infection. * No clinically significant slit lamp findings (i.e. edema, staining, scarring, vascularisation, infiltrates or abnormal opacities). * No other active ocular disease.
Exclusion criteria
* Requires concurrent ocular medication. * Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear. * Clinically significant (Grade 3 or 4) corneal edema, corneal vascularisation, corneal staining, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear. * Diabetic. * Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV). * Extended lens wear in last 3 months. * PMMA or RGP lens wear in the previous 8 weeks. * Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrollment for this study. * Abnormal lacrimal secretions. * Pre-existing ocular irritation that would preclude contact lens fitting. * Keratoconus or other corneal irregularity. * Pregnancy, lactating or planning a pregnancy at the time of enrollment. * Participation in any concurrent clinical trial or in last 60 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lens Comfort | 1-week follow-up | Lens comfort was evaluated via the subjective question: How comfortable did your eyes feel at the end of the day when wearing the contact lenses you were provided? (excellent/very good=5...very good=3...Poor=0) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comfort Throughout the Whole Day | 1-week follow-up | Comfort throughout the day was evaluated via subjective question: Comfort throughout the whole day and is reported as an aggregate of Agree Strongly and Agree Somewhat. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Comfort While Working on Computer | 1-week-follow-up | Comfort throughout the day was evaluated via subjective question: Comfort while working on computer and is reported as an aggregate of Agree Strongly and Agree Somewhat. |
Countries
Singapore
Participant flow
Recruitment details
There were 50 subjects enrolled in this single site study, located at Singapore University.
Pre-assignment details
There were 50 patients enrolled and randomized, and 50 patients completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Overall Total number of completed participants are included in baseline measurements. | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 25.0 years STANDARD_DEVIATION 4.8 |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 19 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 / 12 | 0 / 13 | 0 / 13 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 13 | 0 / 13 | 0 / 12 |
Outcome results
Primary
Lens Comfort
Lens comfort was evaluated via the subjective question: How comfortable did your eyes feel at the end of the day when wearing the contact lenses you were provided? (excellent/very good=5...very good=3...Poor=0)
Time frame: 1-week follow-up
Population: Subjects analyzed were those who were enrolled, randomized, and completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etafilcon A | Lens Comfort | 3.08 units on a scale | Standard Deviation 0.98 |
| Ocufilcon D | Lens Comfort | 3.00 units on a scale | Standard Deviation 1.15 |
Secondary
Comfort Throughout the Whole Day
Comfort throughout the day was evaluated via subjective question: Comfort throughout the whole day and is reported as an aggregate of Agree Strongly and Agree Somewhat.
Time frame: 1-week follow-up
Population: Subjects analyzed were those enrolled, randomized, and completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etafilcon A | Comfort Throughout the Whole Day | 39.2 percentage of participants |
| Ocufilcon D | Comfort Throughout the Whole Day | 36.7 percentage of participants |
Other Pre-specified
Comfort While Working on Computer
Comfort throughout the day was evaluated via subjective question: Comfort while working on computer and is reported as an aggregate of Agree Strongly and Agree Somewhat.
Time frame: 1-week-follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etafilcon A | Comfort While Working on Computer | 47.0 percentage of participants |
| Ocufilcon D | Comfort While Working on Computer | 42.9 percentage of participants |