Refractive Error, Myopia
Conditions
Brief summary
This study seeks to evaluate the clinical fitting performance of a new daily disposable contact lens to an existing daily disposable contact lens.
Interventions
DEVICEetafilcon A
contact lens
DEVICEnarafilcon A
contact lens
Sponsors
Visioncare Research Ltd.
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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 |
|---|---|---|
| Proportion of Eyes Successfully Fit | Within 20 minutes of lens insertion | Overall lens fit acceptance was assessed by the Investigator based on lens fit alone in a 6-level scale; 0=should not be worn, 1=should not be dispensed although no immediate danger, 2=borderline but unacceptable, 3=minimal acceptable, early review, 4=not perfect but OK to dispense and 5=perfect. Lens fitting responses \>2 were considered 'successful fit' while the rest of responses were considered 'unsuccessful fit'. |
| Lens Fit Decentration | Within 20 minutes of lens insertion | Lens centration was assessed in primary gaze, diffuse white light, low-medium magnification, with graticule. Lens fit decentration with respect to visible cornea was measured to nearest 0.1mm. |
| Lens Tightness on Cornea With Manual Digit Push Up | Within 20 minutes of lens insertion | Lens tightness on push-up assessed by digital push-up test (gentle push of the lens upward using the lower lid) with eye in primary gaze position and observing ease of push-up and speed of return to original position. Tightness is measured on a 0%-100% continuous scale where 0%=falls from cornea without lid support, 50%=optimum and 100%=no movement. |
Countries
United Kingdom
Participant flow
Recruitment details
There were 25 subjects enrolled to the study.
Pre-assignment details
Subjects were enrolled per inclusion/exclusion criteria and randomized to a study arm.
Participants by arm
| Arm | Count |
|---|---|
| All Subjects All subjects who enrolled and completed study. | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Continuous | 44.9 years STANDARD_DEVIATION 11.9 |
| Region of Enrollment United Kingdom | 25 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 8 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 / 6 | 0 / 7 | 0 / 4 | 0 / 2 |
| serious Total, serious adverse events | 0 / 6 | 0 / 7 | 0 / 4 | 0 / 2 |
Outcome results
Primary
Lens Fit Decentration
Lens centration was assessed in primary gaze, diffuse white light, low-medium magnification, with graticule. Lens fit decentration with respect to visible cornea was measured to nearest 0.1mm.
Time frame: Within 20 minutes of lens insertion
Population: Participants who were enrolled and completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Narafilcon A (Bilateral) | Lens Fit Decentration | 0.25 mm | Standard Deviation 0.14 |
| Narafilcon A (Contralateral) | Lens Fit Decentration | 0.22 mm | Standard Deviation 0.16 |
| Etafilcon A (Bilateral) | Lens Fit Decentration | 0.27 mm | Standard Deviation 0.17 |
| Etafilcon A (Contralateral) | Lens Fit Decentration | 0.27 mm | Standard Deviation 0.15 |
Primary
Lens Tightness on Cornea With Manual Digit Push Up
Lens tightness on push-up assessed by digital push-up test (gentle push of the lens upward using the lower lid) with eye in primary gaze position and observing ease of push-up and speed of return to original position. Tightness is measured on a 0%-100% continuous scale where 0%=falls from cornea without lid support, 50%=optimum and 100%=no movement.
Time frame: Within 20 minutes of lens insertion
Population: Participants who were enrolled and completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Narafilcon A (Bilateral) | Lens Tightness on Cornea With Manual Digit Push Up | 44.6 percentage | Standard Deviation 6.3 |
| Narafilcon A (Contralateral) | Lens Tightness on Cornea With Manual Digit Push Up | 46.9 percentage | Standard Deviation 5.5 |
| Etafilcon A (Bilateral) | Lens Tightness on Cornea With Manual Digit Push Up | 56.3 percentage | Standard Deviation 8.6 |
| Etafilcon A (Contralateral) | Lens Tightness on Cornea With Manual Digit Push Up | 58.1 percentage | Standard Deviation 7.8 |
Primary
Proportion of Eyes Successfully Fit
Overall lens fit acceptance was assessed by the Investigator based on lens fit alone in a 6-level scale; 0=should not be worn, 1=should not be dispensed although no immediate danger, 2=borderline but unacceptable, 3=minimal acceptable, early review, 4=not perfect but OK to dispense and 5=perfect. Lens fitting responses \>2 were considered 'successful fit' while the rest of responses were considered 'unsuccessful fit'.
Time frame: Within 20 minutes of lens insertion
Population: Participants who were enrolled and completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Narafilcon A (Bilateral) | Proportion of Eyes Successfully Fit | 0.98 proportion of participant eyes |
| Narafilcon A (Contralateral) | Proportion of Eyes Successfully Fit | 0.96 proportion of participant eyes |
| Etafilcon A (Bilateral) | Proportion of Eyes Successfully Fit | 0.96 proportion of participant eyes |
| Etafilcon A (Contralateral) | Proportion of Eyes Successfully Fit | 0.96 proportion of participant eyes |