Astigmatism, Myopia
Conditions
Brief summary
This study is evaluating the initial fit of toric contact lenses.
Interventions
DEVICEetafilcon A
A daily wear contact lens
DEVICEnelfilcon A
A daily wear contact lens
DEVICEFilcon II 3
a daily disposable
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 No maximum
Healthy volunteers
No
Inclusion criteria
* Be greater than or equal to 18 years old. * Read, understand, and sign written Statement of Informed Consent. * Appear able and willing to adhere to the instructions set forth in this clinical protocol. * Be existing 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 spherical contact lens requirement in the range -0.50D to -6.00D. * Have astigmatism of between -0.50 and -2.00DC in both eyes. * Monocular distance visual acuity correctable to 6/9 (0.2 logMAR) or better in each eye with best sphero-cylindrical refraction. * Have normal eyes with no evidence of any ocular abnormality or disease. For the purposes of this study a normal eye is defined as one having: Clear cornea, No anterior segment disorder, No clinically significant slit lamp findings (i.e. oedema, staining, scarring, vascularisation, infiltrates or abnormal opacities), No other active ocular disease or recent surgery
Exclusion criteria
* Having worn RGP contact lenses within the last 30 days or PMMA contact lenses within the last 3 months. * Clinically significant corneal oedema, corneal vascularisation, corneal staining, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear. * Extended lens wear in last 3 months. * Any systemic or topical medications that will in the investigator's opinion affect ocular physiology or contact lens performance. * Any systemic disease affecting ocular health. * Abnormal lacrimal secretions. * Keratoconus or other corneal irregularity. * Pregnancy, lactating or planning a pregnancy at the time of enrolment. * Participation in any concurrent clinical trial. * Any previous anterior ocular surgery. * Subjects who are known to have an infectious systemic disease (e.g., hepatitis, tuberculosis). * Subjects who are known to have an immunosuppressive disease (e.g., HIV positive). * Subjects who are known to have diabetes. * Employees or family members of the Research site, Principal Investigator or study team.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase I: Absolute Lens Rotation | At 1-min after lens insertion during Phase I | At 1-min after lens insertion, lens orientation position was assessed on a scale of 0-180 degree on both eyes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase I: Time to Lens Settling | 5 minutes after lens insertion during Phase I | With random insertion and natural blinking, the slit lamp video was used to measure the time of lens settling. |
| Phase I: Number of Blinks Until Settled | Baseline to 5 minutes during Phase I | Number of blinks for the right eye was counted until lens settling using headcam video. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Phase II: Absolute Rotation | 1-minute during Phase II | Absolute rotation of the lens (degrees) at 1-minute post-fit on both eyes. Filcon II 3 lens was only used for comparison in phase II of the study per study protocol. |
Countries
United Kingdom
Participant flow
Recruitment details
Subjects are considered to be enrolled and not randomized at baseline. There were 42 subjects enrolled and 2 that were not randomized for a study baseline population of 40.
Participants by arm
| Arm | Count |
|---|---|
| All Subjects All subjects who were enrolled at baseline. | 42 |
| Total | 42 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Continuous | 51.45 years STANDARD_DEVIATION 12.707 |
| Region of Enrollment United Kingdom | 42 participants |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 | 0 / 40 |
Outcome results
Primary
Phase I: Absolute Lens Rotation
At 1-min after lens insertion, lens orientation position was assessed on a scale of 0-180 degree on both eyes.
Time frame: At 1-min after lens insertion during Phase I
Population: Subjects included in the analysis were those who were enrolled, randomized, and completed the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Etafilcon A | Phase I: Absolute Lens Rotation | 6.73 Degrees |
| Nelfilcon A | Phase I: Absolute Lens Rotation | 11.38 Degrees |
Primary
Phase I: Absolute Lens Rotation
Lens orientation position as assessed on a scale of 0-180 on both eyes.
Time frame: 3 min after lens insertion during Phase I
Population: Analysis was on those subjects who were enrolled, randomized, and completed the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Etafilcon A | Phase I: Absolute Lens Rotation | 6.26 Degrees |
| Nelfilcon A | Phase I: Absolute Lens Rotation | 11.06 Degrees |
Secondary
Phase I: Number of Blinks Until Settled
Number of blinks for the right eye was counted until lens settling using headcam video.
Time frame: Baseline to 5 minutes during Phase I
Population: Subjects analyzed are those who were enrolled, randomized, and completed the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Etafilcon A | Phase I: Number of Blinks Until Settled | 57.29 Blinks | Standard Error 6.65 |
| Nelfilcon A | Phase I: Number of Blinks Until Settled | 74.73 Blinks | Standard Error 4.56 |
Secondary
Phase I: Time to Lens Settling
With random insertion and natural blinking, the slit lamp video was used to measure the time of lens settling.
Time frame: 5 minutes after lens insertion during Phase I
Population: Subjects analyzed were those who were enrolled, randomized, and completed the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Etafilcon A | Phase I: Time to Lens Settling | 1.60 minutes |
| Nelfilcon A | Phase I: Time to Lens Settling | 1.82 minutes |
Other Pre-specified
Phase II: Absolute Rotation
Absolute rotation of the lens (degrees) at 1-minute post-fit on both eyes. Filcon II 3 lens was only used for comparison in phase II of the study per study protocol.
Time frame: 1-minute during Phase II
Population: Analysis was on those subjects who were enrolled, randomized, and completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etafilcon A | Phase II: Absolute Rotation | 9.99 Degrees | Standard Deviation 14.194 |
| Nelfilcon A | Phase II: Absolute Rotation | 17.54 Degrees | Standard Deviation 17.431 |
| Filcon II 3 | Phase II: Absolute Rotation | 16.59 Degrees | Standard Deviation 30.82 |