Astigmatism, Myopia
Conditions
Brief summary
Primary Hypotheses: Senofilcon A will provide significantly less rotation with subjects in a recumbent position than Filcon II 3 monthly . Etafilcon A will provide significantly less rotation with subjects in a recumbent position than Filcon II 3 1 1 day . Etafilcon A will provide rotation with subjects a recumbent position non-inferior to nelfilcon A. A margin of 5 degrees will be used. Secondary Hypotheses: Senofilcon A will have significantly better monocular visual performance with subjects in a recumbent position than Filcon II 3 monthly. Etafilcon A for astigmatism will have significantly better monocular visual performance with subjects in a recumbent position than Filcon II 3 1 day. Etafilcon A will have monocular visual performance with subjects in a recumbent position non-inferior nelfilcon A. A margin of 0.05 LogMAR will be used.
Interventions
DEVICEsenofilcon A
bilateral daily use soft contact lens
DEVICEetafilcon A
bilateral daily use soft contact lens
DEVICEnelfilcon A
bilateral daily use soft contact lens
DEVICEFilcon II 3
bilateral daily use soft contact lens
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 55 Years
Healthy volunteers
No
Inclusion criteria
* Age range 18-60 years. * Read, understand, and sign written Statement of Informed Consent. * Appear able and willing to adhere to the instructions set forth in the 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 -1.00 to -6.00D. * Have astigmatism of between -0.75 and -2.00DC in both eyes. * Have axes of astigmatism within +/-10° of the following available lens axes: 70°, 90°, 110°, 20°, 180° & 160°, i.e. 60-120, 10-30 and 150-180. * Monocular distance visual acuity correctable to 6/9 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: i) Clear cornea ii) No anterior segment disorder iii) No clinically significant slit lamp findings (i.e. edema, staining, scarring, vascularization, infiltrates or abnormal opacities) iv) No other active ocular disease or recent surgery
Exclusion criteria
* Having worn rigid gas permeable (RGP) contact lenses within the last 30 days or polymethyl methacrylate (PMMA) contact lenses within the last 3 months. * Clinically significant corneal edema, corneal vascularization, 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 |
|---|---|---|
| Lens Orientation in Recumbent Position | up to 60 minutes in recumbent position | rotation from zero position also described as absolute value of the rotation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Monocular Visual Acuity in Recumbent Position | up to 60 minutes in recumbent position | Visual Acuity measured in LogMAR units. High contrast visual acuity (VA) was measured in both eyes using a 3m LogMAR test chart at 2.5m testing distance (subsequently converted). |
Countries
United Kingdom
Participant flow
Recruitment details
Subjects were recruited and screened based on the inclusion/exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Overall Subjects All subjects who were enrolled, and completed the study. | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | Overall Subjects |
|---|---|
| Age, Continuous | 43.2 years STANDARD_DEVIATION 15.3 |
| Region of Enrollment United Kingdom | 24 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 24 | 0 / 24 | 0 / 24 | 0 / 24 | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 | 0 / 24 | 0 / 24 | 0 / 24 |
Outcome results
Primary
Lens Orientation in Recumbent Position
rotation from zero position also described as absolute value of the rotation.
Time frame: up to 60 minutes in recumbent position
Population: Subjects analyzed were those enrolled, randomized, and whom completed the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Senofilcon A (AOfA) | Lens Orientation in Recumbent Position | 15.8 degrees |
| Filcon II 3 (Sauflon) | Lens Orientation in Recumbent Position | 35.2 degrees |
| Etafilcon A (1DAMfA) | Lens Orientation in Recumbent Position | 19.4 degrees |
| Filcon II 3 (C1DT) | Lens Orientation in Recumbent Position | 29.1 degrees |
| Nelfilcon A (FDT) | Lens Orientation in Recumbent Position | 21.7 degrees |
Secondary
Monocular Visual Acuity in Recumbent Position
Visual Acuity measured in LogMAR units. High contrast visual acuity (VA) was measured in both eyes using a 3m LogMAR test chart at 2.5m testing distance (subsequently converted).
Time frame: up to 60 minutes in recumbent position
Population: Analysis is on those who were enrolled, randomized, and whom completed the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Senofilcon A (AOfA) | Monocular Visual Acuity in Recumbent Position | -0.008 units on a scale (LogMAR) |
| Filcon II 3 (Sauflon) | Monocular Visual Acuity in Recumbent Position | 0.041 units on a scale (LogMAR) |
| Etafilcon A (1DAMfA) | Monocular Visual Acuity in Recumbent Position | 0.024 units on a scale (LogMAR) |
| Filcon II 3 (C1DT) | Monocular Visual Acuity in Recumbent Position | 0.081 units on a scale (LogMAR) |
| Nelfilcon A (FDT) | Monocular Visual Acuity in Recumbent Position | -0.013 units on a scale (LogMAR) |