Astigmatism
Conditions
Brief summary
To evaluate two toric contact lenses on the ocular physiology of existing contact lens wearers when used in an extended wear modality of days/six nights.
Interventions
soft contact lens
DEVICEbalafilcon A toric contact lens
soft contact lens
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Able to wear study lenses in parameters available * Non-presbyopes between the ages of 18-45 * Understand and sign informed consent * Willing to follow the protocol * Achieve at least 20/30 (6/9) visual acuity (VA) in right eye (OD) and left eye (OS) with study lenses * Myopia -0.75 to -6.25, cylinder -0.75 to -1.50 diopters (D) (axis 90 +/- 15, 180 +/- 15) or -1.75 D (axis 90 +/- 10, 180 +/- 10) * Adapted soft contact lens wearer * Swims no more than once a week * Has a wearable pair of spectacles.
Exclusion criteria
* Any ocular or systemic disorder which may contraindicate contact lens wear * Any topical ocular medication * Aphakic * Corneal refractive surgery * Corneal distortion from hard CL wear or keratoconus * Pregnant or lactating * Grade 2 or worse slit lamp signs * Infectious disease * Previous clinical study within 2 weeks * Don't agree to participate * Polymethyl methacrylate (PMMA) or rigid gas-permeable (RGP) lens wear in last 8 weeks * Previous adverse effects that contraindicate extended lens wear. * Self-reported symptoms of itchiness or scratchiness with habitual lenses.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corneal Staining | at 3 months of lens wear (period 1) | Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally. |
| Limbal Redness | at 3 months of lens wear (period 1) | Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally. |
| Bulbar Redness | at 3 months of lens wear (period 1) | Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally. |
| Tarsal Roughness | at 3 months of lens wear (period 1) | Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally. |
Countries
Australia, United States
Participant flow
Recruitment details
Recruitment occurred at 1 site in the USA (n=50 enrolled), and 7 sites in Australia (n=62 enrolled)
Pre-assignment details
Total of 112 subjects enrolled, 77 subjects completed study after 3 months. The study was then restricted down to two sites (Australia only) after 3 months with only 37 of the 77 being included. There were 36 subjects whom completed the full 6 month trial period.
Participants by arm
| Arm | Count |
|---|---|
| Senofilcon A Toric Bilaterally senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. | 36 |
| Balafilcon A Toric Bilaterally balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. | 25 |
| Senofilcon A/Balafilcon A Contralaterally senofilcon A lens worn in one eye and balafilcon A lens worn in the other eye (contralaterally), daily for 3 months, replaced weekly. | 51 |
| Total | 112 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Baseline to Month 3 (Period 1) | Adverse Event | 4 | 3 | 6 |
| Baseline to Month 3 (Period 1) | Lost to Follow-up | 6 | 3 | 13 |
| Month 3 to Month 6 (Period 2) | Pregnancy | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Senofilcon A Toric Bilaterally | Balafilcon A Toric Bilaterally | Senofilcon A/Balafilcon A Contralaterally | Total |
|---|---|---|---|---|
| Age, Continuous | 29.8 years STANDARD_DEVIATION 6.9 | 30.4 years STANDARD_DEVIATION 7.8 | 29.6 years STANDARD_DEVIATION 8.6 | 29.8 years STANDARD_DEVIATION 7.9 |
| Region of Enrollment Australia | 20 participants | 14 participants | 31 participants | 65 participants |
| Region of Enrollment United States | 16 participants | 11 participants | 20 participants | 47 participants |
| Sex: Female, Male Female | 25 Participants | 19 Participants | 35 Participants | 79 Participants |
| Sex: Female, Male Male | 11 Participants | 6 Participants | 16 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 13 / 87 | 9 / 76 |
| serious Total, serious adverse events | 0 / 87 | 1 / 76 |
Outcome results
Primary
Bulbar Redness
Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.
Time frame: at 3 months of lens wear (period 1)
Population: Subjects analyzed included those who were enrolled, randomized to a study arm, and completed the study at 3 months, (n=77). Subjects were analyzed by device therefore the subjects from the contralateral arm were counted once in EITHER of the device arms for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Bulbar Redness | 0.9 units on a scale | Standard Deviation 0.58 |
| Balafilcon A | Bulbar Redness | 0.8 units on a scale | Standard Deviation 0.57 |
Primary
Corneal Staining
Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.
Time frame: at 3 months of lens wear (period 1)
Population: Subjects analyzed included those who were enrolled, randomized to a study arm, and completed the study at 3 months, (n=77). Subjects were analyzed by device therefore the subjects from the contralateral arm were counted once in EITHER of the device arms for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Corneal Staining | 0.6 units on a scale | Standard Deviation 0.61 |
| Balafilcon A | Corneal Staining | 0.8 units on a scale | Standard Deviation 0.74 |
Primary
Limbal Redness
Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.
Time frame: at 3 months of lens wear (period 1)
Population: Subjects analyzed included those who were enrolled, randomized to a study arm, and completed the study at 3 months, (n=77). Subjects were analyzed by device therefore the subjects from the contralateral arm were counted once in EITHER of the device arms for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Limbal Redness | 0.7 units on a scale | Standard Deviation 0.61 |
| Balafilcon A | Limbal Redness | 0.7 units on a scale | Standard Deviation 0.58 |
Primary
Tarsal Roughness
Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.
Time frame: at 3 months of lens wear (period 1)
Population: Subjects analyzed included those who were enrolled, randomized to a study arm, and completed the study at 3 months, (n=77). Subjects were analyzed by device therefore the subjects from the contralateral arm were counted once in EITHER of the device arms for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Tarsal Roughness | 1.1 units on a scale | Standard Deviation 0.58 |
| Balafilcon A | Tarsal Roughness | 1.0 units on a scale | Standard Deviation 0.75 |