Vision Correction
Conditions
Keywords
toric contact lenses, vision, comfort, toric fit characteristics, slit lamp findings
Brief summary
Evaluation of the clinical performance of two toric contact lenses in a 2-week, single masked (subject), daily wear, randomized, bilateral, parallel group study.
Interventions
DEVICEsenofilcon A toric
silicone hydrogel toric lens, worn daily for 2 wks (2wks replacement)
DEVICEbalafilcon A toric
silicone hydrogel toric lens, worn daily for 2 wks (2wks replacement)
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Be between 18 and 45 years of age. * Sign Written Informed Consent (See separate document). * Be an existing successful daily wear toric soft contact lens. * Require a visual correction in both eyes (monovision or uniocular fitting is NOT allowed). * Does not require presbyopic correction (can read J1 @ normal reading distance). * Have a sphere requirement in the range -1.00 and -5.00D (-5.25D refractive) * Have refractive astigmatism between 0.75D and 2.50D in both eyes. * Achieve visual acuity of 20/30 or better in each eye with spherical distance correction. * 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. stromal edema, vascularisation, infiltrates or abnormal opacities). * No other active ocular disease.
Exclusion criteria
* Requires concurrent ocular medication. * Clinically significant (Grade 3 or 4) corneal stromal haze, corneal vascularisation, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear. * Corneal staining Grade 3 in more than one region. * Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrolment for this study. * Abnormal lacrimal secretions. * Pre-existing ocular irritation that would preclude contact lens fitting. * Keratoconus or other corneal irregularity. * Polymethyl methacrylate (PMMA) or Rigid Gas Permeable (RGP) lens wear in the previous 8 weeks * Extended lens wear in last 3 months. * Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear. * Diabetic. * Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV). * Pregnancy, lactating or planning a pregnancy at the time of enrolment. * Participation in any concurrent clinical trial or in last 60 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lens Orientation | 1 minute after insertion | Proportion of eyes with lens orientation within 5 degrees of optimal |
| Lens Stability | 10-15 minutes after insertion | Lens stability is measured as the amount of rotation induced from blink after the lens has settled. |
| Subjective Comfort | 2 weeks of lens wear | Subjective comfort was derived from a weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response. \>0 = comfortable, \< 0 = uncomfortable. Combined measures from Week 1 and Week 5. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Fit Lens | after lens insertion | Time required for the optometrist to fit the lens. |
| Subjective Lens Vision | measured at 1 and 2 weeks | A weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response was used to derive vision outcomes. \>0 = satisfactory vision, \< 0 = unsatisfactory vision. Analysis is performed on combined 1 week and 2 week data. |
| Overall Corneal Staining | After 2 weeks use | National Eye Institute 0-3 Scale: Grade 0 = Normal, Grade 1 = Mild, superficial stippling, Grade 2 = Moderate, punctuate staining including superficial abrasion of the cornea, Grade 3 = Severe, abrasion or corneal erosion, deep corneal abrasion or recurrent erosion. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Senofilcon A Toric senofilcon A toric contact lens. Analysis includes participants that completed the study. | 137 |
| Balafilcon A Toric balafilcon A toric contact lens. Analysis includes participants that completed the study. | 139 |
| Total | 276 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | lens issue | 1 | 3 |
| Overall Study | Lost to Follow-up | 3 | 2 |
Baseline characteristics
| Characteristic | Senofilcon A Toric | Balafilcon A Toric | Total |
|---|---|---|---|
| Age, Continuous | 29.81 years STANDARD_DEVIATION 6.99 | 30.13 years STANDARD_DEVIATION 7.69 | 29.97 years STANDARD_DEVIATION 7.33 |
| Gender Female | 91 participants | 92 participants | 183 participants |
| Gender Male | 46 participants | 45 participants | 91 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 133 | 0 / 133 |
| serious Total, serious adverse events | 0 / 133 | 0 / 133 |
Outcome results
Primary
Lens Orientation
Proportion of eyes with lens orientation within 5 degrees of optimal
Time frame: 1 minute after insertion
Population: Analysis was performed on participants who completed the study per protocol. The data represents 274 eyes that wore senofilcon A lenses and 278 eyes that wore balafilcon A lenses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Senofilcon A Toric | Lens Orientation | 0.77 proportion of eyes |
| Balafilcon A Toric | Lens Orientation | 0.66 proportion of eyes |
Comparison: Alternative hypothesis is senofilcon A toric is superior to balfilcon A toric by having less degrees of rotation97.4% CI: [1.136, 1.739]Generalized Linear Model
Primary
Lens Stability
Lens stability is measured as the amount of rotation induced from blink after the lens has settled.
Time frame: 10-15 minutes after insertion
Population: Analysis was performed on participants who completed the study per protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Senofilcon A Toric | Lens Stability | 0.89 proportion of eyes |
| Balafilcon A Toric | Lens Stability | 0.88 proportion of eyes |
Comparison: Alternative hypothesis is that senofilcon A toric is superior to balafilcon A toric by having less degrees of instability.97.4% CI: [0.624, 1.138]Generalized Linear Model
Primary
Subjective Comfort
Subjective comfort was derived from a weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response. \>0 = comfortable, \< 0 = uncomfortable. Combined measures from Week 1 and Week 5.
Time frame: 2 weeks of lens wear
Population: Analysis was performed on participants who completed the study per protocol.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A Toric | Subjective Comfort | 0.1942 units on a scale | Standard Error 0.09637 |
| Balafilcon A Toric | Subjective Comfort | -0.1738 units on a scale | Standard Error 0.09716 |
Comparison: Alternative hypothesis is that senofilcon A toric is superior to balafilcon A toric.97.4% CI: [0.07001, 0.368]Mixed Models Analysis
Secondary
Overall Corneal Staining
National Eye Institute 0-3 Scale: Grade 0 = Normal, Grade 1 = Mild, superficial stippling, Grade 2 = Moderate, punctuate staining including superficial abrasion of the cornea, Grade 3 = Severe, abrasion or corneal erosion, deep corneal abrasion or recurrent erosion.
Time frame: After 2 weeks use
Population: Analysis was performed on participants who completed the study per protocol.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A Toric | Overall Corneal Staining | 0.0919 units on a scale | Standard Error 0.0178 |
| Balafilcon A Toric | Overall Corneal Staining | 0.1607 units on a scale | Standard Error 0.0178 |
Comparison: Alternative hypothesis is that senofilcon A toric is superior to balafilcon A toric by having a lower grade fo corneal staining.97.5% CI: [-0.0688, -0.0197]Mixed Models Analysis
Secondary
Subjective Lens Vision
A weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response was used to derive vision outcomes. \>0 = satisfactory vision, \< 0 = unsatisfactory vision. Analysis is performed on combined 1 week and 2 week data.
Time frame: measured at 1 and 2 weeks
Population: Analysis was performed on participants who completed the study per protocol.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A Toric | Subjective Lens Vision | 0.1942 units on a scale | Standard Error 0.09637 |
| Balafilcon A Toric | Subjective Lens Vision | -0.1738 units on a scale | Standard Error 0.09716 |
Comparison: Alternative hypothesis is that senofilcon A is superior to balafilcon A.97.4% CI: [0.07001, 0.368]Mixed Models Analysis
Secondary
Time to Fit Lens
Time required for the optometrist to fit the lens.
Time frame: after lens insertion
Population: Analysis was performed on participants who completed the study per protocol.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A Toric | Time to Fit Lens | 6.2789 minutes | Standard Error 0.2045 |
| Balafilcon A Toric | Time to Fit Lens | 7.4095 minutes | Standard Error 0.1994 |
Comparison: Alternative hypothesis is that senofilcon A toric is superior to balafilcon A toric by having less time required to fit.97.5% CI: [-1.1307, -0.568]Mixed Models Analysis