Astigmatism
Conditions
Keywords
astigmatism, visual acuity, fit, comfort, satisfaction, contact lens
Brief summary
The purpose of this study is to determine the relative performance of a new toric soft contact lens against a toric and a spherical contact lens currently available in market, specifically with regards to the fit and visual acuity as well as the comfort, vision and satisfaction while in the practitioner's office. Approximately 2 hours duration.
Detailed description
Non-dispensing, single-masked (subject-masked), randomised, controlled study.
Interventions
Sponsors
Foresight Regulatory Strategies, Inc.
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 39 Years
Healthy volunteers
No
Inclusion criteria
1. be at least 18 and less than or equal to 39 years of age and have a need for vision correction in BOTH eyes (monovision or uniocular fitting is NOT allowed). 2. be of Asian descent (Japanese, Chinese, Korean, Polynesian or other Asian ancestry) and have Asian Eye anatomy 3. have successfully worn toric or spherical soft (hydrogel or silicone hydrogel) contact lenses for at least 4-weeks prior to enrollment in the study. 4. be able and willing to adhere to the instructions set forth in the protocol. 5. agree to wear their contact lenses in both eyes on a daily wear schedule for at least 8 hours per day every day during the study. 6. have a distance spherical component between -1.00 D and -5.50 D with cylinder in the range of 0.75 D to 2.25 D and cylinder axis within 10 ° of the vertical and within 20 ° of the horizontal in both eyes 7. have a best corrected manifest refraction visual acuity of at least 20/25 or better in each eye. 8. be in good general health, based on his/her knowledge. 9. read, be given an explanation of, indicate understanding of, and sign the STATEMENT OF INFORMED CONSENT.
Exclusion criteria
1. The subject is a rigid gas permeable (RGP) or daily disposable soft lens wearer. 2. The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures. 3. The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (i.e., Sjögren's syndrome, type II diabetes, etc). 4. Slit lamp findings that would contraindicate contact lens wear such as: * Pathological dry eye or associated findings * Pterygium or corneal scars within the visual axis * Neovascularization \>1mm in from the limbus * History of giant papillary conjunctivitis (GPC) worse than Grade 2 * Anterior uveitis or iritis (past or present) * Seborrhoeic eczema, seborrhoeic conjunctivitis 5. A history of recurrent erosions, corneal infiltrates, corneal ulcer or fungal infections. 6. A known history of corneal hypoesthesia (reduced corneal sensitivity.) 7. Aphakia, keratoconus or a highly irregular cornea. 8. Current pregnancy or lactation (to the best of the subject's knowledge). 9. Active participation in another clinical study at any time during this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | 15-20 minutes | Number of eyes with Distance Visual Acuity 20/20 or better |
| Patient Reported Vision | 15-20 minutes | A weighted combined score calculated from individual confort-vision related questions asked on a 1-5 scale, 1=most negative resonse to 5=most positive response, was used to derive vision scores. The analysis shows the difference in outcome between test and control. \>0=greater vision, \<0=lesser vision. |
| Lens Orientation Within 5 Degrees | 1 minute | Meaures in what position does the lens sit on the eye at insertion and is measured in degrees of rotation. |
| Lens Stability Within 5 Degrees | 1 minute | Measures if the lens changes position on the eye as it is worn and is measured in degrees of rotation. |
| Patient Reported Comfort. | 15-20 minutes | 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, was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control. \>0=comfortable, \<0=uncomfortable |
| Patient Preference | end of study | This outcome measures which lens the subjects preferred to wear. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Completed Population Only participants that completed the study are included (n=88) | 88 |
| Total | 88 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| First Intervention | Discontinuation | 0 | 0 | 1 | 0 | 0 | 0 |
| Third Intervention | Protocol Violation | 0 | 0 | 1 | 0 | 4 | 2 |
Baseline characteristics
| Characteristic | Completed Population |
|---|---|
| Age, Continuous | 28.0 years STANDARD_DEVIATION 5.96 |
| Sex: Female, Male Female | 52 Participants |
| Sex: Female, Male Male | 36 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 | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 17 | 0 / 17 | 0 / 16 | 0 / 14 | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 | 0 / 16 | 0 / 14 | 0 / 16 | 0 / 16 |
Outcome results
Primary
Lens Orientation Within 5 Degrees
Meaures in what position does the lens sit on the eye at insertion and is measured in degrees of rotation.
Time frame: 1 minute
Population: Analysis includes participants who completed the study per protocol (n=88 subjects, 176 eyes)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Senofilcon A Toric | Lens Orientation Within 5 Degrees | 142 degrees |
| Alphafilcon A Toric | Lens Orientation Within 5 Degrees | 126 degrees |
Comparison: Aletrnative hypothesis was senofilcon A toric was superior to alphafilcon A toric by having more eyes within 5 degrees.p-value: 0.2161Chi-squared
Primary
Lens Stability Within 5 Degrees
Measures if the lens changes position on the eye as it is worn and is measured in degrees of rotation.
Time frame: 1 minute
Population: Analysis includes participants who completed the study per protocol (n=88 subjects, 176 eyes)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Senofilcon A Toric | Lens Stability Within 5 Degrees | 156 degrees |
| Alphafilcon A Toric | Lens Stability Within 5 Degrees | 140 degrees |
Comparison: Alternative hypothesis was senofilcon A toric was superior to alphafilcon A toric by having more eyes within 5 degreesp-value: 0.1328Chi-squared
Primary
Patient Preference
This outcome measures which lens the subjects preferred to wear.
Time frame: end of study
Population: Analysis includes participants who completed the study per protocol (n=88)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Senofilcon A Toric | Patient Preference | 62 Number of participants |
| Alphafilcon A Toric | Patient Preference | 5 Number of participants |
| Etafilcon A Sphere | Patient Preference | 18 Number of participants |
Comparison: Alternative hypothesis was senofilcon A toric was superior to etafilcon A sphere.p-value: <0.0001Chi-squared
Primary
Patient Reported Comfort.
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, was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control. \>0=comfortable, \<0=uncomfortable
Time frame: 15-20 minutes
Population: Analysis includes participants who completed the study per protocol (n=88)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A Toric | Patient Reported Comfort. | 0.1425 Scores on a scale | Standard Error 0.1034 |
| Alphafilcon A Toric | Patient Reported Comfort. | -0.3464 Scores on a scale | Standard Error 0.1035 |
| Etafilcon A Sphere | Patient Reported Comfort. | 0.2176 Scores on a scale | Standard Error 0.1028 |
Comparison: Alternative hypothesis was senofilcon A toric was superior to alphafilcon A toric.95% CI: [0.1529, 0.489]Mixed Models Analysis
Primary
Patient Reported Vision
A weighted combined score calculated from individual confort-vision related questions asked on a 1-5 scale, 1=most negative resonse to 5=most positive response, was used to derive vision scores. The analysis shows the difference in outcome between test and control. \>0=greater vision, \<0=lesser vision.
Time frame: 15-20 minutes
Population: Analysis includes participants who completed the study per protocol (n=88)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A Toric | Patient Reported Vision | 0.2845 Scores on a scale | Standard Error 0.098 |
| Alphafilcon A Toric | Patient Reported Vision | 0.1332 Scores on a scale | Standard Error 0.098 |
| Etafilcon A Sphere | Patient Reported Vision | -0.4310 Scores on a scale | Standard Error 0.097 |
Comparison: Alternative hypothesis was senofilcon A toric was superior to etafilcon A sphere.95% CI: [0.3625, 0.7155]Mixed Models Analysis
Primary
Visual Acuity
Number of eyes with Distance Visual Acuity 20/20 or better
Time frame: 15-20 minutes
Population: Analysis includes participants who completed the study per protocol (n=88 subjects,176 eyes)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Senofilcon A Toric | Visual Acuity | 146 Eyes with Snellen VA 20/20 or better |
| Alphafilcon A Toric | Visual Acuity | 136 Eyes with Snellen VA 20/20 or better |
| Etafilcon A Sphere | Visual Acuity | 37 Eyes with Snellen VA 20/20 or better |
Comparison: Alternative hypothesis was senofilcon A toric was superior to etafilcon A sphere by having more eyes see 20/20p-value: <0.0001Chi-squared