Astigmatism
Conditions
Keywords
Astigmatism, vision, comfort, satisfaction, contact lenses
Brief summary
The purpose of this study is to determine the relative performance of a new toric soft contact lens against a toric contact lens currently available in market, specifically with regards to the comfort and vision after two weeks of use.
Detailed description
Dispensing, single-masked (subject-masked), randomized, 2-visit controlled study of two-weeks duration.
Interventions
DEVICEsenofilcon A toric
contact lens
DEVICEalphafilcon A toric
contact lens
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
Prior to being considered eligible to participate in this study, subjects MUST 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 |
|---|---|---|
| Subjective Reported Vision | 1 week | A weighted combined score of one week and two week data calculated from individual vision-related questions asked on a 1-5 scale, 1 = most negative response to 5 = most positive, was used to derive vision outcomes. The analysis shows the outcome for both senofilcon A and alphafilcon A. If score \>0 then greater vision, if \<0 then lesser vision. |
| Subject Reported Lens Comfort. | 1 week | A weighted combined score of one week and two week data 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 estimates for senofilcon A and alphafilcon A, respectively. Interpretation is \>0 indicates comfortable and \<0 indicates uncomfortable. |
Participant flow
Pre-assignment details
Of those 96 enrolled subjects in the study, 7 did not meet the study eligibility criteria and 1 did not receive the study lenses. One enrolled subject was discontinued from the study leaving n=87 who completed the study.
Participants by arm
| Arm | Count |
|---|---|
| All Subjects Subjects who enrolled and completed the study. | 87 |
| Total | 87 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Continuous | 28.0 years STANDARD_DEVIATION 5.98 |
| Sex: Female, Male Female | 51 Participants |
| Sex: Female, Male Male | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 96 | 0 / 96 |
| serious Total, serious adverse events | 0 / 96 | 0 / 96 |
Outcome results
Primary
Subjective Reported Vision
A weighted combined score of one week and two week data calculated from individual vision-related questions asked on a 1-5 scale, 1 = most negative response to 5 = most positive, was used to derive vision outcomes. The analysis shows the outcome for both senofilcon A and alphafilcon A. If score \>0 then greater vision, if \<0 then lesser vision.
Time frame: 1 week
Population: Analysis includes only participants who completed the study per protocol and had no missing data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A Toric | Subjective Reported Vision | 0.33 Units on a scale | Standard Deviation 0.795 |
| Alphafilcon A Toric | Subjective Reported Vision | -0.17 Units on a scale | Standard Deviation 0.788 |
Primary
Subject Reported Lens Comfort.
A weighted combined score of one week and two week data 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 estimates for senofilcon A and alphafilcon A, respectively. Interpretation is \>0 indicates comfortable and \<0 indicates uncomfortable.
Time frame: 1 week
Population: Analysis includes only participants who completed the study per protocol and had no missing data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A Toric | Subject Reported Lens Comfort. | 0.37 Units on a scale | Standard Deviation 0.73 |
| Alphafilcon A Toric | Subject Reported Lens Comfort. | -0.38 Units on a scale | Standard Deviation 0.723 |