Ametropia
Conditions
Keywords
toric contact lenses, vision, comfort, toric fit characteristics, slit lamp findings
Brief summary
The purpose of this study is to evaluate and compare the clinical performance of two toric contact lenses amongst 110 subjects, 2-week, single masked (subject), daily wear, randomized, bilateral, crossover study; 4 weeks duration. Hypotheses include equal or better performance of the test lens over the control lenses for comfort, vision, and toric fit characteristics as well as corneal integrity
Detailed description
Up to 7 sites in the US will participate. Each investigator will have both test and control lens types. There will be a maximum of 6 scheduled visits: Visit 1: Habitual lens evaluation / Baseline / Trial fitting Visit 2: Dispensing (to be combined with Visit 1 where possible), Visit 3: Questionnaire only (no exam) 7 days (±2) after dispensing, Visit 4: 2 week follow-up 14 days (±3) after dispensing, and dispense second lens type, Visit 5: Questionnaire only (no exam) 7 days (±2) after 2nd lens dispense, Visit 6: 2 week follow-up 14 days (±3) after 2nd lens dispense
Interventions
DEVICEsenofilcon A toric
silicone hydrogel toric lens, 2 wk replacement, daily wear
DEVICEalphafilcon A toric
hydrogel toric lens, 2 wk replacement, daily wear
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 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Be at least 18 and less than or equal to 45 years of age, have a need for vision correction and wear contact lenses in BOTH eyes (monovision or uni-ocular fitting is NOT allowed). 2. Be able to read J1 at near WITHOUT the aid of a near addition over the distance prescription. 3. Be a currently successful wearer for at least 3 months of B&L SofLens 66 Toric hydrogel lenses. 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 spectacle spherical component between -1.00 D and -5.25 D with cylinder in the range of 0.75 D to 2.25 D and cylinder axis within 10 ° of the vertical and within 30° of the horizontal in both eyes (when the subject's prescription is presented in minus cylinder form). 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. Must be given an explanation of the study objectives, lens and solutions usage requirements and visit schedule. The subject must read, indicate understanding of and agree to begin participation in the clinical study. The subject must then sign the Informed Consent Form in the presence of the Investigator or their designee.
Exclusion criteria
1. Presbyopic or has the need for a near add for reading. 2. Previous refractive surgery; current or previous orthokeratology treatment. 3. Aphakia, keratoconus or a highly irregular cornea. 4. The presence of ocular or systemic disease or has the need for medication (ocular or systemic) which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (e.g., Sjögren's syndrome, type II diabetes, allergies). 5. A known history of corneal hypoesthesia (reduced corneal sensitivity.) 6. Anterior uveitis or iritis (past or present). 7. A history of recurrent erosions, corneal infiltrates corneal ulcer or fungal infections. 8. Clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations or infections of the eye, eyelids, or associated structures. 9. 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 * Meibomian gland dysfunction, blepharitis, or seborrhoeic dermatitis 10. Current pregnancy or lactation (to the best of the subject's knowledge). 11. Actively participating in another clinical study at any time during this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lens Orientation Within 5 Degrees | 1 minute after insertion | Number of eyes with lens orientation within 5 degrees of optimal orientation within 1 minute of contact lens insertion. |
| Lens Stability | 10-15 minutes after insertion | Number of eyes with the amount of rotation induced from a blink within 5 degrees of settled orientation. |
| Subjective Lens Comfort | 1 and 2 weeks | 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. |
| Subjective Vision | 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. The analysis shows the difference in outcome between the test and control. \>0=satisfactory vision, \<0=unsatisfactory vision. |
| Overall Corneal Staining | after 2 weeks use | Corneal staining measured using the National Eye Institute grading scale of grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Total Completed Participants | 84 |
| Total | 84 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 - 2 Weeks | lens issue | 3 | 0 |
| Period 1 - 2 Weeks | Lost to Follow-up | 2 | 0 |
Baseline characteristics
| Characteristic | Total Completed Participants |
|---|---|
| Age, Continuous | 31.6 years STANDARD_DEVIATION 8.05 |
| Sex: Female, Male Female | 53 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 44 | 0 / 45 |
| serious Total, serious adverse events | 0 / 44 | 0 / 45 |
Outcome results
Primary
Lens Orientation Within 5 Degrees
Number of eyes with lens orientation within 5 degrees of optimal orientation within 1 minute of contact lens insertion.
Time frame: 1 minute after insertion
Population: Subjects/eyes that completed the study were analyzed. A total of 168 eyes/84 subjects were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Senofilcon A Toric | Lens Orientation Within 5 Degrees | 128 Eyes |
| Alphafilcon A Toric | Lens Orientation Within 5 Degrees | 128 Eyes |
Comparison: Alternative hypothesis is that senofilcon A toric is non-inferior to alphafilcon A toric for proportion of eyes with lens orientation within 5 degrees.98.98% CI: [0.436, 0.967]Regression, Logistic
Primary
Lens Stability
Number of eyes with the amount of rotation induced from a blink within 5 degrees of settled orientation.
Time frame: 10-15 minutes after insertion
Population: Subjects/eyes that completed the study were analyzed. A total of 168 eyes/84 subjects were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Senofilcon A Toric | Lens Stability | 144 Eyes |
| Alphafilcon A Toric | Lens Stability | 138 Eyes |
Comparison: Alternative hypothesis is that senofilcon A toric is non-inferior to alphafilcon A toric for proportion of eyes with lens stability within 5 degrees.98.98% CI: [0.68, 1.416]Regression, Logistic
Primary
Overall Corneal Staining
Corneal staining measured using the National Eye Institute grading scale of grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe.
Time frame: after 2 weeks use
Population: Subjects that completed the study were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A Toric | Overall Corneal Staining | 0.04921 Units on a scale | Standard Error 0.01174 |
| Alphafilcon A Toric | Overall Corneal Staining | 0.06188 Units on a scale | Standard Error 0.01176 |
Comparison: Alternative hypothesis is senofilcon A toric is non-inferior to alphafilcon A toric by having a lower level of corneal staining.98.98% CI: [-0.01267, 0.01986]
Primary
Subjective Lens 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: 1 and 2 weeks
Population: Subjects that completed the study were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A Toric | Subjective Lens Comfort | 0.08125 Units on a scale | Standard Error 0.08771 |
| Alphafilcon A Toric | Subjective Lens Comfort | -0.1055 Units on a scale | Standard Error 0.08771 |
Comparison: Alternative hypothesis is that senofilcon A toric is non-inferior to alphafilcon A toric for lens comfort.98.98% CI: [-0.0517, 0.1868]Mixed Models Analysis
Primary
Subjective 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. The analysis shows the difference in outcome between the test and control. \>0=satisfactory vision, \<0=unsatisfactory vision.
Time frame: 1 and 2 weeks
Population: Subjects that completed the study were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A Toric | Subjective Vision | -0.0420 Units on a scale | Standard Error 0.08885 |
| Alphafilcon A Toric | Subjective Vision | -0.0302 Units on a scale | Standard Error 0.08885 |
Comparison: Alternative hypothesis is that senofilcon A toric is non-inferior to alphafilcon A toric for subjective vision.98.98% CI: [-0.2337, -0.01185]Mixed Models Analysis