Astigmatism Bilateral
Conditions
Brief summary
The aim of this study is to evaluate the subjective acceptance of Comfilcon A contact lenses when worn on a daily wear modality over one month.
Detailed description
This study is a 30-subjects prospective, double-masked (investigator and participant), bilateral, randomized, one month cross-over dispensing study comparing subject acceptance of Comfilcon A against Senofilcon A contact lenses.
Interventions
DEVICEComfilcon A (test)
Daily wear contact lenses
DEVICESenofilcon C (control)
Daily wear contact lenses
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Prospective, double-masked, bilateral, randomized, one month cross-over dispensing study.
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
A person is eligible for inclusion in the study if he/she: 1. Is at least 17 years of age and has full legal capacity to volunteer; 2. Has had a self-reported oculo-visual examination in the last two years. 3. Has read and signed an information consent letter; 4. Is willing and able to follow instructions and maintain the appointment schedule; 5. Is an adapted soft contact lens wearer, who currently wears contact lenses for a minimum 3 days/week and 8 hours/day AND who anticipates no difficulty wearing CLs for 6 days/week, 10 hours /day. 6. Is willing to wear contact lens in both eyes for the duration of the study; 7. Has a minimum astigmatism of - 0.75, determined by refraction; 8. Can be fit with the two study contact lens types in the powers available; 9. Has a distance visual acuity of 0.20 logMAR (approx 20/30) or better, determined by refraction; 10. Can achieve a distance visual acuity of 0.20 logMAR (approx 20/30) or better in each eye with the study contact lenses. 11. Has clear corneas and no active\* ocular disease;
Exclusion criteria
A person will be excluded from the study if he/she: 1. Is participating in any concurrent clinical trial; 2. Has any known active\* ocular disease and/or infection; 3. Has a systemic condition that in the opinion of the investigator may affect a study measure; 4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study measure; 5. Has known sensitivity to fluorescein dye or products to be used in the study; 6. Appears to have any active\* ocular pathology, ocular anomaly or severe insufficiency of lacrimal secretion (severe dry eye) that would affect the wearing of contact lenses; 7. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit); 8. Is aphakic; 9. Has undergone refractive error surgery; 10. Has participated in the previous QUENA study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ease of Insertion(Handling) | Baseline | Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy) |
| Ease of Insertion (Handling) | 2 weeks | Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rotational Recovery After Lens Mislocation | Baseline | Lens relocation after 10 blinks, after 30º rotation mislocation |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Total Participants | 45 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention | Lost to Follow-up | 0 | 1 |
| First Intervention | Withdrawal by Subject | 0 | 2 |
| Second Intervention | Soft Tissue Injury | 1 | 0 |
Baseline characteristics
| Characteristic | Overall Study | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 45 Participants | — |
| Age, Continuous | 26.4 years STANDARD_DEVIATION 8.9 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Canada | 45 participants | — |
| Sex: Female, Male Female | 37 Participants | — |
| Sex: Female, Male Male | 8 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 45 |
| other Total, other adverse events | 0 / 45 | 0 / 45 |
| serious Total, serious adverse events | 0 / 45 | 0 / 45 |
Outcome results
Primary
Ease of Insertion (Handling)
Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy)
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A (Test) | Ease of Insertion (Handling) | 8.9 units on a scale | Standard Deviation 1.1 |
| Senofilcon C (Control) | Ease of Insertion (Handling) | 8.5 units on a scale | Standard Deviation 1.9 |
Primary
Ease of Insertion(Handling)
Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A (Test) | Ease of Insertion(Handling) | 9.1 units on a scale | Standard Deviation 1.2 |
| Senofilcon C (Control) | Ease of Insertion(Handling) | 9.2 units on a scale | Standard Deviation 1.1 |
Primary
Ease of Insertion(Handling)
Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy)
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A (Test) | Ease of Insertion(Handling) | 8.8 units on a scale | Standard Deviation 1.3 |
| Senofilcon C (Control) | Ease of Insertion(Handling) | 8.5 units on a scale | Standard Deviation 1.7 |
Secondary
Rotational Recovery After Lens Mislocation
Lens relocation after 10 blinks, after 30º rotation mislocation
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comfilcon A (Test) | Rotational Recovery After Lens Mislocation | Nasal | 27 Degrees | Standard Deviation 4 |
| Comfilcon A (Test) | Rotational Recovery After Lens Mislocation | Temporal | 23 Degrees | Standard Deviation 8 |
| Senofilcon C (Control) | Rotational Recovery After Lens Mislocation | Nasal | 23 Degrees | Standard Deviation 6 |
| Senofilcon C (Control) | Rotational Recovery After Lens Mislocation | Temporal | 19 Degrees | Standard Deviation 5 |
Secondary
Rotational Recovery After Lens Mislocation
Lens relocation after 10 blinks, after 30º rotation mislocation.
Time frame: 1 month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comfilcon A (Test) | Rotational Recovery After Lens Mislocation | Nasal | 26 Degrees | Standard Deviation 6 |
| Comfilcon A (Test) | Rotational Recovery After Lens Mislocation | Temporal | 23 Degrees | Standard Deviation 7 |
| Senofilcon C (Control) | Rotational Recovery After Lens Mislocation | Nasal | 23 Degrees | Standard Deviation 6 |
| Senofilcon C (Control) | Rotational Recovery After Lens Mislocation | Temporal | 18 Degrees | Standard Deviation 5 |