Astigmatism
Conditions
Brief summary
The objective of this study is to evaluate the subjective acceptance of comfilcon A toric contact lens, compared to samfilcon A toric lens.
Interventions
DEVICEcomfilcon A toric lens
Contact lens
DEVICEsamfilcon A toric lens
Contact lens
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Is at least 17 years of age and has full legal capacity to volunteer; * Has had a self-reported oculo-visual examination in the last two years. * Has read and signed an information consent letter; * Is willing and able to follow instructions and maintain the appointment schedule; * 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. * Is willing to wear contact lens in both eyes for the duration of the study; * Has a minimum astigmatism of - 0.75, determined by refraction; * Can be fit with the two study contact lens types in the powers available; * Has a distance visual acuity of 0.20 logMAR (approx 20/30) or better, determined by refraction; * Can achieve a distance visual acuity of 0.20 logMAR (approx 20/30) or better in each eye with the study contact lenses. * Has clear corneas and no active\* ocular disease
Exclusion criteria
* Is participating in any concurrent clinical trial; * Has any known active\* ocular disease and/or infection; * Has a systemic condition that in the opinion of the investigator may affect a study measure; * Is using any systemic or topical medications that in the opinion of the investigator may affect a study measure; * Has known sensitivity to fluorescein dye or products to be used in the study; * 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; * Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit); * Is aphakic; * Has undergone refractive error surgery. * Has participated in the PIANO (i.e. EX-MKTG-83) Study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comfort | 2 weeks | Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens) |
| Lens Preference Based on Overall Dryness | 1 month | Lens preference with respect to dryness (Prefer pair-1 strongly, Prefer pair-1 slightly, Prefer pair-2 strongly, prefer pair-2 slightly, No preference) |
| Dryness | 2 weeks | Subjective ratings of dryness for each pair of lenses (scale: 0-10; 0=Extremely dry, 10=No dryness) |
| Comfort at Insertion | Dispense | Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens) |
| Lens Preference Based on Overall Comfort | 1 month | Lens preference with respect to comfort (Prefer pair-1 strongly, Prefer pair-1 slightly, Prefer pair-2 strongly, prefer pair-2 slightly, No preference) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ease of Removal | 2-weeks | Subjective rating of ease of removing the lens from the eye (scale 0-10; 0=very difficult, 10=very easy) |
| Ease of Insertion | Dispense | Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy) |
Countries
Canada
Participant flow
Pre-assignment details
Subjects were randomized to wear comfilcon A toric lenses for 1-month and samfilcon A toric lenses for 1-month in this cross-over dispensing study.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Total Participants | 49 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention | Adverse Event | 1 | 3 |
Baseline characteristics
| Characteristic | Overall Study | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 49 Participants | — |
| Age, Continuous | 26.5 years STANDARD_DEVIATION 8.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Canada | 49 participants | — |
| Sex: Female, Male Female | 40 Participants | — |
| Sex: Female, Male Male | 9 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
Comfort
Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)
Time frame: 2 weeks
Population: One subject's subjective rating was excluded for comfilcon A toric due to subject confusion at rating scale and potentially reversing its use.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comfilcon A Toric Lens | Comfort | Overall | 8.1 units on a scale | Standard Deviation 1.4 |
| Comfilcon A Toric Lens | Comfort | Removal | 7.2 units on a scale | Standard Deviation 2.1 |
| Samfilcon A Toric Lens | Comfort | Overall | 7.4 units on a scale | Standard Deviation 2.1 |
| Samfilcon A Toric Lens | Comfort | Removal | 6.5 units on a scale | Standard Deviation 2.4 |
Primary
Comfort
Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)
Time frame: 1-month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comfilcon A Toric Lens | Comfort | Overall | 8.1 units on a scale | Standard Deviation 1.6 |
| Comfilcon A Toric Lens | Comfort | Removal | 7.1 units on a scale | Standard Deviation 2.1 |
| Samfilcon A Toric Lens | Comfort | Overall | 7.4 units on a scale | Standard Deviation 2.1 |
| Samfilcon A Toric Lens | Comfort | Removal | 6.7 units on a scale | Standard Deviation 2.5 |
Primary
Comfort at Insertion
Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)
Time frame: Dispense
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A Toric Lens | Comfort at Insertion | 9.0 units on a scale | Standard Deviation 1.2 |
| Samfilcon A Toric Lens | Comfort at Insertion | 8.8 units on a scale | Standard Deviation 1.2 |
Primary
Dryness
Subjective ratings of dryness for each pair of lenses (scale: 0-10; 0=Extremely dry, 10=No dryness)
Time frame: 2 weeks
Population: One subject's subjective rating was excluded for comfilcon A toric due to subject confusion at rating scale and potentially reversing its use.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comfilcon A Toric Lens | Dryness | Overall | 7.4 units on a scale | Standard Deviation 2 |
| Comfilcon A Toric Lens | Dryness | Removal | 6.5 units on a scale | Standard Deviation 2.5 |
| Samfilcon A Toric Lens | Dryness | Overall | 6.9 units on a scale | Standard Deviation 2.2 |
| Samfilcon A Toric Lens | Dryness | Removal | 6.0 units on a scale | Standard Deviation 2.3 |
Primary
Dryness
Subjective ratings of dryness for each pair of lenses (scale: 0-10; 0=Extremely dry, 10=No dryness)
Time frame: 1-month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comfilcon A Toric Lens | Dryness | Overall | 7.5 units on a scale | Standard Deviation 1.8 |
| Comfilcon A Toric Lens | Dryness | Removal | 6.6 units on a scale | Standard Deviation 2.3 |
| Samfilcon A Toric Lens | Dryness | Overall | 6.7 units on a scale | Standard Deviation 2.5 |
| Samfilcon A Toric Lens | Dryness | Removal | 6.2 units on a scale | Standard Deviation 2.6 |
Primary
Lens Preference Based on Overall Comfort
Lens preference with respect to comfort (Prefer pair-1 strongly, Prefer pair-1 slightly, Prefer pair-2 strongly, prefer pair-2 slightly, No preference)
Time frame: 1 month
Population: Percentages may be rounded and therefore may not add up to equal to 100%
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A Toric Lens | Lens Preference Based on Overall Comfort | Strongly prefer comfilcon A | 44 percentage of participants |
| Comfilcon A Toric Lens | Lens Preference Based on Overall Comfort | Slightly Prefer comfilcon A | 27 percentage of participants |
| Comfilcon A Toric Lens | Lens Preference Based on Overall Comfort | No Preference | 7 percentage of participants |
| Comfilcon A Toric Lens | Lens Preference Based on Overall Comfort | Slightly prefer samfilcon A | 7 percentage of participants |
| Comfilcon A Toric Lens | Lens Preference Based on Overall Comfort | Strongly prefer samfilcon A | 16 percentage of participants |
Primary
Lens Preference Based on Overall Dryness
Lens preference with respect to dryness (Prefer pair-1 strongly, Prefer pair-1 slightly, Prefer pair-2 strongly, prefer pair-2 slightly, No preference)
Time frame: 1 month
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A Toric Lens | Lens Preference Based on Overall Dryness | Strongly prefer comfilcon A | 29 percentage of participants |
| Comfilcon A Toric Lens | Lens Preference Based on Overall Dryness | Slightly prefer comfilcon A | 33 percentage of participants |
| Comfilcon A Toric Lens | Lens Preference Based on Overall Dryness | No Preference | 16 percentage of participants |
| Comfilcon A Toric Lens | Lens Preference Based on Overall Dryness | Slightly prefer samfilcon A | 4 percentage of participants |
| Comfilcon A Toric Lens | Lens Preference Based on Overall Dryness | Strongly prefer samfilcon A | 18 percentage of participants |
Secondary
Ease of Insertion
Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy)
Time frame: Dispense
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A Toric Lens | Ease of Insertion | 9.3 units on a scale | Standard Deviation 1 |
| Samfilcon A Toric Lens | Ease of Insertion | 9.3 units on a scale | Standard Deviation 0.9 |
Secondary
Ease of Insertion
Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy)
Time frame: 2-weeks
Population: One subject's subjective rating was excluded for comfilcon A toric due to subject confusion at rating scale and potentially reversing its use.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A Toric Lens | Ease of Insertion | 8.9 units on a scale | Standard Deviation 1.5 |
| Samfilcon A Toric Lens | Ease of Insertion | 8.4 units on a scale | Standard Deviation 1.9 |
Secondary
Ease of Insertion
Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy)
Time frame: 1-month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A Toric Lens | Ease of Insertion | 9.0 units on a scale | Standard Deviation 1.4 |
| Samfilcon A Toric Lens | Ease of Insertion | 8.3 units on a scale | Standard Deviation 1.8 |
Secondary
Ease of Removal
Subjective rating of ease of removing the lens from the eye (scale 0-10; 0=very difficult, 10=very easy)
Time frame: 2-weeks
Population: One subject's subjective rating was excluded for comfilcon A toric due to subject confusion at rating scale and potentially reversing its use.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A Toric Lens | Ease of Removal | 7.9 units on a scale | Standard Deviation 2.5 |
| Samfilcon A Toric Lens | Ease of Removal | 8.4 units on a scale | Standard Deviation 1.8 |
Secondary
Ease of Removal
Subjective rating of ease of removing the lens from the eye (scale 0-10; 0=very difficult, 10=very easy)
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A Toric Lens | Ease of Removal | 8.0 units on a scale | Standard Deviation 2.4 |
| Samfilcon A Toric Lens | Ease of Removal | 8.5 units on a scale | Standard Deviation 1.7 |