Astigmatism
Conditions
Brief summary
This study aims to compare the clinical performance and subjective acceptance of the comfilcon A and the omafilcon B soft contact lenses.
Detailed description
This will be a randomized, subject-masked, crossover, bilateral study, controlled by cross comparison. Thirty subjects will use each lens type for two weeks in random sequence. Follow-up visits for each lens will be performed after two weeks of wear. Lenses will be worn on a daily wear basis. The final optical design of comfilcon A contact lens was optimized to improve the quality and two further studies (CV-18-10 and CV-18-11) were conducted after completion of this study to evaluate the modified optical design.
Interventions
DEVICEcomfilcon A
toric contact lens
DEVICEomafilcon B
toric contact lens
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects will only be eligible for the study if: 1. They are aged 40 - 70 years, inclusive. 2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent. 3. They are willing and able to follow the protocol. 4. They have successfully completed the non-dispensing study (C16-597) as the lenses to be worn on this study (C16-599) are predetermined from their participation on study C16-597. 5. They have a contact lens spherical prescription between +10.00 to -10.00D (Diopters) (inclusive). 6. They have astigmatism between of -0.75 and -5.75DC (based on the calculated ocular refraction) in each eye. 7. They have an Add component to their spectacle refraction (between +0.75 and +2.50DS). 8. They can be satisfactorily fitted with the study lenses. 9. They can attain at least 0.30 logMAR binocular distance high contrast visual acuity with the study lenses within the available power range. 10. They have successfully worn soft contact lenses in the last two years. 11. They are willing to comply with the wear schedule (at least five days per week and for at least six hours per day). 12. They agree not to participate in other clinical research for the duration of this study. 13. They own a wearable pair of spectacles.
Exclusion criteria
* Subjects will not be eligible to take part in the study if: 1. They have an ocular disorder which would normally contra-indicate contact lens wear. 2. They have a systemic disorder which would normally contra-indicate contact lens wear. 3. They are using any topical medication such as eye drops or ointment. 4. They have had cataract surgery. 5. They have had corneal refractive surgery. 6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. 7. They are pregnant or breast-feeding. 8. They have any clinically meaningful slit lamp findings contraindicating contact lens wear (e.g. ≥ Grade 3 finding of oedema, corneal neovascularisation, corneal staining, tarsal abnormalities, conjunctival injection, blepharitis/meibomian gland dysfunction) on the Efron classification scale or any other ocular abnormality that in the opinion of the investigator would contraindicate contact lens wear. 9. They have any infectious disease (e.g. hepatitis) which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV). 10. They have a history of anaphylaxis or severe allergic reaction. 11. They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stability | Baseline | Investigator's acceptance on overall stability for comfilcon A and omafilcon B lenses assessed using grading scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for astigmatism, 4=Excellent orientation and optimum rotational. |
| Overall Toric Lens Fit Acceptance | Baseline | Overall toric lens fit acceptance is assessed for comfilcon A and omafilcon B lenses. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum. |
| Comfort | Baseline | Subjective ratings for comfort assessed. Scale 0-100, 0=cannot be worn, causes pain; 100=cannot be felt ever |
| Overall Satisfaction | 2 weeks | Subjective ratings for overall satisfaction for comfilcon A and omafilcon B lenses assessed. Scale 0-100, 0=extremely dissatisfied, 100=extremely satisfied |
| Dryness | 2 weeks | Subjective ratings for dryness assessed. Scale 0-100, 0=cannot be worn, extremely dry; 100=no dryness experienced at any time |
| Visual Fluctuation/ Stability | 2 weeks | Subjective ratings for visual fluctuation/stability assessed. Scale 0-100, 0=totally unstable/ fluctuation/changing; 100=perfectly stable/not fluctuation/changing |
| Handling | 2 weeks | Subjective ratings for handling difficulty assessed at 2 weeks. Scale 0-100, 0=very difficult, 100=very easy |
| Quality of Near Vision | 2 weeks | Subjective ratings for quality of near vision. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time. |
| Quality of Intermediate Vision | 2 weeks | Subjective ratings for quality of intermediate vision. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time. |
| Quality of Distance Vision | 2 weeks | Subjective ratings for quality of distance vision. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time. |
| Quality of Vision While Driving During the Day | 2 weeks | Subjective rating for quality of vision while driving during the day. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time. |
| Quality of Vision While Driving During the Night | 2 weeks | Subjective ratings for quality of vision while driving at night. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time. |
| Ghosting at Near | 2 weeks | Subjective ratings for ghosting at near assessed at 2 weeks. Scale 0-100, 0=intolerable, 100=not noticeable. |
| Ghosting at Distance | 2 weeks | Subjective ratings for ghosting at distance assessed at 2 weeks. Scale 0-100, 0=intolerable, 100=not noticeable. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Total Participants | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention | Unsatisfied Vision | 0 | 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 | 24 Participants | — |
| Age, Continuous | 56.2 years STANDARD_DEVIATION 6.2 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United Kingdom | 24 participants | — |
| Sex: Female, Male Female | 11 Participants | — |
| Sex: Female, Male Male | 13 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 21 |
| other Total, other adverse events | 0 / 24 | 0 / 21 |
| serious Total, serious adverse events | 0 / 24 | 0 / 21 |
Outcome results
Primary
Comfort
Subjective ratings for comfort assessed. Scale 0-100, 0=cannot be worn, causes pain; 100=cannot be felt ever
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Comfort | 81.6 units on a scale | Standard Deviation 20.3 |
| Omafilcon B | Comfort | 79.7 units on a scale | Standard Deviation 21.6 |
Primary
Comfort
Subjective ratings for comfort assessed. Scale 0-100, 0=cannot be worn, causes pain; 100=cannot be felt ever
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Comfort | 79.8 units on a scale | Standard Deviation 21.8 |
| Omafilcon B | Comfort | 70.6 units on a scale | Standard Deviation 27.2 |
Primary
Dryness
Subjective ratings for dryness assessed. Scale 0-100, 0=cannot be worn, extremely dry; 100=no dryness experienced at any time
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Dryness | 80.4 units on a scale | Standard Deviation 24.7 |
| Omafilcon B | Dryness | 77.2 units on a scale | Standard Deviation 24.1 |
Primary
Ghosting at Distance
Subjective ratings for ghosting at distance assessed at 2 weeks. Scale 0-100, 0=intolerable, 100=not noticeable.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Ghosting at Distance | 83.3 units on a scale | Standard Deviation 24.8 |
| Omafilcon B | Ghosting at Distance | 86.9 units on a scale | Standard Deviation 24.4 |
Primary
Ghosting at Near
Subjective ratings for ghosting at near assessed at 2 weeks. Scale 0-100, 0=intolerable, 100=not noticeable.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Ghosting at Near | 66.5 units on a scale | Standard Deviation 35 |
| Omafilcon B | Ghosting at Near | 78.1 units on a scale | Standard Deviation 27 |
Primary
Handling
Subjective ratings for handling difficulty assessed at 2 weeks. Scale 0-100, 0=very difficult, 100=very easy
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Handling | 84.5 units on a scale | Standard Deviation 15 |
| Omafilcon B | Handling | 85.8 units on a scale | Standard Deviation 17.1 |
Primary
Overall Satisfaction
Subjective ratings for overall satisfaction for comfilcon A and omafilcon B lenses assessed. Scale 0-100, 0=extremely dissatisfied, 100=extremely satisfied
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Overall Satisfaction | 63.0 units on a scale | Standard Deviation 31.4 |
| Omafilcon B | Overall Satisfaction | 63.3 units on a scale | Standard Deviation 34.4 |
Primary
Overall Toric Lens Fit Acceptance
Overall toric lens fit acceptance is assessed for comfilcon A and omafilcon B lenses. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Overall Toric Lens Fit Acceptance | 3.5 units on a scale | Standard Deviation 0.6 |
| Omafilcon B | Overall Toric Lens Fit Acceptance | 2.8 units on a scale | Standard Deviation 0.7 |
Primary
Overall Toric Lens Fit Acceptance
Overall toric lens fit acceptance is assessed for comfilcon A and omafilcon B lenses. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Overall Toric Lens Fit Acceptance | 3.3 units on a scale | Standard Deviation 0.5 |
| Omafilcon B | Overall Toric Lens Fit Acceptance | 3.2 units on a scale | Standard Deviation 0.6 |
Primary
Quality of Distance Vision
Subjective ratings for quality of distance vision. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Quality of Distance Vision | 86.2 units on a scale | Standard Deviation 13.7 |
| Omafilcon B | Quality of Distance Vision | 67.3 units on a scale | Standard Deviation 25.5 |
Primary
Quality of Intermediate Vision
Subjective ratings for quality of intermediate vision. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Quality of Intermediate Vision | 50.2 units on a scale | Standard Deviation 29.5 |
| Omafilcon B | Quality of Intermediate Vision | 65.3 units on a scale | Standard Deviation 25.6 |
Primary
Quality of Near Vision
Subjective ratings for quality of near vision. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Quality of Near Vision | 38.5 units on a scale | Standard Deviation 30.5 |
| Omafilcon B | Quality of Near Vision | 56.4 units on a scale | Standard Deviation 28.9 |
Primary
Quality of Vision While Driving During the Day
Subjective rating for quality of vision while driving during the day. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Quality of Vision While Driving During the Day | 87.3 units on a scale | Standard Deviation 14.6 |
| Omafilcon B | Quality of Vision While Driving During the Day | 76.2 units on a scale | Standard Deviation 25.4 |
Primary
Quality of Vision While Driving During the Night
Subjective ratings for quality of vision while driving at night. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Quality of Vision While Driving During the Night | 78.0 units on a scale | Standard Deviation 18.6 |
| Omafilcon B | Quality of Vision While Driving During the Night | 67.0 units on a scale | Standard Deviation 23.4 |
Primary
Stability
Investigator's acceptance on overall stability for comfilcon A and omafilcon B lenses assessed using grading scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for astigmatism, 4=Excellent orientation and optimum rotational.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Stability | 3.2 units on a scale | Standard Deviation 1.5 |
| Omafilcon B | Stability | 2.9 units on a scale | Standard Deviation 0.9 |
Primary
Stability
Investigator's acceptance on overall stability for comfilcon A and omafilcon B lenses assessed using grading scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for astigmatism, 4=Excellent orientation and optimum rotational.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Stability | 3.2 units on a scale | Standard Deviation 0.7 |
| Omafilcon B | Stability | 2.5 units on a scale | Standard Deviation 1 |
Primary
Visual Fluctuation/ Stability
Subjective ratings for visual fluctuation/stability assessed. Scale 0-100, 0=totally unstable/ fluctuation/changing; 100=perfectly stable/not fluctuation/changing
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Visual Fluctuation/ Stability | 81.0 units on a scale | Standard Deviation 16.1 |
| Omafilcon B | Visual Fluctuation/ Stability | 73.8 units on a scale | Standard Deviation 25.5 |