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This study aims to compare the clinical performance and subjective acceptance of the comfilcon A and the omafilcon B soft contact lenses.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| comfilcon A | Experimental | Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study. 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. |
|
| omafilcon B | Active Comparator | Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| comfilcon A | Device | toric contact lens |
| |
| omafilcon B |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| 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. | 2 weeks |
| 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. | Baseline |
| 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. | 2 weeks |
| Comfort | Subjective ratings for comfort assessed. Scale 0-100, 0=cannot be worn, causes pain; 100=cannot be felt ever | Baseline |
| Comfort | Subjective ratings for comfort assessed. Scale 0-100, 0=cannot be worn, causes pain; 100=cannot be felt ever | 2 weeks |
| Overall Satisfaction |
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Inclusion Criteria:
Subjects will only be eligible for the study if:
They are aged 40 - 70 years, inclusive.
They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
They are willing and able to follow the protocol.
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.
They have a contact lens spherical prescription between +10.00 to -10.00D (Diopters) (inclusive).
They have astigmatism between of -0.75 and -5.75DC (based on the calculated ocular refraction) in each eye.
They have an Add component to their spectacle refraction (between +0.75 and
+2.50DS).
They can be satisfactorily fitted with the study lenses.
They can attain at least 0.30 logMAR binocular distance high contrast visual acuity with the study lenses within the available power range.
They have successfully worn soft contact lenses in the last two years.
They are willing to comply with the wear schedule (at least five days per week and for at least six hours per day).
They agree not to participate in other clinical research for the duration of this study.
They own a wearable pair of spectacles.
Exclusion Criteria:
Subjects will not be eligible to take part in the study if:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurolens Research | Manchester | M13 9PL | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Comfilcon A Then Omafilcon B | Participants were randomized to wear comfilcon A for two weeks during the cross over study. comfilcon A: toric contact lens |
| FG001 | Omafilcon B Then Comfilcon A | Participants were randomized to wear omafilcon B for two weeks during the cross over study. omafilcon B: toric contact lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| ||||||||||||||||||
| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Total Participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
From baseline to follow up visit for an average of 2 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Comfilcon A | Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study. comfilcon A: toric contact lens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Myhanh Nguyen | CooperVision | 9257306716 | MNguyen@coopervision.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 2, 2016 | Apr 29, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Device |
toric contact lens |
|
Subjective ratings for overall satisfaction for comfilcon A and omafilcon B lenses assessed. Scale 0-100, 0=extremely dissatisfied, 100=extremely satisfied
| 2 weeks |
| Dryness | Subjective ratings for dryness assessed. Scale 0-100, 0=cannot be worn, extremely dry; 100=no dryness experienced at any time | 2 weeks |
| Visual Fluctuation/ Stability | Subjective ratings for visual fluctuation/stability assessed. Scale 0-100, 0=totally unstable/ fluctuation/changing; 100=perfectly stable/not fluctuation/changing | 2 weeks |
| Handling | Subjective ratings for handling difficulty assessed at 2 weeks. Scale 0-100, 0=very difficult, 100=very easy | 2 weeks |
| 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. | 2 weeks |
| 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. | 2 weeks |
| 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. | 2 weeks |
| 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. | 2 weeks |
| 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. | 2 weeks |
| Ghosting at Near | Subjective ratings for ghosting at near assessed at 2 weeks. Scale 0-100, 0=intolerable, 100=not noticeable. | 2 weeks |
| Ghosting at Distance | Subjective ratings for ghosting at distance assessed at 2 weeks. Scale 0-100, 0=intolerable, 100=not noticeable. | 2 weeks |
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|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| Primary | Comfort | Subjective ratings for comfort assessed. Scale 0-100, 0=cannot be worn, causes pain; 100=cannot be felt ever | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Comfort | Subjective ratings for comfort assessed. Scale 0-100, 0=cannot be worn, causes pain; 100=cannot be felt ever | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| 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 | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| Primary | Dryness | Subjective ratings for dryness assessed. Scale 0-100, 0=cannot be worn, extremely dry; 100=no dryness experienced at any time | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| 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 | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| Primary | Handling | Subjective ratings for handling difficulty assessed at 2 weeks. Scale 0-100, 0=very difficult, 100=very easy | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| Primary | Ghosting at Near | Subjective ratings for ghosting at near assessed at 2 weeks. Scale 0-100, 0=intolerable, 100=not noticeable. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| Primary | Ghosting at Distance | Subjective ratings for ghosting at distance assessed at 2 weeks. Scale 0-100, 0=intolerable, 100=not noticeable. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Omafilcon B | Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study. omafilcon B: toric contact lens | 0 | 21 | 0 | 21 | 0 | 21 |
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