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The objective of this study is to evaluate the subjective acceptance of comfilcon A toric contact lens, compared to samfilcon A toric lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| comfilcon A toric lens | Experimental | Subjects who wear comfilcon A toric lens either as first or second pair during this cross-over study. |
|
| samfilcon A toric lens | Active Comparator | Subjects who wear samfilcon A toric lens either as first or second pair during this cross-over study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| comfilcon A toric lens | Device | Contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comfort at Insertion | Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens) | Dispense |
| Comfort | Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens) | 2 weeks |
| Comfort | Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens) | 1-month |
| 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) | 1 month |
| 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) | 1 month |
| Dryness | Subjective ratings of dryness for each pair of lenses (scale: 0-10; 0=Extremely dry, 10=No dryness) | 2 weeks |
| Dryness | Subjective ratings of dryness for each pair of lenses (scale: 0-10; 0=Extremely dry, 10=No dryness) | 1-month |
| Measure | Description | Time Frame |
|---|---|---|
| Ease of Insertion | Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy) | Dispense |
| Ease of Insertion | Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lyndon Jones, PhD FCOptom | Director, Centre for Ocular Research & Education | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Waterloo | Waterloo | Ontario | N2L 3G1 | Canada |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Comfilcon A Toric Then Samfilcon A Toric | Subjects were randomized to wear comfilcon A toric lenses for 1-month and then crossover to wear Samfilcon A toric lenses for 1-month. Contact Lens: comfilcon A toric Contact Lens: Samfilcon A toric |
| FG001 | Samfilcon A Toric Then Comfilcon A Toric | Subjects were randomized to wear sammfilcon A toric lenses for 1-month and then crossover to wear comfilcon A toric lenses for 1-month. Contact Lens: Samfilcon A toric Contact Lens: comfilcon A toric |
| 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 |
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| 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 | Comfort at Insertion | Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens) | Posted | Mean | Standard Deviation | units on a scale | Dispense |
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One month during each crossover period.
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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 Toric | 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. Contact Lens: comfilcon A toric |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose A.Vega OD, MSc., FAAO | CooperVision Inc. | 9256213761 | javega@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 | Feb 14, 2018 | Dec 11, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| samfilcon A toric lens | Device | Contact lens |
|
|
| 2-weeks |
| Ease of Insertion | Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy) | 1-month |
| Ease of Removal | Subjective rating of ease of removing the lens from the eye (scale 0-10; 0=very difficult, 10=very easy) | 2-weeks |
| Ease of Removal | Subjective rating of ease of removing the lens from the eye (scale 0-10; 0=very difficult, 10=very easy) | 1 month |
| NOT COMPLETED |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| Primary | Comfort | Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens) | One subject's subjective rating was excluded for comfilcon A toric due to subject confusion at rating scale and potentially reversing its use. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
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| Primary | Comfort | Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens) | Posted | Mean | Standard Deviation | units on a scale | 1-month |
|
|
|
| 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) | Percentages may be rounded and therefore may not add up to equal to 100% | Posted | Number | percentage of participants | 1 month |
|
|
|
| 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) | Posted | Number | percentage of participants | 1 month |
|
|
|
| Primary | Dryness | Subjective ratings of dryness for each pair of lenses (scale: 0-10; 0=Extremely dry, 10=No dryness) | One subject's subjective rating was excluded for comfilcon A toric due to subject confusion at rating scale and potentially reversing its use. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| Primary | Dryness | Subjective ratings of dryness for each pair of lenses (scale: 0-10; 0=Extremely dry, 10=No dryness) | Posted | Mean | Standard Deviation | units on a scale | 1-month |
|
|
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| Secondary | Ease of Insertion | Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy) | Posted | Mean | Standard Deviation | units on a scale | Dispense |
|
|
|
| Secondary | Ease of Insertion | Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy) | One subject's subjective rating was excluded for comfilcon A toric due to subject confusion at rating scale and potentially reversing its use. | Posted | Mean | Standard Deviation | units on a scale | 2-weeks |
|
|
|
| Secondary | Ease of Insertion | Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy) | Posted | Mean | Standard Deviation | units on a scale | 1-month |
|
|
|
| Secondary | Ease of Removal | Subjective rating of ease of removing the lens from the eye (scale 0-10; 0=very difficult, 10=very easy) | One subject's subjective rating was excluded for comfilcon A toric due to subject confusion at rating scale and potentially reversing its use. | Posted | Mean | Standard Deviation | units on a scale | 2-weeks |
|
|
|
| Secondary | Ease of Removal | Subjective rating of ease of removing the lens from the eye (scale 0-10; 0=very difficult, 10=very easy) | Posted | Mean | Standard Deviation | units on a scale | 1 month |
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| 0 |
| 45 |
| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | Samfilcon A Toric | Subjects were randomized to wear samfilcon A toric lenses for 1-month and comfilcon A toric lenses for 1-month in this cross-over dispensing study. Contact Lens: samfilcon A toric | 0 | 45 | 0 | 45 | 0 | 45 |
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| Title | Measurements |
|---|---|
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| Slightly prefer samfilcon A |
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| Strongly prefer samfilcon A |
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| Title |
|---|
| Measurements |
|---|
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| Slightly prefer samfilcon A |
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| Strongly prefer samfilcon A |
|