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This study was conducted to evaluate the clinical performance of an investigational silicone-hydrogel lens against Senofilcon A toric lens.
The study results were not used for design validation of the investigational product.
This will be a randomized, bilateral, 2-week cross-over, double-masked, dispensing study comparing the investigational test lens against the Senofilcon A Toric for Astigmatism control lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sapphire contact lenses | Experimental | Each subject randomized to wear either the Investigational lenses (test) or senofilcon A contact lenses (control) as a matched pair and cross over to the second matched pair. |
|
| senofilcon A | Active Comparator | Each subject randomized to wear either the Investigational lenses (test) or senofilcon A contact lenses (control) as a matched pair and cross over to the second matched pair. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sapphire contact lenses | Device | Each subject randomized to wear either the test or control contact lenses as a matched pair and cross over to the second matched pair |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Ratings for Comfort | Scale 0-100; (0=Cannot be worn; 100=Cannot be felt ever) | Baseline (10 minutes post lens settling) |
| Subjective Ratings for Comfort | Scale 0-100; (0=Cannot be worn; 100=Cannot be felt ever) | 2 weeks |
| Subjective Ratings for Comfort Preference | Subjective Ratings for Comfort Preference: Sapphire lens, senofilcon A lens, No preference | Baseline (10 minutes post lens settling) |
| Subjective Ratings for Comfort Preference | Subjective Ratings for Comfort Preference: Sapphire lens, senofilcon A lens, No preference | 2 weeks |
| Subjective Assessment of Visual Quality | Subjective assessment of visual quality assessed on a Scale: 0-100 (0=Extremely poor vision all of the time; Cannot function; 100=Excellent vision all of the time) | Baseline (10 minutes post lens settling) |
| Subjective Assessment of Visual Quality | Subjective assessment of visual quality assessed on a Scale: 0-100 (0=Extremely poor vision all of the time; Cannot function; 100=Excellent vision all of the time) | 2 weeks |
| Subjective Assessment of Overall Satisfaction | Subjective assessment of overall satisfaction on a Scale: 0-100: (0=Extremely dissatisfied; 100=Extremely satisfied) |
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Inclusion Criteria:
A person is eligible for inclusion in the study if they:
Are at least 18 years of age and have full legal capacity to volunteer;
Have read and signed an information consent letter;
Are willing and able to follow instructions and maintain the appointment schedule;
Are an adapted soft contact lens wearer;
Require spectacle lens powers in both eyes;
Are willing to wear contact lenses in both eyes;
Have manifest refraction visual acuities (VA) equal to or better than logMAR (log of the minimum angle of resolution) equivalent of 20/25 in each eye;
To be eligible for lens dispensing, the subject must have VA of logMAR equivalent of 20/30 or better in each eye with the study lenses and the investigator must judge the fit including toric orientation as acceptable.
Exclusion Criteria:
A person will be excluded from the study if they:
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| Name | Affiliation | Role |
|---|---|---|
| Michel Guillon | Ocular Technology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Family Eye Care Center | Campbell | California | 95008 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sapphire Test Lenses Then Senofilcon A Lenes | Each subject was randomized to wear the Investigational lenses (test) for two weeks then cross-over to senofilcon A contact lenses (control) for two weeks. Sapphire contact lenses: Contact Lenses Senofilcon A : Contact lenses |
| FG001 | Senofilcon A Then Sapphire Test Lenses | Each subject was randomized to wear the senofilcon A contact lenses (control) for two weeks then cross-over to Sapphire lenses (test) for two weeks. Senofilcon A : Contact lenses Sapphire lenses: Contact Lenses |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Second Intervention |
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Each subject randomized to wear either the Investigational lenses (test) or senofilcon A contact lenses (control) as a matched pair and cross over to the second matched pair.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Each subject randomized to wear either the Sapphire lenses (test) or senofilcon A contact lenses (control) as a matched pair for two weeks and cross over to the second matched pair for two weeks. |
| 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 | Subjective Ratings for Comfort | Scale 0-100; (0=Cannot be worn; 100=Cannot be felt ever) | One subject was excluded from the analysis due to compliance. | Posted | Mean | Standard Deviation | units on a scale | Baseline (10 minutes post lens settling) |
|
From dispense up to 2 weeks on each study lenses, a total of 4 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 | Sapphire Contact Lenses | Each subject randomized to wear the Sapphire lenses (test) for two weeks. Sapphire contact lenses: Contact lenses |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Myhanh Nguyen | CooperVision, Inc. | 925-730-6716 | mnguyen@coopervision.com |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| senofilcon A contact lenses | Device | Each subject randomized to wear either the test or control contact lenses as a matched pair and cross over to the second matched pair |
|
| Baseline (10 minutes post lens settling) |
| Subjective Assessment of Overall Satisfaction | Subjective assessment of overall satisfaction on a Scale: 0-100: (0=Extremely dissatisfied; 100=Extremely satisfied) | 2 weeks |
| Subjective Overall Preference | Subjective Overall Preference: Sapphire lens, senofilcon A lens, No preference | Baseline (10 minutes post lens settling) |
| Subjective Overall Preference | Subjective Overall Preference: Sapphire lens, senofilcon A lens, No preference | 2 weeks |
| NOT COMPLETED |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| 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 | Subjective Ratings for Comfort | Scale 0-100; (0=Cannot be worn; 100=Cannot be felt ever) | One subject was excluded from the analysis due to compliance. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| Primary | Subjective Ratings for Comfort Preference | Subjective Ratings for Comfort Preference: Sapphire lens, senofilcon A lens, No preference | One subject was excluded from the analysis due to compliance. | Posted | Number | percentage of participants | Baseline (10 minutes post lens settling) |
|
|
|
| Primary | Subjective Ratings for Comfort Preference | Subjective Ratings for Comfort Preference: Sapphire lens, senofilcon A lens, No preference | One subject was excluded from the analysis due to compliance. | Posted | Number | percentage of participants | 2 weeks |
|
|
|
| Primary | Subjective Assessment of Visual Quality | Subjective assessment of visual quality assessed on a Scale: 0-100 (0=Extremely poor vision all of the time; Cannot function; 100=Excellent vision all of the time) | One subject was excluded from the analysis due to compliance. | Posted | Mean | Standard Deviation | units on a scale | Baseline (10 minutes post lens settling) |
|
|
|
| Primary | Subjective Assessment of Visual Quality | Subjective assessment of visual quality assessed on a Scale: 0-100 (0=Extremely poor vision all of the time; Cannot function; 100=Excellent vision all of the time) | One subject was excluded from the analysis due to compliance. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| Primary | Subjective Assessment of Overall Satisfaction | Subjective assessment of overall satisfaction on a Scale: 0-100: (0=Extremely dissatisfied; 100=Extremely satisfied) | One subject was excluded from the analysis due to compliance | Posted | Mean | Standard Deviation | units on a scale | Baseline (10 minutes post lens settling) |
|
|
|
| Primary | Subjective Assessment of Overall Satisfaction | Subjective assessment of overall satisfaction on a Scale: 0-100: (0=Extremely dissatisfied; 100=Extremely satisfied) | One subject was excluded from the analysis due to compliance | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| Primary | Subjective Overall Preference | Subjective Overall Preference: Sapphire lens, senofilcon A lens, No preference | One subject was excluded from the analysis due to compliance. | Posted | Number | percentage of participants | Baseline (10 minutes post lens settling) |
|
|
|
| Primary | Subjective Overall Preference | Subjective Overall Preference: Sapphire lens, senofilcon A lens, No preference | One subject was excluded from the analysis due to compliance. | Posted | Number | percentage of participants | 2 weeks |
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| 0 |
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Senofilcon A | Each subject randomized to wear senofilcon A contact lenses (control) for two weeks. senofilcon A contact lenses: Contact lenses | 0 | 23 | 0 | 23 | 0 | 23 |
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