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| Name | Class |
|---|---|
| Sengi | INDUSTRY |
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To subjectively evaluate wearing experience in the T30fA lens among subjects who were already satisfied with their Biofinity Toric lenses.
This study is a single site, prospective, observational study of the subjective performance of T30fA in symptomatic patients. Subjects will be assessed at a screening visit, and 2 follow-up visits. Clinical evaluations will include measurement of visual acuity, manifest refraction, and patient questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dailies Total1® contact lenses for astigmatism (T30fA) | Dailies Total1® contact lenses for astigmatism (T30fA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dailies Total1® contact lenses for astigmatism (T30fA) | Device | Dailies Total1® contact lenses for astigmatism (T30fA) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction With Comfort of T30fA Lens | Subjects will give a rating between 0 and 10 (with 0 indicating not satisfactory at all and 10 indicating extremely satisfactory) best describing their comfort. | After 1 month of wear |
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| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction With Visual Performance of T30fA Lens | Subjects will give a rating between 0 and 10 (with 0 indicating not satisfactory at all and 10 indicating extremely satisfactory) best describing their comfort. | After 1 month of wear |
| Satisfaction With End of Day Comfort of T30fA Lens |
Inclusion Criteria:
Subjects are eligible for the study if they meet the following criteria:
Note: Ocular criteria must be met in both eyes.
Exclusion Criteria:
If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
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Eligible participants will be 18-45 years of age who are current Biofinity Toric wearers and appropriate candidates for contact lens wear.
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| Name | Affiliation | Role |
|---|---|---|
| Jay Mashouf, OD | Scripps Poway Eyecare & Optometry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Poway Eyecare & Optometry | San Diego | California | 92131 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dailies Total1® Contact Lenses for Astigmatism (T30fA) | Dailies Total1® contact lenses for astigmatism (T30fA) Dailies Total1® contact lenses for astigmatism (T30fA): Dailies Total1® contact lenses for astigmatism (T30fA) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dailies Total1® Contact Lenses for Astigmatism (T30fA) | Dailies Total1® contact lenses for astigmatism (T30fA) Dailies Total1® contact lenses for astigmatism (T30fA): Dailies Total1® contact lenses for astigmatism (T30fA) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Satisfaction With Comfort of T30fA Lens | Subjects will give a rating between 0 and 10 (with 0 indicating not satisfactory at all and 10 indicating extremely satisfactory) best describing their comfort. | Posted | Median | Inter-Quartile Range | score on a scale | After 1 month of wear |
|
|
4 weeks of lehfilcon A wear
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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 | Dailies Total1® Contact Lenses for Astigmatism (T30fA) | Dailies Total1® contact lenses for astigmatism (T30fA) Dailies Total1® contact lenses for astigmatism (T30fA): Dailies Total1® contact lenses for astigmatism (T30fA) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Jay Mashouf | Scripps Optometric Group | 1-858-530-2800 | jaymashouf@gmail.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 19, 2023 | Aug 28, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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Subjects will give a rating between 0 and 10 (with 0 indicating not satisfactory at all and 10 indicating extremely satisfactory) best describing their comfort. |
| After 1 month of wear |
| Satisfaction With Ease of Handling of T30fA Lens | Subjects will give a rating between 0 and 10 (with 0 indicating not satisfactory at all and 10 indicating extremely satisfactory) best describing their comfort. | After 1 month of wear |
| Satisfaction Overall of Handling of T30fA Lens | Subjects will give a rating between 0 and 10 (with 0 indicating not satisfactory at all and 10 indicating extremely satisfactory) best describing their comfort. | After 1 month of wear |
| 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 |
|
|
| Other Pre-specified | Satisfaction With Visual Performance of T30fA Lens | Subjects will give a rating between 0 and 10 (with 0 indicating not satisfactory at all and 10 indicating extremely satisfactory) best describing their comfort. | Posted | Median | Inter-Quartile Range | score on a scale | After 1 month of wear |
|
|
|
| Other Pre-specified | Satisfaction With End of Day Comfort of T30fA Lens | Subjects will give a rating between 0 and 10 (with 0 indicating not satisfactory at all and 10 indicating extremely satisfactory) best describing their comfort. | Posted | Median | Inter-Quartile Range | score on a scale | After 1 month of wear |
|
|
|
| Other Pre-specified | Satisfaction With Ease of Handling of T30fA Lens | Subjects will give a rating between 0 and 10 (with 0 indicating not satisfactory at all and 10 indicating extremely satisfactory) best describing their comfort. | Posted | Median | Inter-Quartile Range | score on a scale | After 1 month of wear |
|
|
|
| Other Pre-specified | Satisfaction Overall of Handling of T30fA Lens | Subjects will give a rating between 0 and 10 (with 0 indicating not satisfactory at all and 10 indicating extremely satisfactory) best describing their comfort. | Posted | Median | Inter-Quartile Range | score on a scale | After 1 month of wear |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
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