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| Name | Class |
|---|---|
| Sengi | INDUSTRY |
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To subjectively evaluate Dailies Total1® contact lenses for astigmatism (DT1fA) performance compared to other common weekly/monthly contact lenses in symptomatic patients.
This study is a single site, prospective, subject-masked, observational study of the subjective performance of DT1fA 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 |
|---|---|---|---|
| Bilateral use of DT1fA contact lenses | DT1fA contact lenses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DT1fA | Device | DT1fA contact lenses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score | A series of 8 questions that ask participants to rate eye discomfort, eye dryness, and blurry vision on a frequency scale (0 Never, 1 Rarely, 2 Sometimes, 3 Frequently, 4 Constantly) and an intensity scale (0 Never, 1 not intense to 5 Very Intense). Scores on individual questions are added together to determine a total score. Higher values indicate worse outcomes. The minimum score is 1 and the maximum score is 37. | Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A) |
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| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Participants That Reported Little to no Intensity of Eye Discomfort at Baseline and 2 Weeks of DT1fA Wear for End of Day (EOD) | Participants were asked to rate end of day discomfort intensity (0 Never, 1 not intense to 5 Very Intense). Higher values indicate worse outcomes. | Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A) |
Subjects are eligible for the study if they meet the following criteria:
Note: Ocular criteria must be met in both eyes.
Inclusion Criteria:
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 18-38 years of age who are current and appropriate candidates for contact lens wear.
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| Name | Affiliation | Role |
|---|---|---|
| Keith Wan, 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 | Bilateral Use of DT1fA Contact Lenses | DT1fA contact lenses DT1fA: DT1fA contact lenses |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bilateral Use of DT1fA Contact Lenses | DT1fA contact lenses DT1fA: DT1fA contact lenses |
| 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 | Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score | A series of 8 questions that ask participants to rate eye discomfort, eye dryness, and blurry vision on a frequency scale (0 Never, 1 Rarely, 2 Sometimes, 3 Frequently, 4 Constantly) and an intensity scale (0 Never, 1 not intense to 5 Very Intense). Scores on individual questions are added together to determine a total score. Higher values indicate worse outcomes. The minimum score is 1 and the maximum score is 37. | Posted | Mean | Standard Deviation | score on a scale | Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A) |
|
2 months
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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 | Bilateral Use of DT1fA Contact Lenses | DT1fA contact lenses DT1fA: DT1fA contact lenses |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Keith Wan | Scripps Optometric Group | 858-530-2800 | keithmwan@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 29, 2022 | Oct 13, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| The Percentage of Participants That Reported Little to no Intensity of Eye Dryness at Baseline and 2 Weeks of DT1fA Wear for End of Day (EOD) | Participants were asked to rate end of day dryness intensity (0 Never, 1 not intense to 5 Very Intense). Higher values indicate worse outcomes. | Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A) |
| The Percentage of Participants That Reported Little to no Noticeable Change Between Clear to Blurry or Foggy Vision at Baseline and 2 Weeks of DT1fA Wear for End of Day (EOD) | Participants were asked to rate noticeable change between clear to blurry or foggy vision (0 Never, 1 not intense to 5 Very Intense). Higher values indicate worse outcomes. | Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A) |
| Hours of Comfortable Wear | Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A) |
| Vision Stability | Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A) |
| Binocular Contact Lens Corrected Visual Acuity at Distance (6m) | Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A) |
| 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 |
|
Refit with delefilcon A for astigmatism
|
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| Other Pre-specified | The Percentage of Participants That Reported Little to no Intensity of Eye Discomfort at Baseline and 2 Weeks of DT1fA Wear for End of Day (EOD) | Participants were asked to rate end of day discomfort intensity (0 Never, 1 not intense to 5 Very Intense). Higher values indicate worse outcomes. | Percentage that reported little to no intensity of eye discomfort (responding 0, 1, or 2). | Posted | Count of Participants | Participants | Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A) |
|
|
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| Other Pre-specified | The Percentage of Participants That Reported Little to no Intensity of Eye Dryness at Baseline and 2 Weeks of DT1fA Wear for End of Day (EOD) | Participants were asked to rate end of day dryness intensity (0 Never, 1 not intense to 5 Very Intense). Higher values indicate worse outcomes. | Percentage that reported little to no intensity of dryness (responding 0, 1, or 2). | Posted | Count of Participants | Participants | Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A) |
|
|
|
| Other Pre-specified | The Percentage of Participants That Reported Little to no Noticeable Change Between Clear to Blurry or Foggy Vision at Baseline and 2 Weeks of DT1fA Wear for End of Day (EOD) | Participants were asked to rate noticeable change between clear to blurry or foggy vision (0 Never, 1 not intense to 5 Very Intense). Higher values indicate worse outcomes. | Percentage that reported little to no noticeable change between clear to blurry or foggy vision (responding 0, 1, or 2). | Posted | Count of Participants | Participants | Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A) |
|
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| Other Pre-specified | Hours of Comfortable Wear | Posted | Mean | Standard Deviation | hours | Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A) |
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|
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| Other Pre-specified | Vision Stability | Not Posted | Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A) | Participants |
| Other Pre-specified | Binocular Contact Lens Corrected Visual Acuity at Distance (6m) | Posted | Mean | Standard Deviation | logMAR | Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A) |
|
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| 0 |
| 85 |
| 0 |
| 85 |
| 0 |
| 85 |
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