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| Name | Class |
|---|---|
| Sengi | INDUSTRY |
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The objective is to determine the percentages of past toric CL wearers (who dropped out of contact lens wear due to dissatisfaction with comfort or vision) who are satisfied with the comfort and vision of DT1fA contact lenses.
This is a single arm, prospective, non-comparative, open-label post market clinical study of satisfaction of past toric CL wearers, with DT1fA contact lenses. Subjects will be assessed at a screening visit, and 2 follow-up visits. Clinical evaluations will include measurement of visual acuity, manifest refraction, and administration a questionnaire
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DT1fA contact lenses | Subjects fitted with DT1fA contact lenses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DT1fA contact lenses | Device | Subjects will be fitted with DT1fA contact lenses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Positive Ratings (>50 Out of 100) for Satisfaction of Comfort and Vision. | A questionnaire will be administered. Subjects are asked to rate their satisfaction with comfort and vision on a scale of 0 to 100, with higher ratings indicating higher satisfaction with comfort and vision. | After 30 days of DT1fA contact lens wear |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Reporting Satisfaction of Overall and End of Day (EOD) Comfort and Vision; Comfort and Vision Under Real-world Conditions Related to Computer (or Tablet) Usage and Cellphone Usage. | A questionnaire will be administered. Subjects are asked to rate their satisfaction with end of day comfort and vision on a Likert scale (Strongly Disagree, Disagree, Neither Disagree nor Agree, Agree, Strongly Agree). Satisfaction was determined as subjects answering "Agree" or "Strongly Agree". |
Inclusion Criteria:
Subjects are eligible for the study if they meet the following criteria:
Note: Ocular criteria must be met in both eyes.
Gender: Males and Females.
Subjects will be 18-39 years old.
History of previous unsuccessful astigmatism contact lens wearer with qualifying answer to screening questions:
I used to wear astigmatism correcting (toric) soft contact lenses.
- (YES)
I stopped wearing my previous astigmatism correcting soft contact lenses because of one or more of the below reasons:
Subjects must have 20/25 or better distance visual acuity in each eye with current best correction.
Good general health (defined by prescription medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI).
Ability to give informed consent.
Willing and able to spend time for the study (Subjects will be required to attend three study visits and wear contact lenses on days between study visits).
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 test subjects will be 18 to 39 years of age with history of previous unsuccessful astigmatism contact lens wear.
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| Name | Affiliation | Role |
|---|---|---|
| Phillip Brunson, OD | Mann Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mann Eye Institute | Houston | Texas | 76134-2099 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | DT1fA Contact Lenses | Subjects fitted with DT1fA contact lenses DT1fA contact lenses: Subjects will be fitted with DT1fA contact lenses |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DT1fA Contact Lenses | Subjects fitted with DT1fA contact lenses DT1fA contact lenses: Subjects will be fitted with 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 | Percentage of Patients With Positive Ratings (>50 Out of 100) for Satisfaction of Comfort and Vision. | A questionnaire will be administered. Subjects are asked to rate their satisfaction with comfort and vision on a scale of 0 to 100, with higher ratings indicating higher satisfaction with comfort and vision. | Posted | Count of Participants | Participants | After 30 days of DT1fA contact lens wear |
|
|
3 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 | DT1fA Contact Lenses | Subjects fitted with DT1fA contact lenses DT1fA contact lenses: Subjects will be fitted with DT1fA contact lenses |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Phillip Brunson | Mann Eye Institute | 17135802500 | Phillip.Brunson@manneye.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 | May 17, 2023 | Mar 4, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| After 30 days of DT1fA contact lens wear |
| Percentage of Patients Reporting a Desire to Remain in DT1fA Lenses After Study is Concluded. | A questionnaire will be administered. Subjects are asked to rate their desire to remain in DT1fA contact lenses a Likert scale (Strongly Disagree, Disagree, Neither Disagree nor Agree, Agree, Strongly Agree). Desire to remain was determined as subjects answering "Agree" or "Strongly Agree". | After 30 days of DT1fA contact lens 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 | Percentage of Patients Reporting Satisfaction of Overall and End of Day (EOD) Comfort and Vision; Comfort and Vision Under Real-world Conditions Related to Computer (or Tablet) Usage and Cellphone Usage. | A questionnaire will be administered. Subjects are asked to rate their satisfaction with end of day comfort and vision on a Likert scale (Strongly Disagree, Disagree, Neither Disagree nor Agree, Agree, Strongly Agree). Satisfaction was determined as subjects answering "Agree" or "Strongly Agree". | Posted | Count of Participants | Participants | After 30 days of DT1fA contact lens wear |
|
|
|
| Other Pre-specified | Percentage of Patients Reporting a Desire to Remain in DT1fA Lenses After Study is Concluded. | A questionnaire will be administered. Subjects are asked to rate their desire to remain in DT1fA contact lenses a Likert scale (Strongly Disagree, Disagree, Neither Disagree nor Agree, Agree, Strongly Agree). Desire to remain was determined as subjects answering "Agree" or "Strongly Agree". | Posted | Count of Participants | Participants | After 30 days of DT1fA contact lens wear |
|
|
|
| 0 |
| 65 |
| 0 |
| 65 |
| 0 |
| 65 |
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