Astigmatism
Conditions
Brief summary
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.
Detailed description
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
Interventions
DEVICEDT1fA contact lenses
Subjects will be fitted with DT1fA contact lenses
Sponsors
Sengi
Mann Eye Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
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: * Poor or fluctuating vision * Discomfort * Other * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Positive Ratings (>50 Out of 100) for Satisfaction of Comfort and Vision. | After 30 days of DT1fA contact lens wear | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Reporting a Desire to Remain in DT1fA Lenses After Study is Concluded. | After 30 days of DT1fA contact lens wear | 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. |
| 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. | After 30 days of DT1fA contact lens wear | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DT1fA Contact Lenses Subjects fitted with DT1fA contact lenses
DT1fA contact lenses: Subjects will be fitted with DT1fA contact lenses | 65 |
| Total | 65 |
Baseline characteristics
| Characteristic | DT1fA Contact Lenses | — |
|---|---|---|
| Age, Continuous | 29.5 years STANDARD_DEVIATION 5 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 50 Participants | — |
| Sex: Female, Male Male | 15 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 65 |
| other Total, other adverse events | 0 / 65 |
| serious Total, serious adverse events | 0 / 65 |
Outcome results
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.
Time frame: After 30 days of DT1fA contact lens wear
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DT1fA Contact Lenses | Percentage of Patients With Positive Ratings (>50 Out of 100) for Satisfaction of Comfort and Vision. | 57 Participants |
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.
Time frame: After 30 days of DT1fA contact lens wear
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DT1fA Contact Lenses | Percentage of Patients Reporting a Desire to Remain in DT1fA Lenses After Study is Concluded. | 38 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.
Time frame: After 30 days of DT1fA contact lens wear
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DT1fA Contact Lenses | 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. | 36 Participants |