Astigmatism
Conditions
Brief summary
To subjectively evaluate wearing experience in the T30fA lens among subjects who were already satisfied with their Biofinity Toric lenses.
Detailed description
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.
Interventions
DEVICEDailies Total1® contact lenses for astigmatism (T30fA)
Dailies Total1® contact lenses for astigmatism (T30fA)
Sponsors
Sengi
Scripps Poway Eyecare and Optometry
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Inclusion criteria
Subjects are eligible for the study if they meet the following criteria: Note: Ocular criteria must be met in both eyes. * Subjects who are currently wearing and can answer in the affirmative the following question: I am satisfied with my current Biofinity toric monthly replacement lenses prior to and after habitual lens optimization. * Subjects between the ages of 18-45 who wear their Biofinity Toric lenses at least 5 days per week, at least 10 hours per day. * Prescription with a sphere value between +4.00D and -6.00D inclusive, and a cylinder value between -0.75D and -2.25D. * Vision Correctable to 20/20 (0.0 logMAR) or better in each eye at 6M with their Manifest refraction. * Willing to attend all study visits.
Exclusion criteria
If any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction With Comfort of T30fA Lens | After 1 month of wear | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction With Ease of Handling of T30fA Lens | After 1 month of wear | 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. |
| Satisfaction Overall of Handling of T30fA Lens | After 1 month of wear | 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. |
| Satisfaction With Visual Performance of T30fA Lens | After 1 month of wear | 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. |
| Satisfaction With End of Day Comfort of T30fA Lens | After 1 month of wear | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Dailies Total1® Contact Lenses for Astigmatism (T30fA) | — |
|---|---|---|
| Age, Continuous | 29.2 years STANDARD_DEVIATION 5.6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 28 Participants | — |
| Sex: Female, Male Male | 12 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
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.
Time frame: After 1 month of wear
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dailies Total1® Contact Lenses for Astigmatism (T30fA) | Satisfaction With Comfort of T30fA Lens | 8 score on a scale |
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.
Time frame: After 1 month of wear
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dailies Total1® Contact Lenses for Astigmatism (T30fA) | Satisfaction Overall of Handling of T30fA Lens | 8 score on a scale |
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.
Time frame: After 1 month of wear
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dailies Total1® Contact Lenses for Astigmatism (T30fA) | Satisfaction With Ease of Handling of T30fA Lens | 9 score on a scale |
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.
Time frame: After 1 month of wear
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dailies Total1® Contact Lenses for Astigmatism (T30fA) | Satisfaction With End of Day Comfort of T30fA Lens | 7 score on a scale |
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.
Time frame: After 1 month of wear
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dailies Total1® Contact Lenses for Astigmatism (T30fA) | Satisfaction With Visual Performance of T30fA Lens | 8 score on a scale |