Clinical trial NCT05886452: Success of Dailies Total1 for Astigmatism Contact Lenses in Patients That Have Previously Failed With Toric Contact Lenses
Official title: Success of Dailies Total1 for Astigmatism Contact Lenses in Patients That Have Previously Failed With Toric Contact Lenses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Astigmatism
Lead sponsor: Mann Eye Institute
Sponsor class: OTHER
Collaborators: name: Sengi
First posted: 2023-06-02
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible test subjects will be 18 to 39 years of age with history of previous unsuccessful astigmatism contact lens wear.

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

Eligibility criteria: 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 exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

* Previous ocular surgery.
* Inability to be fit with the DT1fA lens design.
* Subjects that should be wearing a toric contact lens for best acuity but have chosen to continue in spherical contact lens wear.
* History of Accutane use.
* Ocular surface disease that in the investigator's opinion would interfere with contact lens wear.
* History of comorbidities, including autoimmune disorders and diabetes.
* Irregular astigmatism as identified by Pentacam.
* History of Amblyopia.
* History of Strabismus and/or history of eye muscle surgery.
* History of Monovision.
* Potential subjects who are pregnant.

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.

Primary outcomes:
measure: Percentage of Patients With Positive Ratings (>50 Out of 100) for Satisfaction of Comfort and Vision.
timeFrame: After 30 days of DT1fA contact lens wear
Secondary outcomes:
Other outcomes:
measure: 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.
timeFrame: After 30 days of DT1fA contact lens wear
measure: Percentage of Patients Reporting a Desire to Remain in DT1fA Lenses After Study is Concluded.
timeFrame: After 30 days of DT1fA contact lens wear
Locations:
city: Houston
country: United States
facility: Mann Eye Institute
state: Texas
Study officials:
affiliation: Mann Eye Institute
name: Phillip Brunson, OD
role: PRINCIPAL_INVESTIGATOR
References: