Success of Dailies Total1 for Astigmatism Contact Lenses in Patients That Have Previously Failed With Toric Contact Lenses

Astigmatism Clinical Trial

Official title:

Success of Dailies Total1 for Astigmatism Contact Lenses in Patients That Have Previously Failed With Toric Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05886452
• Other study ID #: PB-23-02
• Status: Completed
• Start date: August 1, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: May 2024
• Source: Mann Eye Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Astigmatism

Intervention

Device:
• DT1fA contact lenses
Subjects will be fitted with DT1fA contact lenses

Locations

Country	Name	City	State
United States	Mann Eye Institute	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Mann Eye Institute	Sengi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).	After 30 days of DT1fA contact lens wear
Other	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).	After 30 days of DT1fA contact lens wear
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.	After 30 days of DT1fA contact lens wear