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

NCT05886452 | Completed Results FDA Device

• 1 other identifier: PB-23-02
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (2)

• 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

• Percentage of Patients Reporting a Desire to Remain in DT1fA Lenses After Study is Concluded.

  After 30 days of DT1fA contact lens wear

Study Arms (1)

DT1fA contact lenses

Subjects fitted with DT1fA contact lenses

Device: DT1fA contact lenses

Interventions

DT1fA contact lenses DEVICE

Subjects will be fitted with DT1fA contact lenses

DT1fA contact lenses

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mann Eye Institute: lead
• Sengi: collaborator

Study Sites (1)

Mann Eye Institute

Houston, Texas, 76134-2099, United States

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Dr Phillip Brunson
• Organization: Mann Eye Institute

Phillip.Brunson@manneye.com

17135802500

Study Officials

• Phillip Brunson, OD

  Mann Eye Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 2, 2023
• Study Start: August 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: March 25, 2025
• Results First Posted: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)