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

NCT ID: NCT05886452

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 65 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-04-01

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

Conditions

Astigmatism

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

DT1fA contact lenses

Subjects fitted with DT1fA contact lenses

DT1fA contact lenses

Intervention Type: DEVICE

Subjects will be fitted with DT1fA contact lenses

Interventions

DT1fA contact lenses

Subjects will be fitted with DT1fA contact lenses

Intervention Type: DEVICE

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sengi

INDUSTRY

Sponsor Role: collaborator

Mann Eye Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Phillip Brunson, OD

Role: PRINCIPAL_INVESTIGATOR

Mann Eye Institute

Locations

Mann Eye Institute

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PB-23-02

Identifier Type: -

Identifier Source: org_study_id