Status:

COMPLETED

Clinical Assessment of a Daily Disposable Soft Silicone Hydrogel Contact Lens

Lead Sponsor:

Alcon Research

Conditions:

Refractive Errors

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The purpose of this study is to assess the clinical performance of DAILIES TOTAL1® spherical soft contact lenses over approximately 1 week of daily wear.

Detailed Description

Subjects will be expected to attend 2 visits (Visit 1 Screen/Baseline/ Dispense; and Visit 2 Week 1 Follow-up/ Exit). The total duration of a subject's participation in the study as well as exposure t...

Eligibility Criteria

Inclusion

  • Key
  • Current wearer of commercial spherical soft contact lenses in both eyes with at least 3 months of wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day;
  • Manifest cylinder less than or equal to 0.75 diopter (D) in each eye;
  • Best corrected distance visual acuity better than or equal to 20/25 (Snellen) in each eye.
  • Key

Exclusion

  • Current or prior habitual DAILIES TOTAL1 soft contact lens wear in the past 3 months prior to consent;
  • Monovision contact lens wear;
  • Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.

Key Trial Info

Start Date :

October 13 2023

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 8 2023

Estimated Enrollment :

97 Patients enrolled

Trial Details

Trial ID

NCT06044948

Start Date

October 13 2023

End Date

November 8 2023

Last Update

November 20 2024

Active Locations (6)

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Page 1 of 2 (6 locations)

1

Tallahassee Eye Center

Tallahassee, Florida, United States, 32308

2

The Eye Doctors, Inc.

Eden Prairie, Minnesota, United States, 55344

3

Oculus Research, Inc.

Garner, North Carolina, United States, 27529

4

ProCare Vision Center

Granville, Ohio, United States, 43023