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Total30 Sphere Contact Lenses

NCT ID: NCT05183022

Last Updated: 2022-12-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-03

Study Completion Date

2022-07-20

Brief Summary

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The purpose of this study is to map comfort over the full wear day in established, asymptomatic, soft CL wearers who are refit in Total30 Sphere CLs.

Detailed Description

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Contact lens (CL) wearers frequently face eye discomfort symptoms, especially towards the end of the wear day. This burdensome discomfort can unfortunately cause patients to remove their CLs before their desired wear time. While comfortable wear times vary from patient to patient, Terry et al. has suggested that patients should be able to comfortably wear their CLs for at least 12 hours per day for at least 6 days per week. Nevertheless, the literature currently lacks sufficient data to comment fully on the full day wear experience, which for many patients may be 16 or more hours per day, especially if they have demanding careers. One CL that has the potential to allow for all day comfort is the Total30 Sphere CLs, which is a new water gradient, monthly CL aimed at delivering all day comfort and visual performance. Thus, the purpose of this study is to map comfort over the full wear day in established, asymptomatic, soft CL wearers who are refit in Total30 Sphere CLs. These data are not only important for judging the performance of Total30 Sphere CLs, but they will provide some of the first insights into the full day CL wearing experience over one month.

Conditions

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Contact Lens Complication Dry Eye

Keywords

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Total30 Sphere Contact Lenses; Comfort; Dryness; Visual Analog Scale Scores

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This prospective, one-month, three-visit study will refit all participants into Total30 Sphere contact lenses.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Total30 Sphere Contact Lenses

All qualified participants will be refit into Total30 Sphere contact lenses.

Group Type EXPERIMENTAL

Total30 Sphere Contact Lenses

Intervention Type DEVICE

Participants will be refit into Total30 Sphere contact lenses and followed for 1 month.

Interventions

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Total30 Sphere Contact Lenses

Participants will be refit into Total30 Sphere contact lenses and followed for 1 month.

Intervention Type DEVICE

Other Intervention Names

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Lehfilcon A

Eligibility Criteria

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Inclusion Criteria

* Current contact lens wearers who have 20/20 visual acuity or better
* Minimally symptomatic as based upon Contact Lens Dry Eye Questionnaire scores (≤10)
* Astigmatism better than or equal to 0.50 D in each eye
* Must have regularly worn 2 week or monthly contact lenses within the past 6 months
* Must provide a glasses prescription that is is less than 3 years old
* Willing to start wearing their contact lenses between 6:00 AM and 8:00 AM and wear their contact lenses until 11:00 PM each day

Exclusion Criteria

* Past or Current hard CL use
* Any known systemic health conditions that are thought to alter tear film physiology
* History of viral eye disease
* History of ocular surgery
* History of severe ocular trauma
* Active ocular infection or inflammation
* Currently using isotretinoin-derivatives
* Currently using ocular medications
* Currently using rewetting drops or artificial tear
* Pregnant or breast feeding
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Andrew Pucker

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrew D Pucker, OD, MS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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IRB-300008004

Identifier Type: -

Identifier Source: org_study_id