Evaluation of Wear Experience With Daily Disposable and Monthly Replacement Toric Contact Lenses

April 24, 2024 updated by: Jennifer Fogt, Ohio State University

Evaluation of Wear Experience With Daily Disposable and Monthly Replacement Toric

Comparison of wear experience with daily disposable and monthly replacement soft contact lenses in contact lens wearers who have astigmatism.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Medina, Minnesota, United States, 55340
        • Complete Eye Care of Medina
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University College of Optometry
      • Granville, Ohio, United States, 43023
        • ProCare Vision Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Subjects must be current soft lens wearers in both eyes.
  • Subjects must have 20/25 or better distance visual acuity with current lenses (entering acuity).
  • Good general health (defined by 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 to spend time for the study. Subjects will be required to attend two study visits and wear contact lenses on days between study visits.
  • Either gender
  • Any racial or ethnic origin

Exclusion Criteria:

  • Participants cannot be pregnant or lactating.
  • Participants cannot be current wearers of the study lenses
  • No current ocular inflammation or infection as assessed by the study investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Daily disposable lens worn first, reusable lens worn second
Subject will wear each contact lenses for 30 days during the day only.
Device: Daily disposable toric soft contact lens
Daily disposable toric soft contact lens
Device: Monthly replacement toric daily wear soft contact lens
Monthly replacement toric daily wear soft contact lens
Experimental: Reusable lens worn first, daily disposable lens worn second
Subject will wear each contact lenses for 30 days during the day only.
Device: Daily disposable toric soft contact lens
Daily disposable toric soft contact lens
Device: Monthly replacement toric daily wear soft contact lens
Monthly replacement toric daily wear soft contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale Survey of Overall Comfort
Time Frame: 1 month
Visual analog scale survey of comfort from 0 to 100, with 0 anchored as "poor" and 100 as "excellent"
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Actual)

March 9, 2023

Study Completion (Actual)

March 9, 2023

Study Registration Dates

First Submitted

October 12, 2022

First Submitted That Met QC Criteria

October 13, 2022

First Posted (Actual)

October 14, 2022

Study Record Updates

Last Update Posted (Actual)

April 29, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022H0270

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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