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

Sponsor
Ohio State University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05580575
Collaborator
(none)
75
Enrollment
3
Locations
2
Arms
3.9
Anticipated Duration (Months)
25
Patients Per Site
6.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Daily disposable toric soft contact lens
  • Device: Monthly replacement toric daily wear soft contact lens
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Evaluation of Wear Experience With Daily Disposable and Monthly Replacement Toric
Actual Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Jan 31, 2023
Anticipated Study Completion Date :
Feb 28, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: First lens wear experience

Subject will wear 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: Second lens wear experience

Subject will wear 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

Outcome Measures

Primary Outcome Measures

  1. Visual analog scale survey of overall comfort [1 month]

    Visual analog scale survey of comfort from 0 to 100, with 0 anchored as "poor" and 100 as "excellent"

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Complete Eye Care of Medina Medina Minnesota United States 55340
2 The Ohio State University College of Optometry Columbus Ohio United States 43210
3 ProCare Vision Center Granville Ohio United States 43023

Sponsors and Collaborators

  • Ohio State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jennifer Fogt, PI, Ohio State University
ClinicalTrials.gov Identifier:
NCT05580575
Other Study ID Numbers:
  • 2022H0270
First Posted:
Oct 14, 2022
Last Update Posted:
Dec 20, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Jennifer Fogt, PI, Ohio State University
contact lenses
astigmatism
Additional relevant MeSH terms:
Astigmatism

Study Results

No Results Posted as of Dec 20, 2022