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

Astigmatism Bilateral Clinical Trial

Official title:

Evaluation of Wear Experience With Daily Disposable and Monthly Replacement Toric

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05580575
• Other study ID #: 2022H0270
• Status: Completed
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: March 9, 2023

Study information

• Verified date: April 2024
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: March 9, 2023
• Est. primary completion date: March 9, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Astigmatism
• Astigmatism Bilateral

Intervention

Device:
• Daily disposable toric soft contact lens
Daily disposable toric soft contact lens
• Monthly replacement toric daily wear soft contact lens
Monthly replacement toric daily wear soft contact lens

Locations

Country	Name	City	State
United States	The Ohio State University College of Optometry	Columbus	Ohio
United States	ProCare Vision Center	Granville	Ohio
United States	Complete Eye Care of Medina	Medina	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale Survey of Overall Comfort	Visual analog scale survey of comfort from 0 to 100, with 0 anchored as "poor" and 100 as "excellent"	1 month