Evaluation of Wear Experience With Daily Contact Lenses

Contact Lens Clinical Trial

Official title:

Evaluation of Wear Experience With PRECISION1® Contact Lenses in Biofinity® Contact Lens Wearers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05096156
• Other study ID #: 2021H0118
• Status: Completed
• Phase: N/A
• Start date: May 28, 2021
• Est. completion date: December 17, 2021

Study information

• Verified date: November 2023
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the wear experience of current monthly replacement contact lens wearers after they have been fit into a daily disposable contact lens.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 17, 2021
• Est. primary completion date: November 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Currently wear Biofinity® monthly replacement spherical contact lenses.

• Distance visual acuity of 20/25 or better with current contact lenses.

• 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, which includes attending two study visits and wearing contact lenses on days between study visits.

Exclusion Criteria:

• No current ocular inflammation or infection.

• Not currently pregnant or lactating.

Related Conditions & MeSH terms

• Contact Lens

Intervention

Device:
• Precision1® Daily Disposable Contact Lens
Soft, spherical contact lens used to correct distance vision.

Locations

Country	Name	City	State
United States	The Ohio State University College of Optometry	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective Assessment of Precision1® Daily Disposable Contact Lens	Contact Lens Dry Eye Questionnaire (CLDEQ) survey (0-37, with higher scores related to higher symptoms)	2 weeks