Evaluation of Wear Experience With Daily Contact Lenses

• Sponsor: Ohio State University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05096156
• Collaborator: Alcon Research (Industry)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 6.7
• Patients Per Site Per Month: 4.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Contact Lens	Device: Biofinity® Monthly Replacement Contact Lens; Device: Precision1® Daily Disposable Contact Lens	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of Wear Experience With PRECISION1® Contact Lenses in Biofinity® Contact Lens Wearers
• Actual Study Start Date: May 28, 2021
• Actual Primary Completion Date: Nov 17, 2021
• Actual Study Completion Date: Dec 17, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Habitual Contact Lens All subjects are re-fit into habitual Biofinity® brand contact lenses. Subjects are requested to wear the lenses for one week, for a minimum of at least 6 hours per day for 5 days.	Device: Biofinity® Monthly Replacement Contact Lens; Soft, spherical contact lens used to correct distance vision.
Active Comparator: Daily Disposable Contact Lens All subjects are fit into Precision1® contact lenses. Subjects are requested to wear the lenses for two weeks, for a minimum of at least 6 hours per day for 10 days.	Device: Precision1® Daily Disposable Contact Lens; Soft, spherical contact lens used to correct distance vision.

Outcome Measures

Primary Outcome Measures

1. Subjective Assessment of Precision1® Daily Disposable Contact Lens [3 weeks]

   Contact Lens Dry Eye Questionnaire (CLDEQ) survey

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ohio State University College of Optometry	Columbus	Ohio	United States	43210

Sponsors and Collaborators

• Ohio State University
• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ohio State University
• ClinicalTrials.gov Identifier: NCT05096156
• Other Study ID Numbers: 2021H0118
• First Posted: Oct 27, 2021
• Last Update Posted: Feb 18, 2022
• Last Verified: Feb 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

Study Results

No Results Posted as of Feb 18, 2022