Wear Experience With Daily Contact Lenses Over a Long Day

NCT04535310 — Not applicable, Completed, 35 participants, Ohio State University

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Evaluation of Wear Experience With PRECISION1® Contact Lenses on Long Lens-wear Days

Registry	NCT04535310
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	35 (Actual)
Sponsor	Ohio State University (Other); collaborators: Alcon Research
Conditions	Contact Lens
Interventions	Precision1® Daily Disposable Contact Lens (Device)
Dates	start 2020-10-13, primary completion 2020-12-08, completion 2021-03-31, first posted 2020-09-01, last updated 2023-02-08
Locations	1 site in United States

-Summary

This study is evaluating the wear experience of a daily contact lens after 10, 12, 14, and 16 hours of lens wear.

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+Arms and interventions

Arm	Type	Interventions	Description
Daily Disposable Contact Lens	Experimental	Device: Precision1® Daily Disposable Contact Lens	All subjects are fit into Precision1® contact lenses. Subjects are requested to wear the lenses for a total of two weeks.

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

+Outcome measures

Primary outcomes

Subjective Overall Comfort as Assessed Using the Visual Analog Scale (VAS) [Up to 14 days]: Subjective overall comfort as assessed using the Visual Analog Scale (VAS), with a scale of 0 to 100 with 0 being poor and 100 being excellent.

+Eligibility

Sex: All, ages: 18 Years to 40 Years, accepts healthy volunteers

Inclusion Criteria:

* Must be a current spherical contact lens wearer with longs days of lens wear.
* 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).
* Recent eye exam within the past year.
* Must have a working smart phone and be willing to download an app and/or receive and respond to texts.
* Ability to give informed consent.
* Willing to spend time for the study. Subjects will be required to attend three study visits, wear contact lenses on days between study visits, and must respond to push-notifications and/or texts on a smart phone for 5 days between visits 2 and 3.

Exclusion Criteria:

* No current ocular inflammation or infection as assessed by the study investigator.

+Posted results

Participant flow

Milestone	Daily Disposable Contact Lens
Started	35
Completed	35
Not completed	0

Outcome results

Subjective Overall Comfort as Assessed Using the Visual Analog Scale (VAS) (Primary), Median, units on a scale: Daily Disposable Contact Lens 93 (82.5 to 99)

Adverse events

Time frame: 2 months

Arm	Deaths	Serious adverse events	Other adverse events
Daily Disposable Contact Lens	0/35 (0.0%)	0/35 (0.0%)	0/35 (0.0%)

+Locations (1)

Facility	City	Country	Status
The Ohio State University College of Optometry	Columbus, Ohio	United States

+Study documents

Study Protocol and Statistical Analysis Plan (PDF, 2020-10-14)

+Investigators

Jennifer Fogt, OD, MS, Principal investigator, The Ohio State University College of Optometry