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Clinical Trials/NCT04296877
NCT04296877CompletedNot Applicable

Evaluation of Wear Experience With PRECISION1® Contact Lenses in Previous Acuvue® Oasys® Lens Wearers

Ohio State University2 sites in 1 country30 target enrollmentStarted: March 10, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
2
Primary Endpoint
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Survey

Study Overview

Brief Summary

To evaluate the wear experience of current two-week contact lens wearers after they have been fit into a daily disposable contact lens. This is a single arm, non-comparative study.

Detailed Description

This is a single arm, non-comparative study. All participants were habitual lens wearers of the same brand of lenses, and were re-fit with the study lenses.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Must be current Acuvue® Oasys® spherical contact lens wearers.
  • 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.
  • Either gender.
  • Any racial or ethnic origin.

Exclusion Criteria

  • No current ocular inflammation or infection.
  • Not currently pregnant or lactating.

Outcomes

Primary Outcomes

Contact Lens Dry Eye Questionnaire (CLDEQ-8) Survey

Time Frame: 2 weeks

Participants complete the Contact Lens Dry Eye Questionnaire (CLDEQ-8) survey. This is an 8 question survey assesses symptoms while wearing contact lenses with possible scores from 0 (no symptoms) to 37 (maximum symptoms). Higher scores indicate worsening symptoms of dry eye while wearing lenses.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jennifer Fogt

Associate Professor Clinical

Ohio State University

Study Sites (2)

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