Evaluation of Wear Experience With Daily Contact Lenses
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 28, 2021
CompletedFirst Submitted
Initial submission to the registry
October 19, 2021
CompletedFirst Posted
Study publicly available on registry
October 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 17, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 17, 2021
CompletedResults Posted
Study results publicly available
November 8, 2023
CompletedNovember 8, 2023
November 1, 2023
6 months
October 19, 2021
September 27, 2023
November 6, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
All participants are fit with the study daily disposable lenses
EXPERIMENTALAll subjects are re-fit into their habitual monthly replacement 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. Upon return, subjects are refit into the daily disposable contact lenses.
Interventions
Soft, spherical contact lens used to correct distance vision.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- No current ocular inflammation or infection.
- Not currently pregnant or lactating.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ohio State Universitylead
- Alcon Researchcollaborator
Study Sites (1)
The Ohio State University College of Optometry
Columbus, Ohio, 43210, United States
Results Point of Contact
- Title
- Dr. Jennifer Fogt, OD MS, Principal Investigator
- Organization
- The Ohio State University College of Optometry
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
October 19, 2021
First Posted
October 27, 2021
Study Start
May 28, 2021
Primary Completion
November 17, 2021
Study Completion
December 17, 2021
Last Updated
November 8, 2023
Results First Posted
November 8, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share