An interventional study of Daily Disposable Contact Lens in Contact Lens, sponsored by Ohio State University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-07.
Sponsored by Ohio State University · Not applicable, Interventional, and Treatment
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.
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.
Ohio State University is the lead sponsor of 661 studies on the registry; 148 are open to participants now.
Of its 66 completed or terminated interventional studies of FDA-regulated products, 49 (74%) have results posted.
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Exclusion Criteria:
All subjects are fit into daily disposable contact lenses after wearing their optimized habitual contact lenses for \~ 1 week. Subjects are requested to wear the lenses for two weeks, for a minimum of at least 6 hours per day for 10 days.
Device: Daily Disposable Contact Lens
Soft, daily disposable spherical contact lens used to correct distance vision.
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Survey
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.
Time frame: 2 weeks
| Milestone | Single Arm Study |
|---|---|
| Started | 30 |
| Completed | 30 |
| Not completed | 0 |
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.
| units on a scale | All Study Participants |
|---|---|
| Contact Lens Dry Eye Questionnaire (CLDEQ-8) Survey | 9.5 (6 to 17.75) |
Collected over 4 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Study Participants | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
Participants
| Age, Categorical(Participants) | All Participants Wear Study Daily Disposable Contact Lenses |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 30 |
| >=65 years | 0 |
| Age, Continuous(years) | All Participants Wear Study Daily Disposable Contact Lenses |
|---|---|
| Mean | 29.1 ± 7.8 |
| Sex: Female, Male(Participants) | All Participants Wear Study Daily Disposable Contact Lenses |
|---|---|
| Female | 19 |
| Male | 11 |
| Race (NIH/OMB)(Participants) | All Participants Wear Study Daily Disposable Contact Lenses |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 3 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 25 |
| More than one race | 2 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | All Participants Wear Study Daily Disposable Contact Lenses |
|---|---|
| United States | 30 |
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Plan to share: No
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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