Dry Eye Clinical Trial
Official title:
Do Total 30 Sphere Contact Lenses Provide a Comfortable Wearing Experience All Day?
Verified date | November 2022 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to map comfort over the full wear day in established, asymptomatic, soft CL wearers who are refit in Total30 Sphere CLs.
Status | Completed |
Enrollment | 48 |
Est. completion date | July 20, 2022 |
Est. primary completion date | July 20, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - Current contact lens wearers who have 20/20 visual acuity or better - Minimally symptomatic as based upon Contact Lens Dry Eye Questionnaire scores (=10) - Astigmatism better than or equal to 0.50 D in each eye - Must have regularly worn 2 week or monthly contact lenses within the past 6 months - Must provide a glasses prescription that is is less than 3 years old - Willing to start wearing their contact lenses between 6:00 AM and 8:00 AM and wear their contact lenses until 11:00 PM each day Exclusion Criteria: - Past or Current hard CL use - Any known systemic health conditions that are thought to alter tear film physiology - History of viral eye disease - History of ocular surgery - History of severe ocular trauma - Active ocular infection or inflammation - Currently using isotretinoin-derivatives - Currently using ocular medications - Currently using rewetting drops or artificial tear - Pregnant or breast feeding |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham | Alcon Research |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual Analog Scale (VAS) Ocular Comfort | A visual analog scale (VAS) was used to compare end of day ocular comfort at 16 hours of contact lens wear over the 1 month study (0 to 100 scale with 100 being best). | 1 month |
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