Myopia Clinical Trial
Official title:
Clinical Performance of Two Commercial, Daily Disposable Contact Lenses
Verified date | October 2022 |
Source | Alcon Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to compare the clinical performance of DAILIES TOTAL1 ( DT1) contact lenses with Infuse contact lenses.
Status | Completed |
Enrollment | 112 |
Est. completion date | October 12, 2021 |
Est. primary completion date | October 12, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Key Inclusion Criteria: - Habitually wears soft contact lenses in both eyes at least 5 days per week and at least 10 hours per day; - At least 3 months of contact lens wearing experience; - Less than or equal to 0.75 diopter (D) astigmatism in each eye; - Best Corrected Visual Acuity (BCVA) better than or equal to 20/25 in each eye. - Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: - Current/previous DAILIES TOTAL1 and/or Infuse habitual lens wearer; - Monovision and/or multifocal lens wearer; - Routinely sleeps in habitual contact lenses. - Other protocol-defined exclusion criteria may apply. |
Country | Name | City | State |
---|---|---|---|
United States | Alcon Investigator 3950 | Bloomington | Illinois |
United States | Alcon Investigator 6583 | Eden Prairie | Minnesota |
United States | Alcon Investigator 6614 | Franklin Park | Illinois |
United States | Alcon Investigator 2786 | Memphis | Tennessee |
United States | Alcon Investigator 6353 | Memphis | Tennessee |
United States | Alcon Investigator 6355 | Orlando | Florida |
United States | Alcon Investigator 6418 | Tallahassee | Florida |
United States | Alcon Investigator 3382 | Wyomissing | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Alcon Research |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Least Squares Mean Distance VA (logMAR) With Study Lenses | Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. | Day 8 (-0/+3), each study lens type |
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