Refractive Errors Clinical Trial
Official title:
Clinical Comparison of Two Daily Wear Frequent Replacement Silicone Hydrogel Soft Contact Lenses
Verified date | May 2021 |
Source | Alcon Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objective of this study is to evaluate the overall performance of an investigational silicone hydrogel lens when compared to ACUVUE OASYS® with HYDRACLEAR® PLUS (AOHP).
Status | Completed |
Enrollment | 132 |
Est. completion date | May 4, 2021 |
Est. primary completion date | May 4, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Key Inclusion Criteria: - Sign an approved Informed Consent Form. - Wear spherical contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months. - Willing to wear habitual spectacles for vision correction when study lenses are not worn, as needed. - Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: - Any eye condition or use of medication that contraindicates contact lens wear, as determined by the Investigator. - History of refractive surgery or plan to have refractive surgery during the study. - Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear. - Routinely sleeps in contact lenses at least 1 night per week. - Part A: Current wearer of ACUVUE OASYS® with HYDRACLEAR® PLUS. - Part B: Current wearer of Biofinity family of contact lenses (comfilcon A). - Other protocol-defined exclusion criteria may apply. |
Country | Name | City | State |
---|---|---|---|
United States | Alcon Investigator 6356 | Longwood | Florida |
United States | Alcon Investigator 6565 | Maitland | Florida |
United States | Alcon Investigator 6353 | Memphis | Tennessee |
United States | Alcon Investigator 6401 | Warwick | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Alcon Research |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Distance Visual Acuity (VA) (Part A) | Distance 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. No formal hypothesis testing was predefined for the primary endpoint. The primary endpoint was prespecified for Part A only. | Day 30, each study lens type |
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