Refractive Error Clinical Trial
Official title:
One-month Clinical Comparison of Silicone Hydrogel Monthly Lenses in High Lipid Depositors
Verified date | May 2019 |
Source | Alcon Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to compare AIR OPTIX® plus HydraGlyde (AOHG) contact lenses to ACUVUE® VITA® (VITA) contact lenses for total lipid uptake (total of surface and bulk uptake) after 30 days of wear by high lipid depositors.
Status | Completed |
Enrollment | 114 |
Est. completion date | July 19, 2018 |
Est. primary completion date | July 19, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Sign Informed Consent; - Best corrected visual acuity (BCVA) of at least 0.1 logarithm of the minimum angle of resolution (logMAR) in each eye at Visit 1; - Manifest cylinder less than or equal to 0.75 diopter (D) in each eye at Visit 1; - Successful current wearer (during the past 2 months for a minimum of 5 days per week and 8 hours per day) of monthly replacement silicone hydrogel lenses within the power range of lens powers available for the screening and study lenses; - Screening lenses worn 10 hours exhibiting high lipid uptake. Exclusion Criteria: - Habitual lens used in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week or more) during the past 2 months; - Habitually wearing AIR OPTIX AQUA, AIR OPTIX plus HydraGlyde, ACUVUE OASYS®, or ACUVUE VITA as contact lenses during the past 2 months; - Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current) - History of herpetic keratitis, corneal surgery, or irregular cornea; - Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator; - Abnormal ocular conditions or findings, as specified in the protocol; - Known pregnancy and lactation. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Alcon Investigative Site | London |
Lead Sponsor | Collaborator |
---|---|
Alcon Research |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean Ex-vivo Total Lipid Uptake (Total of Surface and Bulk Uptake) Per Lens | Contact lens was removed aseptically from the eye. Total lipid (fatty deposits) uptake, defined as total amount of lipids (surface and bulk) absorbed/adsorbed and extracted, was measured in micrograms. A lower value indicates better results. Only one lens from each subject contributed to the analysis. | Day 30 after 10 hours of wear, each product |
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