N/A
Completed N=81
Clinical Comparison of Silicone Hydrogel Monthly Lenses
Refractive Error
Source: ClinicalTrials.gov NCT03169153 ↗
Enrolled (actual)
81
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcomePrimary: Mean Ex-vivo Total Lipid Uptake (Total of Surface and Bulk Uptake) Per Lens — 78.1398; 307.6800 micrograms (μg) — p=<0.0001
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Ex-vivo Total Lipid Uptake (Total of Surface and Bulk Uptake) Per Lens |
78.1398; 307.6800 | <0.0001 sig |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03169153). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.