Clinical Comparison of Silicone Hydrogel Monthly Lenses

Not Applicable

Completed

• Conditions: Refractive Error

• Registration Number: NCT03169153
• Lead Sponsor: Alcon Research

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-25
• Study First Submitted QC: 2017-05-25
• Study First Posted: 2017-05-30
• Study Start: 2017-09-22
• Primary Completion: 2018-07-19
• Study Completion: 2018-07-19
• Status Verified: 2019-05
• Results First Submitted: 2019-05-23
• Results First Submitted QC: 2019-05-23
• Last Update Submitted: 2019-05-23
• Results First Posted: 2019-07-25
• Last Update Posted: 2019-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Mean Ex-vivo Total Lipid Uptake (Total of Surface and Bulk Uptake) Per Lens	Day 30 after 10 hours of wear, each product	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.

Trial Locations

Locations (1)

Alcon Investigative Site; 🇬🇧 London, United Kingdom