Clinical Comparison of Silicone Hydrogel Monthly Lenses

Not Applicable

Completed

Conditions: Refractive Error

Interventions: Device: Lotrafilcon B contact lenses
Device: Senofilcon C contact lenses

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

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

Arm && Interventions

Group	Intervention	Description
Senofilcon C, then lotrafilcon B	Lotrafilcon B contact lenses	Senofilcon C contact lenses worn first, followed by lotrafilcon B contact lenses, as randomized. Each product worn bilaterally (in both eyes) for a total duration of 30 (+ 3) days under a daily wear modality for the specific study period. The lenses will be removed every night and cared for with the subject's habitual lens care solution.
Lotrafilcon B, then senofilcon C	Lotrafilcon B contact lenses	Lotrafilcon B contact lenses worn first, followed by senofilcon C contact lenses, as randomized. Each product worn bilaterally (in both eyes) for a total duration of 30 (+ 3) days under a daily wear modality for the specific study period. The lenses will be removed every night and cared for with the subject's habitual lens care solution.
Lotrafilcon B, then senofilcon C	Senofilcon C contact lenses	Lotrafilcon B contact lenses worn first, followed by senofilcon C contact lenses, as randomized. Each product worn bilaterally (in both eyes) for a total duration of 30 (+ 3) days under a daily wear modality for the specific study period. The lenses will be removed every night and cared for with the subject's habitual lens care solution.
Senofilcon C, then lotrafilcon B	Senofilcon C contact lenses	Senofilcon C contact lenses worn first, followed by lotrafilcon B contact lenses, as randomized. Each product worn bilaterally (in both eyes) for a total duration of 30 (+ 3) days under a daily wear modality for the specific study period. The lenses will be removed every night and cared for with the subject's habitual lens care solution.

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.

Secondary Outcome Measures