Clinical Comparison of Silicone Hydrogel Monthly Lenses

Alcon

Status: Completed

Conditions: Refractive Error

Treatments: Device: Senofilcon C contact lenses; Device: Lotrafilcon B contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT03169153

CLL541-P001

Details and patient eligibility

About

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.

Enrollment: 114 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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114 participants in 2 patient groups

Lotrafilcon B, then senofilcon C

Other group

Description:

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.

Treatment:

Device: Lotrafilcon B contact lenses

Device: Senofilcon C contact lenses

Senofilcon C, then lotrafilcon B

Other group

Description:

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.

Treatment:

Device: Lotrafilcon B contact lenses

Device: Senofilcon C contact lenses