Clinical Comparison of Silicone Hydrogel Monthly Lenses

One-month Clinical Comparison of Silicone Hydrogel Monthly Lenses in High Lipid Depositors

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.

Study Overview

• Status: Completed
• Conditions: Refractive Error
• Intervention / Treatment: Device: Lotrafilcon B contact lenses; Device: Senofilcon C contact lenses

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW1E 6AU
    • Alcon Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Lotrafilcon B, then senofilcon C; 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.	Device: Lotrafilcon B contact lenses; Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking; Other Names: AIR OPTIX® plus HydraGlyde; Device: Senofilcon C contact lenses; Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking; Other Names: ACUVUE® VITA®
Other: Senofilcon C, then lotrafilcon B; 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.	Device: Lotrafilcon B contact lenses; Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking; Other Names: AIR OPTIX® plus HydraGlyde; Device: Senofilcon C contact lenses; Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking; Other Names: ACUVUE® VITA®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Manager, Medical Clinical Trial Services, Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2017
• Primary Completion (Actual): July 19, 2018
• Study Completion (Actual): July 19, 2018

Study Registration Dates

• First Submitted: May 25, 2017
• First Submitted That Met QC Criteria: May 25, 2017
• First Posted (Actual): May 30, 2017

Study Record Updates

• Last Update Posted (Actual): July 25, 2019
• Last Update Submitted That Met QC Criteria: May 23, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: lipids; contact lenses; deposits
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CLL541-P001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No