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OpenTrials
Completed

NCT Number: NCT03169153

Clinical Comparison of Silicone Hydrogel Monthly Lenses

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.

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Key information

Conditions

Refractive Error Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alcon Investigative Site

London, SW1E 6AU, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lotrafilcon B contact lenses

Device

Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking

Other names: AIR OPTIX® plus HydraGlyde

Senofilcon C contact lenses

Device

Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking

Other names: ACUVUE® VITA®

Primary outcomes

  1. Mean Ex-vivo Total Lipid Uptake (Total of Surface and Bulk Uptake) Per Lens

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 30, 2017
Registry last updated
Jul 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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