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OpenTrials
Completed

NCT Number: NCT02495948

Comparison of Two Marketed Silicone Hydrogel Lenses

The purpose of this study is to evaluate cholesterol sorption by AIR OPTIX® AQUA lenses compared to ULTRA lenses after 30 days of wear.

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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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Sign informed consent document;
  • Vision correctable to 20/40 Snellen (feet) or better in each eye at distance with both study contact lenses;
  • Willing to wear study lenses on a daily basis (minimum 5 days/week, 8 hours/day) and attend all study visits;
  • Successful wear of single-vision spherical, 2-week/ monthly replacement silicone hydrogel contact lenses in both eyes daily wear during the past 2 months for a minimum of 5 days/week, 8 hours/day. (Note: Monovision is included);
  • Other protocol-specified inclusion criteria may apply.

Exclusion criteria

  • 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 within the past 30 days for which contact lens wear could be contraindicated as determined by the investigator;
  • Monocular (only 1 eye with functional vision) or fit with only one lens;
  • Current or past AIR OPTIX® AQUA or ULTRA lens wearers;
  • Other protocol-specified exclusion criteria may apply.

Treatment and study plan

Lotrafilcon B contact lenses

Device

Other names: AIR OPTIX® AQUA

Samfilcon A contact lenses

Device

Other names: Bausch + Lomb ULTRA

Hydrogen peroxide solution

Device

Used as a cleaning, disinfection, and storage solution for silicone hydrogel and soft contact lenses

Other names: CLEAR CARE®

Saline solution

Device

Used for rinsing contact lenses, as needed

Other names: SENSITIVE EYES® PLUS

Primary outcomes

  1. Mean Ex-vivo Cholesterol Deposits After 30 Days of Wear

    Time frame: Day 30, each product

    The contact lens (right eye) was removed and stored dry and frozen until analysis. Total cholesterol deposits (cholesterol and cholesterol esters) were extracted from the lens and measured in micrograms. Lower deposits indicate increased lens performance. Study originally intended to analyze 36 lenses per arm, but actual number of lenses analyzed was less due to measurement error.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

One Month Clinical Comparison of Lotrafilcon B and Samfilcon A

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 13, 2015
Registry last updated
Dec 28, 2016

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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