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OpenTrials
Completed

NCT Number: NCT02699684

Comparison of Lotrafilcon B Lenses With Different Packaging Solutions

The purpose of this study is to evaluate AIR OPTIX® plus HYDRAGLYDE® (AOHG) contact lenses compared to AIR OPTIX® AQUA (AOA) contact lenses in overall lens fit.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Subjects must not wear any contact lenses prior to the visit on Day 1 (Insertion) for Period 1 or Day 1 (Insertion) for Period 2.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Must sign Informed Consent Document;
  • Manifest cylinder less than or equal to 0.75 Diopter (D) in each eye;
  • Successful current wearer (during the past 2 months for a minimum of 5 days per week and 8 hours per day) of AOA contact lenses within the protocol-specified power range;
  • Willing to answer text messages on a daily basis during the study;
  • Willing to discontinue artificial tears and rewetting drops on the days of study visits;
  • Other protocol-specified inclusion criteria may apply.

Exclusion criteria

  • Habitual lens wear in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week);
  • 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;
  • Monocular (only 1 eye with functional vision) or fit with only 1 lens;
  • Pregnant or lactating;
  • Participation in any clinical study within 30 days of Visit 1;
  • Other protocol-specified exclusion criteria may apply.

Treatment and study plan

Lotrafilcon B contact lenses with EOBO-41

Device

Lotrafilcon B contact lenses packaged with copolymer 845 and EOBO-41

Other names: AIR OPTIX® plus HYDRAGLYDE®, AOHG

Lotrafilcon B contact lenses

Device

Lotrafilcon B contact lenses packaged with copolymer 845

Other names: AIR OPTIX® AQUA, AOA

Hydrogen peroxide-based lens care solution

Device

Commercially-available hydrogen peroxide-based lens care solution for cleaning, disinfecting, and storing silicone hydrogel soft contact lenses

Other names: AOSEPT® PLUS, CLEAR CARE® PLUS

Saline solution for rinsing contact lenses

Device

Commercially-available saline solution used as needed

Other names: Minims®

Saline solution for rinsing contact lens case

Device

Commercially-available solution used as needed

Other names: LENS PLUS® OCUPURE™

Primary outcomes

  1. Percentage of Subjects Satisfying the "no Re-fit" Criteria in Both Eyes

    Time frame: Day 30, each product

    Overall lens fit was graded by the Investigator on a 5-point scale: -2 (unacceptably tight); -1 (acceptably tight); 0 (optimal fit); +1 (acceptable loose); +2 (unacceptable loose). 'No re-fit' criteria was satisfied if an acceptable or optimal overall lens fit, that was also within one grade of the habitual lens fit value, was achieved.

Secondary outcomes

  1. Mean Ex Vivo Total Cholesterol Uptake After 30 Days of Wear

    Time frame: Day 30, each product

    The contact lens was removed from the eye. Cholesterol deposits were extracted and measured in micrograms (μg) per lens. Lower deposits indicate increased lens performance. Only one eye (right eye) contributed to the analysis.

  2. Change From Insertion in Minimum Protected Area (MPA)

    Time frame: Hour 0 (Lens Insertion) to Hour 12 on Day 1

    MPA (the minimum area of the contact lens surface (expressed in %) protected by the tear film between two natural blinks) was assessed by the Investigator during the interblink period using the Tearscope® lighting system. Higher values indicate a more stable tear film in front of the lens. This Outcome Measure was pre-specified for AOHG only. Both eyes contributed to the analysis.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

One Month Clinical Comparison of Two Lotrafilcon B Spherical Lenses With Different Packaging Solutions

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 4, 2016
Registry last updated
Jul 2, 2018

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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