Comparison of Lotrafilcon B Lenses With Different Packaging Solutions

May 31, 2018 updated by: Alcon Research

One Month Clinical Comparison of Two Lotrafilcon B Spherical 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: AOHG, then AOA
Lotrafilcon B contact lenses with EOBO-41 worn first, followed by lotrafilcon B contact lenses worn second. Both products worn bilaterally (in both eyes) for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution.
Device: Lotrafilcon B contact lenses with EOBO-41
Lotrafilcon B contact lenses packaged with copolymer 845 and EOBO-41
Other Names:
  • AIR OPTIX® plus HYDRAGLYDE®
  • AOHG
Device: Lotrafilcon B contact lenses
Lotrafilcon B contact lenses packaged with copolymer 845
Other Names:
  • AOA
  • AIR OPTIX® AQUA
Device: Hydrogen peroxide-based lens care solution
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
Device: Saline solution for rinsing contact lenses
Commercially-available saline solution used as needed
Other Names:
  • Minims®
Device: Saline solution for rinsing contact lens case
Commercially-available solution used as needed
Other Names:
  • LENS PLUS® OCUPURE™
Other: AOA, then AOHG
Lotrafilcon B contact lenses worn first, followed by lotrafilcon B contact lenses with EOBO-41 worn second. Both products worn bilaterally for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution.
Device: Lotrafilcon B contact lenses with EOBO-41
Lotrafilcon B contact lenses packaged with copolymer 845 and EOBO-41
Other Names:
  • AIR OPTIX® plus HYDRAGLYDE®
  • AOHG
Device: Lotrafilcon B contact lenses
Lotrafilcon B contact lenses packaged with copolymer 845
Other Names:
  • AOA
  • AIR OPTIX® AQUA
Device: Hydrogen peroxide-based lens care solution
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
Device: Saline solution for rinsing contact lenses
Commercially-available saline solution used as needed
Other Names:
  • Minims®
Device: Saline solution for rinsing contact lens case
Commercially-available solution used as needed
Other Names:
  • LENS PLUS® OCUPURE™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 30, each product

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 30, each product
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.
Hour 0 (Lens Insertion) to Hour 12 on Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Investigators

  • Study Director: Clinical Trial Manager, EMEA, Alcon, A Novartis Division

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2016

Primary Completion (Actual)

October 20, 2016

Study Completion (Actual)

October 20, 2016

Study Registration Dates

First Submitted

March 1, 2016

First Submitted That Met QC Criteria

March 1, 2016

First Posted (Estimate)

March 4, 2016

Study Record Updates

Last Update Posted (Actual)

July 2, 2018

Last Update Submitted That Met QC Criteria

May 31, 2018

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLE270-P001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Refractive Error

Clinical Trials on Lotrafilcon B contact lenses with EOBO-41

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe