Comparison of Two Marketed Silicone Hydrogel Lenses

November 7, 2016 updated by: Alcon Research

One Month Clinical Comparison of Lotrafilcon B and Samfilcon A

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

168

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: AOA then ULTRA
Lotrafilcon B contact lenses worn first, followed by samfilcon A contact lenses. Each product worn bilaterally (in both eyes) for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.
Device: Lotrafilcon B contact lenses
Other Names:
  • AIR OPTIX® AQUA
Device: Samfilcon A contact lenses
Other Names:
  • Bausch + Lomb ULTRA
Device: Hydrogen peroxide solution
Used as a cleaning, disinfection, and storage solution for silicone hydrogel and soft contact lenses
Other Names:
  • CLEAR CARE®
Device: Saline solution
Used for rinsing contact lenses, as needed
Other Names:
  • SENSITIVE EYES® PLUS
Other: ULTRA then AOA
Samfilcon A contact lenses worn first, followed by lotrafilcon B contact lenses. Each product worn bilaterally for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.
Device: Lotrafilcon B contact lenses
Other Names:
  • AIR OPTIX® AQUA
Device: Samfilcon A contact lenses
Other Names:
  • Bausch + Lomb ULTRA
Device: Hydrogen peroxide solution
Used as a cleaning, disinfection, and storage solution for silicone hydrogel and soft contact lenses
Other Names:
  • CLEAR CARE®
Device: Saline solution
Used for rinsing contact lenses, as needed
Other Names:
  • SENSITIVE EYES® PLUS

What is the study measuring?

Primary Outcome Measures

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

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, Vision Care, GCRA, 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

July 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

July 9, 2015

First Submitted That Met QC Criteria

July 9, 2015

First Posted (Estimate)

July 13, 2015

Study Record Updates

Last Update Posted (Estimate)

December 28, 2016

Last Update Submitted That Met QC Criteria

November 7, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLA560-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.

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