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Comparison of Two Marketed Silicone Hydrogel Lenses

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT02495948
Collaborator
(none)
168
Enrollment
2
Arms
3
Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Lotrafilcon B contact lenses
  • Device: Samfilcon A contact lenses
  • Device: Hydrogen peroxide solution
  • Device: Saline solution
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
168 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Official Title:
One Month Clinical Comparison of Lotrafilcon B and Samfilcon A
Study Start Date :
Jul 1, 2015
Actual Primary Completion Date :
Oct 1, 2015
Actual Study Completion Date :
Oct 1, 2015

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Alcon Research

    Investigators

    • Study Director: Clinical Trial Manager, Vision Care, GCRA, Alcon, A Novartis Division

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT02495948
    Other Study ID Numbers:
    • CLA560-P001
    First Posted:
    Jul 13, 2015
    Last Update Posted:
    Dec 28, 2016
    Last Verified:
    Nov 1, 2016
    Additional relevant MeSH terms:
    Refractive Errors
    Hydrogen Peroxide
    Pharmaceutical Solutions

    Study Results

    Participant Flow

    Recruitment Details Participants were recruited from 10 investigational sites located in the US.
    Pre-assignment Detail Of the 168 enrolled, 1 participant was exited as a screen failure prior to randomization. This reporting group includes all randomized participants (167).
    Arm/Group Title AOA Then ULTRA ULTRA Then AOA
    Arm/Group Description 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. 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.
    Period Title: Period 1, First 30 Days of Wear
    STARTED 83 84
    COMPLETED 83 83
    NOT COMPLETED 0 1
    Period Title: Period 1, First 30 Days of Wear
    STARTED 83 83
    COMPLETED 82 82
    NOT COMPLETED 1 1

    Baseline Characteristics

    Arm/Group Title Overall
    Arm/Group Description Lotrafilcon B and samfilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment, as randomized.
    Overall Participants 167
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    31.9
    (9.01)
    Gender (Count of Participants)
    Female
    130
    77.8%
    Male
    37
    22.2%

    Outcome Measures

    1. Primary Outcome
    Title Mean Ex-vivo Cholesterol Deposits After 30 Days of Wear
    Description 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.
    Time Frame Day 30, each product

    Outcome Measure Data

    Analysis Population Description
    Intent-to-Treat analysis set
    Arm/Group Title AIR OPTIX AQUA (AOA) ULTRA
    Arm/Group Description Lotrafilcon B contact lenses worn during Period 1 or Period 2 for 30 days Samfilcon A contact lenses worn during Period 1 or Period 2 for 30 days
    Measure Participants 167 167
    Measure Lenses 34 33
    Mean (Standard Deviation) [micrograms]
    1.63
    (2.21)
    4.89
    (3.12)

    Adverse Events

    Time Frame Adverse events (AEs) were collected from time of informed consent throughout the duration of a subject's participation in the study (at least 62 days). AEs are reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined.
    Adverse Event Reporting Description An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device.
    Arm/Group Title Pretreatment AIR OPTIX AQUA ULTRA
    Arm/Group Description All subjects who consented to participate in the study prior to the initiation of study treatment All subjects exposed to lotrafilcon B contact lenses during Period 1 or Period 2 All subjects exposed to samfilcon A contact lenses during Period 1 or Period 2
    All Cause Mortality
    Pretreatment AIR OPTIX AQUA ULTRA
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Pretreatment AIR OPTIX AQUA ULTRA
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/168 (0%) 0/166 (0%) 0/167 (0%)
    Other (Not Including Serious) Adverse Events
    Pretreatment AIR OPTIX AQUA ULTRA
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/168 (0%) 0/166 (0%) 0/167 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Sponsor reserves the right of prior review of any publication or presentation of information related to the study.

    Results Point of Contact

    Name/Title Global Medical Affairs Brand Lead, Vision Care
    Organization Alcon, A Novartis Division
    Phone 1-888-451-3937
    Email alcon.medinfo@alcon.com
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT02495948
    Other Study ID Numbers:
    • CLA560-P001
    First Posted:
    Jul 13, 2015
    Last Update Posted:
    Dec 28, 2016
    Last Verified:
    Nov 1, 2016