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Multi-Center Clinical Evaluation of Two Daily Disposable Contact Lenses (Study 2)

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT01917162
Collaborator
(none)
86
Enrollment
1
Location
2
Arms
2
Duration (Months)
42.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the subjective performance of two daily disposable contact lenses with respect to comfort and handling.

Condition or Disease Intervention/Treatment Phase
  • Device: Nelfilcon A contact lens
  • Device: UltraFilcon B contact lens
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
86 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Multi-Center Clinical Evaluation of Two Daily Disposable Contact Lenses
Study Start Date :
Sep 1, 2013
Actual Primary Completion Date :
Nov 1, 2013
Actual Study Completion Date :
Nov 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Other: Nelfilcon A/UltraFilcon B

Nelfilcon A contact lenses, followed by UltraFilcon B contact lenses. Each product worn bilaterally for one week in a daily wear, daily disposable modality.

Device: Nelfilcon A contact lens
Soft contact lens CE-marked for daily disposable wear.
Other Names:
  • DAILIES® AquaComfort Plus®

    • Device: UltraFilcon B contact lens
    Silicone hydrogel soft contact lens CE-marked for daily disposable wear. Private-label versions may be used.
    Other Names:
  • Procornea BYO Air Daily

    		•
    Other: UltraFilcon B/Nelfilcon A

    UltraFilcon B contact lenses, followed by Nelfilcon A contact lenses. Each product worn bilaterally for one week in a daily wear, daily disposable modality.

    Device: Nelfilcon A contact lens
    Soft contact lens CE-marked for daily disposable wear.
    Other Names:
  • DAILIES® AquaComfort Plus®

    • Device: UltraFilcon B contact lens
    Silicone hydrogel soft contact lens CE-marked for daily disposable wear. Private-label versions may be used.
    Other Names:
  • Procornea BYO Air Daily

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Initial comfort [Baseline]

      Initial Comfort (within 10-15 minutes of lens insertion) will be assessed bilaterally by the participant at time of dispense. Initial Comfort will be graded on a 1-10 scale (10=cannot be felt, 1=painful).

    Secondary Outcome Measures

    1. End of Day Comfort [Day 7]

      End of Day Comfort will be assessed by the participant as a retrospective, bilateral evaluation of 1 week of wear. End of Day Comfort will be graded on a 1-10 scale (10=cannot be felt, 1=painful).

    2. Overall Comfort [Day 7]

      Overall Comfort will be assessed by the participant as a retrospective, bilateral evaluation of 1 week of wear. Overall Comfort will be graded on a 1-10 scale (10=cannot be felt, 1=painful).

    3. Overall Handling at Time of Removal [Day 7]

      Overall Handling at Time of Removal will be assessed by the participant as a retrospective, bilateral evaluation of 1 week of wear. Overall Handling at Time of Removal will be graded on a 1-10 scale (10=excellent, very easy; 1=unmanageable).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Adapted soft contact lens wearer;

    • Spherical distance contact lens prescription between -1.00 and -6.00 diopter (inclusive);

    • Spectacle cylinder ≤0.75 diopter in the least astigmatic eye, ≤1.00 diopter in the other;

    • Correctable to 6/9 (20/30) in both eyes;

    • Read, understand, and sign the informed consent;

    • Willing to comply with the wear schedule;

    • Willing to comply with the study visit schedule;

    • Other protocol-defined inclusion criteria may apply.

    Exclusion Criteria:

    • Any active corneal infection, injury or inflammation;

    • Systemic or ocular allergies which might interfere with contact lens wear;

    • Systemic or ocular disease which might interfere with contact lens wear;

    • Strabismus or amblyopia;

    • Corneal refractive surgery and any anterior segment surgery;

    • Use of systemic/topical medication contraindicating contact lens wear;

    • Use of gas permeable contact lenses within 1 month preceding the study;

    • Participation in any concurrent clinical trial or in the last 30 days;

    • Other protocol-defined exclusion criteria may apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Visioncare Research Ltd Farnham Surrey United Kingdom GU9 7EN

    Sponsors and Collaborators

    • Alcon Research

    Investigators

    • Study Director: Joachim Nick, Dipl. Ing., Alcon Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT01917162
    Other Study ID Numbers:
    • C-13-033
    First Posted:
    Aug 6, 2013
    Last Update Posted:
    Nov 7, 2013
    Last Verified:
    Nov 1, 2013
    Keywords provided by Alcon Research
    contact lenses
    daily disposable contact lenses
    silicone hydrogel
    contact lens comfort
    near-sighted
    Additional relevant MeSH terms:
    Refractive Errors

    Study Results

    No Results Posted as of Nov 7, 2013