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Clinical Evaluation of DAILIES TOTAL 1® Performance in a Japanese Population

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT02710292
Collaborator
(none)
104
Enrollment
1
Location
2
Arms
4.7
Actual Duration (Months)
22.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare DAILIES TOTAL1® (DT1) to 1-DAY ACUVUE® TruEye® (TE) for Investigator-rated successful lens centration in Japanese population.

Condition or Disease Intervention/Treatment Phase
  • Device: Delefilcon A contact lenses
  • Device: Narafilcon A contact lenses
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
104 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Clinical Evaluation of DAILIES TOTAL 1® in Japanese Population - Comparison of Lens Centration Between DAILIES TOTAL 1® and 1-DAY ACUVUE® TruEye®
Actual Study Start Date :
Apr 25, 2016
Actual Primary Completion Date :
Sep 14, 2016
Actual Study Completion Date :
Sep 14, 2016

Arms and Interventions

Arm Intervention/Treatment
Other: DT1, then TE

Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for at least 7 days in a daily disposable modality.

Device: Delefilcon A contact lenses
Other Names:
  • DAILIES TOTAL 1®
  • DT1

    • Device: Narafilcon A contact lenses
    Other Names:
  • 1-DAY ACUVUE® TruEye®

    		•
    Other: TE, then DT1

    Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for at least 7 days in a daily disposable modality.

    Device: Delefilcon A contact lenses
    Other Names:
  • DAILIES TOTAL 1®
  • DT1

    • Device: Narafilcon A contact lenses
    Other Names:
  • 1-DAY ACUVUE® TruEye®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Subjects With Investigator-rated Lens Centration of "Optimal" After 10 Days of Wear [Day 10, each product]

      Lens centration was assessed by the investigator on a 5-point scale, where 0=Optimal and 4=Severe decentration (with corneal exposure). Both eyes contributed to the analysis.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Must sign an informed consent form;

    • Habitual current daily disposable soft contact lenses wearer;

    • Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Questionnaire;

    • Lenses within the power range specified in the protocol;

    • Vision correctable to 20/25 or 0.1 logMAR (logarithmic minimum angle of resolution) or better in each eye at distance with pre-study contact lenses at Visit1;

    • Acceptable lens fit with both study contact lenses;

    • Willing to wear lenses every day or at least for a minimum of 10 days, 6 hours per day, every day if possible and attend all study visits;

    • Other protocol-specified inclusion criteria may apply.

    Exclusion Criteria:

    • Currently wearing DT1 or TE sphere lenses;

    • Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;

    • Use of systemic or ocular medications in which contact lens wear could be contraindicated as determined by the investigator;

    • Eye injury or surgery within 12 weeks immediately prior to enrollment;

    • History of herpetic keratitis, ocular surgery or irregular cornea;

    • Prior refractive surgery;

    • Monocular (only 1 eye with functional vision) or fit with only 1 lens;

    • Participation in any clinical trial within 30 days of the enrollment visit;

    • Other protocol-specified exclusion criteria may apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Contact Alcon Japan, Ltd. for Trial Locations Tokyo Japan 107-0052

    Sponsors and Collaborators

    • Alcon Research

    Investigators

    • Study Director: Clinical Manager, Clinical Development, Alcon Japan, Ltd.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT02710292
    Other Study ID Numbers:
    • CLS104-P001
    First Posted:
    Mar 16, 2016
    Last Update Posted:
    Jul 2, 2018
    Last Verified:
    May 1, 2017
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Refractive Errors

    Study Results

    Participant Flow

    Recruitment Details Subjects were recruited from 6 study sites located in Japan.
    Pre-assignment Detail Of the 104 subjects, 5 were exited as screen failures prior to being enrolled. This reporting group includes all enrolled subjects (99).
    Arm/Group Title DT1, Then TE TE, Then DT1
    Arm/Group Description Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for at least 7 days in a daily disposable modality. Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for at least 7 days in a daily disposable modality.
    Period Title: Period 1, First 10 Days of Wear
    STARTED 47 52
    COMPLETED 46 49
    NOT COMPLETED 1 3
    Period Title: Period 1, First 10 Days of Wear
    STARTED 46 49
    COMPLETED 46 49
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title Overall
    Arm/Group Description Delefilcon A and narafilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment.
    Overall Participants 99
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    39.9
    (9.7)
    Sex: Female, Male (Count of Participants)
    Female
    72
    72.7%
    Male
    27
    27.3%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Subjects With Investigator-rated Lens Centration of "Optimal" After 10 Days of Wear
    Description Lens centration was assessed by the investigator on a 5-point scale, where 0=Optimal and 4=Severe decentration (with corneal exposure). Both eyes contributed to the analysis.
    Time Frame Day 10, each product

    Outcome Measure Data

    Analysis Population Description
    This analysis population includes all subjects who used the study device and in whom data after the use of the study device were available (Full Analysis Set).
    Arm/Group Title Dailies Total1 TruEye
    Arm/Group Description Delefilcon A contact lenses worn bilaterally during Period 1 or Period 2 for for at least 7 days in a daily disposable modality. Narafilcon A contact lenses worn bilaterally during Period 1 or Period 2 for at least 7 days in a daily disposable modality.
    Measure Participants 95 97
    Number [percentage of subjects]
    89.5
    47.4

    Adverse Events

    Time Frame Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 26 days). AEs are reported as pretreatment and treatment-emergent.
    Adverse Event Reporting Description AEs were 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 investigational medical device (test article). AE's were obtained as volunteered and elicited comments from the subjects and as observations by the Investigator.
    Arm/Group Title Pretreatment Dailies Total1 TruEye
    Arm/Group Description All subjects who consented to participate in the study prior to initiation of study treatment All subjects exposed to delefilcon A contact lenses All subjects exposed to narafilcon A contact lenses
    All Cause Mortality
    Pretreatment Dailies Total1 TruEye
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Pretreatment Dailies Total1 TruEye
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/104 (0%) 0/96 (0%) 0/98 (0%)
    Other (Not Including Serious) Adverse Events
    Pretreatment Dailies Total1 TruEye
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/104 (0%) 7/96 (7.3%) 23/98 (23.5%)
    Eye disorders
    Dry Eye 0/104 (0%) 5/96 (5.2%) 5/98 (5.1%)
    Punctate keratitis 0/104 (0%) 2/96 (2.1%) 19/98 (19.4%)

    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 Clinical Manager
    Organization Alcon Japan Ltd.
    Phone 1-888-451-3937
    Email alcon.medinfo@alcon.com
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT02710292
    Other Study ID Numbers:
    • CLS104-P001
    First Posted:
    Mar 16, 2016
    Last Update Posted:
    Jul 2, 2018
    Last Verified:
    May 1, 2017