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Clinical Assessment of DAILIES TOTAL1® (DT1) Multifocal

Sponsor
Alcon, a Novartis Company (Industry)
Overall Status
Completed
CT.gov ID
NCT02871375
Collaborator
(none)
170
Enrollment
2
Arms
2.5
Actual Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate DAILIES TOTAL1® Multifocal (DTl MF) contact lenses in current multifocal contact lens wearers with symptoms of end of day discomfort compared to their habitual multifocal contact lens correction.

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

Study Design

Study Type:
Interventional
Actual Enrollment :
170 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
DAILIES TOTAL1® Multifocal Clinical Assessment in Challenging Patients
Actual Study Start Date :
Aug 30, 2016
Actual Primary Completion Date :
Nov 14, 2016
Actual Study Completion Date :
Nov 14, 2016

Arms and Interventions

Arm Intervention/Treatment
Other: DT1 MF, then Habitual

Delefilcon A multifocal contact lenses in Period 1, followed by subject's habitual multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 14 ± 3 days.

Device: Delefilcon A multifocal contact lenses
Multifocal contact lenses worn in a daily wear, daily disposable modality (new pair of lenses each morning)
Other Names:
  • DAILIES TOTAL1® multifocal

    • Device: Habitual multifocal contact lenses
    Multifocal contact lenses worn per subject's habitual prescription and habitual daily wear modality
    Other: Habitual, then DT1 MF

    Subject's habitual multifocal contact lenses in Period 1, followed by delefilcon A multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 14 ± 3 days.

    Device: Delefilcon A multifocal contact lenses
    Multifocal contact lenses worn in a daily wear, daily disposable modality (new pair of lenses each morning)
    Other Names:
  • DAILIES TOTAL1® multifocal

    • Device: Habitual multifocal contact lenses
    Multifocal contact lenses worn per subject's habitual prescription and habitual daily wear modality

    Outcome Measures

    Primary Outcome Measures

    1. Binocular High Contrast/High Illumination (HC/HI) Visual Acuity (VA) at Intermediate Distance (80 cm) [Day 14, each product]

      Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HC/HI VA was assessed binocularly (both eyes together) at 80 centimeters using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and measured in logarithm of the minimum angle of resolution (logMAR). A lower logMAR value indicates better visual acuity.

    Secondary Outcome Measures

    1. Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score [Day 14, each product]

      The abbreviated CLDEQ-8 is an 8-item questionnaire used to assess comfort and dryness. Total CLDEQ-8 score ranged from 0 to 37, where a lower score represented less symptomology.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Must sign an informed consent document;

    • Current daily wearer of soft multifocal contact lenses for at least 6 months with symptoms of contact lens discomfort as defined by the prescreening Eligibility Questionnaire;

    • Requires a near spectacle add of +0.50 to +2.50 diopters (D) (inclusive);

    • Requires lenses within the power range of study lenses to be fitted;

    • Best corrected VA (BCVA) of 20/30 (0.2 logarithmic minimum angle of resolution [logMAR]) or better in each eye at distance;

    • Willing to wear study lenses for a minimum of 5 days per week, 6 hours per day, and attend all study visits;

    • Other protocol-defined inclusion criteria may apply.

    Exclusion Criteria:

    • Any eye condition that contraindicates wearing contact lenses as determined by the Investigator;

    • Any use of medications for which contact lens wear could be contraindicated, as determined by the Investigator;

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

    • Fitted with monovision;

    • Prior refractive surgery (e.g., laser vision correction, photorefractive keratectomy, etc.);

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

    • Currently wearing DT1 MF contact lenses;

    • Other protocol-defined exclusion criteria may apply.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Alcon, a Novartis Company

    Investigators

    • Study Director: Clinical Project Manager, PLS, Alcon, A Novartis Division

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alcon, a Novartis Company
    ClinicalTrials.gov Identifier:
    NCT02871375
    Other Study ID Numbers:
    • CLE914-P001
    First Posted:
    Aug 18, 2016
    Last Update Posted:
    Jul 2, 2018
    Last Verified:
    Oct 1, 2017
    Keywords provided by Alcon, a Novartis Company
    myopia
    presbyopia
    Additional relevant MeSH terms:
    Refractive Errors

    Study Results

    Participant Flow

    Recruitment Details Subjects were recruited from 11 study centers located in the United States.
    Pre-assignment Detail Of the 170 enrolled, 2 subjects were exited as screen failures prior to randomization. An additional 2 subjects were randomized in error but not exposed. This reporting group includes all randomized and exposed subjects (166).
    Arm/Group Title DT1 MF / Habitual MF Habitual MF / DT1 MF
    Arm/Group Description Delefilcon A multifocal (MF) contact lenses in Period 1, followed by subject's habitual multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 14 ± 3 days. Subject's habitual multifocal contact lenses in Period 1, followed by delefilcon A multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 14 ± 3 days.
    Period Title: Period 1, First 14 Days of Wear
    STARTED 89 77
    COMPLETED 89 76
    NOT COMPLETED 0 1
    Period Title: Period 1, First 14 Days of Wear
    STARTED 89 76
    COMPLETED 89 76
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title Overall
    Arm/Group Description Delefilcon A multifocal contact lenses and subject's habitual multifocal contact lenses worn bilaterally during Period 1 and Period 2 in a crossover assignment.
    Overall Participants 166
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    52.0
    (5.14)
    Sex: Female, Male (Count of Participants)
    Female
    128
    77.1%
    Male
    38
    22.9%

    Outcome Measures

    1. Primary Outcome
    Title Binocular High Contrast/High Illumination (HC/HI) Visual Acuity (VA) at Intermediate Distance (80 cm)
    Description Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HC/HI VA was assessed binocularly (both eyes together) at 80 centimeters using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and measured in logarithm of the minimum angle of resolution (logMAR). A lower logMAR value indicates better visual acuity.
    Time Frame Day 14, each product

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set. Number Analyzed is the number of subjects with non-missing responses.
    Arm/Group Title DT1 MF Habitual MF
    Arm/Group Description Delefilcon A multifocal contact lenses worn bilaterally for 14 ± 3 days in Period 1 and Period 2 Subject's habitual multifocal contact lenses worn bilaterally for 14 ± 3 days in Period 1 and Period 2.
    Measure Participants 152 153
    Mean (Standard Deviation) [logMAR]
    -0.07
    (0.10)
    -0.09
    (0.10)
    2. Secondary Outcome
    Title Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score
    Description The abbreviated CLDEQ-8 is an 8-item questionnaire used to assess comfort and dryness. Total CLDEQ-8 score ranged from 0 to 37, where a lower score represented less symptomology.
    Time Frame Day 14, each product

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set. Number Analyzed is the number of subjects with non-missing responses.
    Arm/Group Title DT1 MF Habitual MF
    Arm/Group Description Delefilcon A multifocal contact lenses worn bilaterally for 14 ± 3 days in Period 1 and Period 2 Subject's habitual multifocal contact lenses worn bilaterally for 14 ± 3 days in Period 1 and Period 2
    Measure Participants 165 165
    Period One
    9.9
    (5.4)
    17.0
    (7.1)
    Period Two
    11.6
    (6.3)
    13.0
    (6.2)
    Overall
    10.7
    (5.9)
    14.9
    (6.9)

    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 44 days). AEs are reported as pre-treatment and treatment-emergent.
    Adverse Event Reporting Description An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the investigational medical device (test article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
    Arm/Group Title Pre-treatment DT1 MF Habitual MF
    Arm/Group Description All subjects who consented to participate in the study prior to exposure to study lenses dispensed for 14-day wear Delefilcon A multifocal contact lenses worn bilaterally for 14 ± 3 days in Period 1 and Period 2 Subject's habitual multifocal contact lenses worn bilaterally for 14 ± 3 days in Period 1 and Period 2.
    All Cause Mortality
    Pre-treatment DT1 MF Habitual MF
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/170 (0%) 0/165 (0%) 0/166 (0%)
    Serious Adverse Events
    Pre-treatment DT1 MF Habitual MF
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/170 (0%) 0/165 (0%) 0/166 (0%)
    Other (Not Including Serious) Adverse Events
    Pre-treatment DT1 MF Habitual MF
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/170 (0%) 0/165 (0%) 0/166 (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 Franchise Head, Vision Care
    Organization Alcon, A Novartis Division
    Phone 1-888-451-3937
    Email alcon.medinfo@alcon.com
    Responsible Party:
    Alcon, a Novartis Company
    ClinicalTrials.gov Identifier:
    NCT02871375
    Other Study ID Numbers:
    • CLE914-P001
    First Posted:
    Aug 18, 2016
    Last Update Posted:
    Jul 2, 2018
    Last Verified:
    Oct 1, 2017