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Clinical Evaluation of Two Daily Disposable Contact Lenses

Sponsor
Johnson & Johnson Vision Care, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01875471
Collaborator
(none)
279
Enrollment
11
Locations
2
Arms
2
Duration (Months)
25.4
Patients Per Site
12.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study is to compare the ease of removing two daily disposable soft contact lenses off the eye.

Condition or Disease Intervention/Treatment Phase
  • Device: delefilcon A
  • Device: narafilcon A
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
279 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
Clinical Evaluation of Two Daily Disposable Contact Lenses
Study Start Date :
Jun 1, 2013
Actual Primary Completion Date :
Aug 1, 2013
Actual Study Completion Date :
Aug 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: delefilcon A

Spherical daily disposable soft contact lens

Device: delefilcon A
Daily disposable soft contact lens to be worn at least 8 hours daily
Other Names:
  • DAILIES Total 1

    		•
    Experimental: narafilcon A

    Spherical daily disposable soft contact lens Class 1 UV blocking

    Device: narafilcon A
    Daily disposable contact lens to be worn at least 8 hours daily
    Other Names:
  • 1-Day ACUVUE TruEye

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Subjective Ease of Lens Removal [Day 7]

      After 1-week of lens wear, each subject was asked to rate a question, 'Ease of taking the lenses off of your eyes', using 5-point scale (1=Excellent, 2=Very Good, 3=Good, 4=Fair, 5=Poor).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. The subject must be between 18 and 45 years of age (inclusive)with no presbyopic add.

    2. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. This should be recorded on the Case Report Form (CRF).

    3. The subject must be willing to wear the study lenses for at least 8 hours per day, at least 6 days between visits.

    4. The subject must be a current successful spherical soft contact lens wearer in both eyes.

    5. The subject must appear willing and able to adhere to the instructions set forth in this clinical protocol.

    6. The subject's subjective refraction must result in a vertex corrected spherical contact lens prescription in the range of -1.00D to -6.00D (inclusive) in each eye.

    7. The subject's refractive astigmatism must be less than or equal to -0.75D in both eyes.

    8. The subject must have corrective visual acuity of 6/9 (20/30) or better in each eye.

    9. The subject must require a visual correction in both eyes (no monofit or monovision allowed).

    Exclusion Criteria:

    1. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.

    2. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.

    3. Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or infiltrates or any other abnormalities of the cornea which would contraindicate contact lens wear.

    4. Clinically significant (Grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.

    5. Any ocular infection.

    6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.

    7. Currently pregnant or lactating (subject who become pregnant during the study will be discontinued).

    8. Diabetes.

    9. Infectious diseases (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. HIV).

    10. Amblyopia

    11. Evidence of lid abnormality or infection (including blepharitis/meibomitis)

    12. Conjunctival abnormality or infection.

    13. Any active ocular disease.

    14. Employee or family member of the staff of the investigational site.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Knowle Bristol United Kingdom BS4 2AL
    2 Portchester Hampshire United Kingdom PO16 9UN
    3 Hay-on-Wye Herefordshire United Kingdom HR3 5EQ
    4 St. Albans Herts United Kingdom AL1 3LH
    5 Eastcote, Pinner Middlesex United Kingdom HA5 1RJ
    6 Cardiff South Glamorgan United Kingdom CF24 3RQ
    7 Farnham Surrey United Kingdom GU9 7EN
    8 Brighton United Kingdom BN1 1RH
    9 London United Kingdom N2 8AG
    10 London United Kingdom NW4 3FB
    11 Norwich United Kingdom NR2 1PB

    Sponsors and Collaborators

    • Johnson & Johnson Vision Care, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Johnson & Johnson Vision Care, Inc.
    ClinicalTrials.gov Identifier:
    NCT01875471
    Other Study ID Numbers:
    • CR-5305
    First Posted:
    Jun 11, 2013
    Last Update Posted:
    Jun 19, 2018
    Last Verified:
    May 1, 2016
    Additional relevant MeSH terms:
    Refractive Errors

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail A total of 279 subjects were enrolled in the study; 4 did not meet the eligibility criteria, 2 prematurely discontinued and 273 completed the study. Of those 273 completers, 23 were excluded from the primary analysis due to major protocol deviations; hence, 250 completed the study per protocol and were included in the analysis.
    Arm/Group Title Delefilcon A Narafilcon A
    Arm/Group Description Spherical daily disposable soft contact lens Spherical daily disposable soft contact lens with UV blocking
    Period Title: Overall Study
    STARTED 137 138
    Completed Per Protocol 127 123
    COMPLETED 136 137
    NOT COMPLETED 1 1

    Baseline Characteristics

    Arm/Group Title Delefilcon A Narafilcon A Total
    Arm/Group Description Spherical daily disposable soft contact lens delefilcon A: Daily disposable soft contact lens to be worn at least 8 hours daily Spherical daily disposable soft contact lens Class 1 UV blocking narafilcon A: Daily disposable contact lens to be worn at least 8 hours daily Total of all reporting groups
    Overall Participants 137 138 275
    Age (Count of Participants)
    <=18 years
    11
    8%
    9
    6.5%
    20
    7.3%
    Between 18 and 65 years
    126
    92%
    129
    93.5%
    255
    92.7%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    30.0
    (8.17)
    29.0
    (7.69)
    29.5
    (7.93)
    Sex: Female, Male (Count of Participants)
    Female
    99
    72.3%
    76
    55.1%
    175
    63.6%
    Male
    38
    27.7%
    62
    44.9%
    100
    36.4%
    Region of Enrollment (participants) [Number]
    United Kingdom
    88
    64.2%
    87
    63%
    175
    63.6%
    United States
    49
    35.8%
    51
    37%
    100
    36.4%

    Outcome Measures

    1. Primary Outcome
    Title Subjective Ease of Lens Removal
    Description After 1-week of lens wear, each subject was asked to rate a question, 'Ease of taking the lenses off of your eyes', using 5-point scale (1=Excellent, 2=Very Good, 3=Good, 4=Fair, 5=Poor).
    Time Frame Day 7

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Delefilcon A Narafilcon A
    Arm/Group Description Spherical daily disposable soft contact lens Spherical daily disposable soft contact lens with UV blocking
    Measure Participants 127 123
    Excellent
    45
    32.8%
    76
    55.1%
    Very Good
    23
    16.8%
    34
    24.6%
    Good
    24
    17.5%
    10
    7.2%
    Fair
    23
    16.8%
    3
    2.2%
    Poor
    12
    8.8%
    0
    0%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Delefilcon A Narafilcon A
    Arm/Group Description Spherical daily disposable soft contact lens delefilcon A: Daily disposable soft contact lens to be worn at least 8 hours daily Spherical daily disposable soft contact lens Class 1 UV blocking narafilcon A: Daily disposable contact lens to be worn at least 8 hours daily
    All Cause Mortality
    Delefilcon A Narafilcon A
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Delefilcon A Narafilcon A
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/137 (0%) 0/138 (0%)
    Other (Not Including Serious) Adverse Events
    Delefilcon A Narafilcon A
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/137 (0%) 0/138 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Daria Wicks
    Organization Johnson & Johnson Vision Care
    Phone 1 904 443-1391
    Email RA-VISUS-ClnclStds@its.jnj.com
    Responsible Party:
    Johnson & Johnson Vision Care, Inc.
    ClinicalTrials.gov Identifier:
    NCT01875471
    Other Study ID Numbers:
    • CR-5305
    First Posted:
    Jun 11, 2013
    Last Update Posted:
    Jun 19, 2018
    Last Verified:
    May 1, 2016