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Clinical Evaluation of Opti-Free III (FID 109182) Compared to Opti-Free Plus® in Japan

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT02251561
Collaborator
(none)
36
Enrollment
2
Arms
5.9
Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to compare an investigational contact lens care product (FID 109182) to a commercially available contact lens product (Opti-Free Plus®) for corneal staining when used with Acuvue® Oasys® contact lenses. The contact lenses will be pre-soaked in the products for 24-48 hours prior to a 2-hour contralateral wear period.

Condition or Disease Intervention/Treatment Phase
  • Device: FID 109182
  • Device: Opti-Free Plus
  • Device: Senofilcon A contact lens
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, Investigator)
Official Title:
Clinical Evaluation of Opti-Free III Compared to Opti-Free Plus®
Study Start Date :
Nov 1, 2013
Actual Primary Completion Date :
May 1, 2014
Actual Study Completion Date :
May 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: FID 109182

Senofilcon A contact lens pre-soaked in FID 109182 worn in the right or left eye as randomized for 2 hours

Device: FID 109182
Investigational multipurpose contact lens cleaning and disinfecting solution
Other Names:
  • Opti-Free III

    • Device: Senofilcon A contact lens
    Commercially available silicone hydrogel contact lens
    Other Names:
  • Acuvue® Oasys®

    		•
    Active Comparator: Opti-Free Plus

    Senofilcon A contact lens pre-soaked in Opti-Free Plus worn in the fellow eye for 2 hours

    Device: Opti-Free Plus
    Commercially available multipurpose contact lens cleaning and disinfecting solution
    Other Names:
  • Opti-Free Plus®

    • Device: Senofilcon A contact lens
    Commercially available silicone hydrogel contact lens
    Other Names:
  • Acuvue® Oasys®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of Participants Scoring ≥ 2 for Corneal Staining Density With Fluorescein [Day 1, after 2 hours of wear]

      The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining density was evaluated for each eye individually against representative pictures and scored on a 0-3 scale (0=No staining; 1=Staining with low density; 2=Staining with moderate density; 3=Staining with severe density). Proportion of participants is reported as a percentage.

    Secondary Outcome Measures

    1. Proportion of Participants Scoring ≥ 2 for Corneal Staining Area With Fluorescein [Day 1, after 2 hours of wear]

      The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining area was evaluated for each eye individually against representative pictures and scored on a 0-3 scale [0=No staining; 1=Staining with small area (1 to 25% of corneal surface); 2=Staining with medium area (26 to 50% of corneal surface); 3=Staining with large area (51% of corneal surface or greater)]. Proportion of participants is reported as a percentage.

    Eligibility Criteria

    Criteria

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

    • Soft contact lenses habitual wearer, both eyes.

    • Voluntarily sign Informed Consent.

    • Other protocol-defined inclusion criteria may apply.

    Exclusion Criteria:

    • Unable to tolerate the ingredients in Opti-Free® and similar contact lens care products.

    • Potential use of eye drops during the study, including over-the-counter products, except for artificial tear eye drops.

    • Eye infection, blepharitis, iris inflammation, or severe eye inflammation.

    • Corneal staining greater than Grade 1 at baseline.

    • Pregnant, lactating, or intend to become pregnant during study period.

    • Other protocol-defined exclusion criteria may apply.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Alcon Research

    Investigators

    • Study Director: Tsunemitsu Senta, Alcon Japan, Ltd.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT02251561
    Other Study ID Numbers:
    • CVKK2013-01
    First Posted:
    Sep 29, 2014
    Last Update Posted:
    Jun 10, 2015
    Last Verified:
    Jun 1, 2015
    Keywords provided by Alcon Research
    contact lenses
    contact lens solution
    corneal staining
    fluorescein

    Study Results

    Participant Flow

    Recruitment Details Subjects were enrolled from one study site located in Japan.
    Pre-assignment Detail Of the 36 subjects enrolled in the study, 8 were exited prior to product exposure [did not meet eligibility criteria (5), and subject withdrawal (3)]. This reporting group includes all subjects who used the study products (28).
    Arm/Group Title FID 109182/Opti-Free Plus
    Arm/Group Description Senofilcon A contact lens pre-soaked in FID 109182 in 1 eye, with senofilcon A contact lens pre-soaked in Opti-Free Plus in the fellow eye. Lenses worn contralaterally for 2 hours.
    Period Title: Overall Study
    STARTED 28
    COMPLETED 28
    NOT COMPLETED 0

    Baseline Characteristics

    Arm/Group Title FID 109182/Opti-Free Plus
    Arm/Group Description Senofilcon A contact lens pre-soaked in FID 109182 in 1 eye, with senofilcon A contact lens pre-soaked in Opti-Free Plus in the fellow eye. Lenses worn contralaterally for 2 hours.
    Overall Participants 28
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    28.0
    (7.5)
    Sex: Female, Male (Count of Participants)
    Female
    14
    50%
    Male
    14
    50%
    Region of Enrollment (participants) [Number]
    Japan
    28
    100%

    Outcome Measures

    1. Primary Outcome
    Title Proportion of Participants Scoring ≥ 2 for Corneal Staining Density With Fluorescein
    Description The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining density was evaluated for each eye individually against representative pictures and scored on a 0-3 scale (0=No staining; 1=Staining with low density; 2=Staining with moderate density; 3=Staining with severe density). Proportion of participants is reported as a percentage.
    Time Frame Day 1, after 2 hours of wear

    Outcome Measure Data

    Analysis Population Description
    This analysis population includes all subjects who used the study products and had examination/observation data after use.
    Arm/Group Title FID 109182 Opti-Free Plus
    Arm/Group Description Senofilcon A contact lens pre-soaked in FID 109182 worn in 1 eye for 2 hours Senofilcon A contact lens pre-soaked in Opti-Free Plus worn in 1 eye for 2 hours
    Measure Participants 27 27
    Number [percentage of participants]
    92.6
    330.7%
    22.2
    NaN
    2. Secondary Outcome
    Title Proportion of Participants Scoring ≥ 2 for Corneal Staining Area With Fluorescein
    Description The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining area was evaluated for each eye individually against representative pictures and scored on a 0-3 scale [0=No staining; 1=Staining with small area (1 to 25% of corneal surface); 2=Staining with medium area (26 to 50% of corneal surface); 3=Staining with large area (51% of corneal surface or greater)]. Proportion of participants is reported as a percentage.
    Time Frame Day 1, after 2 hours of wear

    Outcome Measure Data

    Analysis Population Description
    This analysis population includes all subjects who used the study products and had examination/observation data after use.
    Arm/Group Title FID 109182 Opti-Free Plus
    Arm/Group Description Senofilcon A contact lens pre-soaked in FID 109182 worn in 1 eye for 2 hours Senofilcon A contact lens pre-soaked in Opti-Free Plus worn in 1 eye for 2 hours
    Measure Participants 27 27
    Number [percentage of participants]
    92.6
    330.7%
    44.4
    NaN

    Adverse Events

    Time Frame Adverse events were collected for the duration of the study.
    Adverse Event Reporting Description This analysis population includes all subjects who used the study products. In this contralateral study, number at risk is presented by eye.
    Arm/Group Title FID 109182 Opti-Free Plus
    Arm/Group Description Senofilcon A contact lens pre-soaked in FID 109182 worn in 1 eye for 2 hours Senofilcon A contact lens pre-soaked in Opti-Free Plus worn in 1 eye for 2 hours
    All Cause Mortality
    FID 109182 Opti-Free Plus
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    FID 109182 Opti-Free Plus
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/28 (0%) 0/28 (0%)
    Other (Not Including Serious) Adverse Events
    FID 109182 Opti-Free Plus
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/28 (0%) 0/28 (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 Director, Clinical & Regulatory Affairs, Division of Medical Affairs
    Organization Alcon Japan, Ltd.
    Phone
    Email alcon.medinfo@alcon.com
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT02251561
    Other Study ID Numbers:
    • CVKK2013-01
    First Posted:
    Sep 29, 2014
    Last Update Posted:
    Jun 10, 2015
    Last Verified:
    Jun 1, 2015