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Clinical and Laboratory Evaluation of 3 Contact Lenses With 4 Contact Lens Solutions

Sponsor
Johnson & Johnson Vision Care, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01791517
Collaborator
(none)
269
Enrollment
3
Locations
3
Arms
12
Actual Duration (Months)
89.7
Patients Per Site
7.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the clinical and laboratory performance of three brand name contact lenses with three recently introduced multipurpose lens care solutions (test solutions) as well as a peroxide disinfecting solution (control solution).

Condition or Disease Intervention/Treatment Phase
  • Other: Solution 1 (Test)
  • Other: Solution 2 (Test)
  • Other: Solution 3 (Test)
  • Other: Solution 4 (Control)
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
269 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Supportive Care
Official Title:
Clinical and Laboratory Evaluation of Three Contact Lens Materials With Four Contact Lens Solutions
Actual Study Start Date :
Feb 1, 2013
Actual Primary Completion Date :
Feb 1, 2014
Actual Study Completion Date :
Feb 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Other: Lens A (senofilcon A)

Subjects randomized to Lens A will be further randomized to 1 of 12 unique solution sequences; each subject will receive all four study solutions in a random order (Solution 1(Test), Solution 2(Test), Solution 3(Test), Solution 4(Control)).

Other: Solution 1 (Test)
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to all four lens care solution in a random order
Other Names:
  • Revitalens

    • Other: Solution 2 (Test)
    Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
    Other Names:
  • Pure Moist

    • Other: Solution 3 (Test)
    Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
    Other Names:
  • Biotrue

    • Other: Solution 4 (Control)
    Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
    Other Names:
  • Clear Care

    		•
    Other: Lens B (galyfilcon A)

    Subjects randomized to Lens B will be further randomized to 1 of 12 unique solution sequences; each subject will receive all four study solutions in a random order (Solution 1(Test), Solution 2(Test), Solution 3(Test), Solution 4(Control)).

    Other: Solution 1 (Test)
    Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to all four lens care solution in a random order
    Other Names:
  • Revitalens

    • Other: Solution 2 (Test)
    Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
    Other Names:
  • Pure Moist

    • Other: Solution 3 (Test)
    Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
    Other Names:
  • Biotrue

    • Other: Solution 4 (Control)
    Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
    Other Names:
  • Clear Care

    		•
    Other: Lens C (etafilcon A)

    Subjects randomized to Lens C will be further randomized to 1 of 12 unique solution sequences; each subject will l receive all four study solutions in a random order (Solution 1(Test), Solution 2(Test), Solution 3(Test), Solution 4(Control)).

    Other: Solution 1 (Test)
    Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to all four lens care solution in a random order
    Other Names:
  • Revitalens

    • Other: Solution 2 (Test)
    Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
    Other Names:
  • Pure Moist

    • Other: Solution 3 (Test)
    Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
    Other Names:
  • Biotrue

    • Other: Solution 4 (Control)
    Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
    Other Names:
  • Clear Care

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall Comfort Score (Senofilcon A Lens) [2-Week Follow-up]

      CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the senofilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).

    2. Overall Comfort Score (Galyfilcon A Lens) [2-Week Follow-up]

      CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the galyfilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).

    3. Overall Comfort Score (Etafilcon A Lens) [2-Week Follow-up]

      CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the etafilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 69 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.

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

    3. The subject must be between 18 and 69 years of age.

    4. The subject must be willing to participate in a 9-month study.

    5. The subject must require a visual correction in both eyes.

    6. Subjective refraction must result in a vertex-corrected spherical contact lens prescription of +2.00D to -8.00D in each eye.

    7. The subject must have best-corrected visual acuity of 0.20 or better in each eye.

    8. The subject must be a current wearer of spherical soft contact lenses (no bifocal contact lenses or monovision) for at least 5 days/week and at least 8 hours/day during the month prior to enrollment.

    9. The subject must require no more than -1.25D cylindrical correction in each eye after vertexing to the corneal plane.

    10. The subject must have normal eye with no evidence of abnormality or disease that in the opinion of the investigator would contraindicate contact lens wear.

    Exclusion Criteria:

    1. Self-reported current pregnancy or lactation or plans to become pregnant during the study period (subjects who report becoming pregnant during the study will be discontinued).

    2. Self-reported adverse reaction to a contact lens solution to be used in the study that in the opinion of the investigator would contraindicate use of that solution.

    3. Any previous ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.).

    4. Any clinically meaningful slit lamp findings contraindicating contact lens wear (e.g. equal to or greater than Grade 3 finding of edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection, blepharitis/meibomian gland dysfunction) on the study specific classification scale or any other ocular abnormality that in the opinion of the investigator would contraindicate contact lens wear.

    5. Any active ocular infection.

    6. Current use of topical ophthalmic medications.

    7. History of binocular vision abnormality or strabismus.

    8. More than occasional use of dry eye/rewetting drops (more than 2 times per day on average).

    9. Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV) by self-report.

    10. History of severe allergic reaction or anaphylaxis.

    11. Other active ocular disease that in the opinion of the investigator would contraindicate contact lens wear.

    12. Employee of the investigational clinic (e.g. investigator, coordinator, technician)

    13. They have taken part in any other clinical trial or research, within two weeks prior to starting this study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Houston College of Optometry Houston Texas United States 77204
    2 University of Waterloo Centre for Contact Lens Research School of Optometry Waterloo Ontario Canada
    3 University of Manchester, Department of Optometry & Neuroscience Manchester Lancashire United Kingdom

    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:
    NCT01791517
    Other Study ID Numbers:
    • CR-5230
    First Posted:
    Feb 15, 2013
    Last Update Posted:
    Jun 19, 2018
    Last Verified:
    Oct 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Pharmaceutical Solutions

    Study Results

    Participant Flow

    Recruitment Details A total of 269 Subjects were enrolled into this study. Of the enrolled 33 subjects did not meet the eligibility criteria. In Phase I 28 subjects were discontinued and 208 subjects completed Phase I. Of the 208 subjects that continued into Phase II 187 subjects completed the study and 21 subjects were discontinued from the from Phase II.
    Pre-assignment Detail Subjects were first randomized to 1 of 3 lenses(Lens A: senofilcon A, Lens B: galyfilcon A, Lens C: etafilcon A), then within each lens subjects were randomized to 1 of 12 unique solution sequences, totaling in 36 sequences. Due to such a large number of sequences for reporting purposes, subject disposition is reported by solution and period.
    Arm/Group Title Biotrue/PureMoist/Revitalens/Clear Care Biotrue/RevitaLens/Clear Care/PureMoist Biotrue/Clear Care/PureMoist/RevitaLens PureMoist/Biotrue/Clear Care/RevitaLens PureMoist/RevitaLens/Biotrue/Clear Care PureMoist/Clear Care/RevitaLens/Biotrue RevitaLens/Biotrue/PureMoist/Clear Care RevitaLens/PureMoist/Clear Care/Biotrue RevitaLens/Clear Care/Biotrue/PureMoist Clear Care/Biotrue/RevitaLens/PureMoist Clear Care/PureMoist/Biotrue/RevitaLens Clear Care/RevitaLens/PureMoist/Biotrue
    Arm/Group Description Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences. Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences. Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences. Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences. Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences. Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences. Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences. Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences. Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences. Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences. Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences. Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
    Period Title: Phase I: Period 1
    STARTED 19 20 20 19 20 20 20 20 20 20 18 20
    COMPLETED 18 18 18 17 19 19 19 20 19 19 18 19
    NOT COMPLETED 1 2 2 2 1 1 1 0 1 1 0 1
    Period Title: Phase I: Period 1
    STARTED 18 18 18 17 19 19 19 20 19 19 18 19
    COMPLETED 17 15 16 16 19 18 19 20 19 18 16 19
    NOT COMPLETED 1 3 2 1 0 1 0 0 0 1 2 0
    Period Title: Phase I: Period 1
    STARTED 17 15 16 16 19 18 19 20 19 18 16 19
    COMPLETED 17 14 16 15 18 18 19 20 19 18 16 18
    NOT COMPLETED 0 1 0 1 1 0 0 0 0 0 0 1
    Period Title: Phase I: Period 1
    STARTED 17 14 16 15 18 18 19 20 19 18 16 18
    COMPLETED 17 14 16 15 18 18 19 20 19 18 16 18
    NOT COMPLETED 0 0 0 0 0 0 0 0 0 0 0 0
    Period Title: Phase I: Period 1
    STARTED 17 14 16 15 18 18 19 20 19 18 16 18
    COMPLETED 15 14 15 15 16 14 17 17 17 15 15 17
    NOT COMPLETED 2 0 1 0 2 4 2 3 2 3 1 1

    Baseline Characteristics

    Arm/Group Title Etafilcon A Galyfilcon A Senofilcon A Total
    Arm/Group Description All subjects that were randomized to the study lens etafilcon A and 1 of 12 possible solution sequences. All subjects that were randomized to the study lens galyfilcon A and 1 of 12 possible solution sequences. All subjects that were randomized to the study lens senofilcon A and 1 of 12 possible solution sequences. Total of all reporting groups
    Overall Participants 80 78 78 236
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    30.33
    (9.726)
    30.38
    (10.091)
    29.78
    (9.938)
    30.17
    (9.879)
    Sex: Female, Male (Count of Participants)
    Female
    55
    68.8%
    50
    64.1%
    53
    67.9%
    158
    66.9%
    Male
    25
    31.3%
    28
    35.9%
    25
    32.1%
    78
    33.1%
    Race/Ethnicity, Customized (Count of Participants)
    Asian
    18
    22.5%
    18
    23.1%
    22
    28.2%
    58
    24.6%
    Black or African American
    9
    11.3%
    5
    6.4%
    6
    7.7%
    20
    8.5%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    1
    1.3%
    1
    0.4%
    White
    52
    65%
    45
    57.7%
    43
    55.1%
    140
    59.3%
    Other
    1
    1.3%
    10
    12.8%
    6
    7.7%
    17
    7.2%
    Region of Enrollment (Count of Participants)
    Canada
    28
    35%
    26
    33.3%
    26
    33.3%
    80
    33.9%
    United States
    26
    32.5%
    24
    30.8%
    27
    34.6%
    77
    32.6%
    United Kingdom
    26
    32.5%
    28
    35.9%
    25
    32.1%
    79
    33.5%

    Outcome Measures

    1. Primary Outcome
    Title Overall Comfort Score (Senofilcon A Lens)
    Description CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the senofilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).
    Time Frame 2-Week Follow-up

    Outcome Measure Data

    Analysis Population Description
    The analysis population consists of all subjects that have completed all study visits without a major protocol deviation. The number of subjects reported above is the maximum number of subjects for that solution. The number of subjects may vary per solution/lens combination, since this study was stratified by contact lens.
    Arm/Group Title Solution 1(RevitaLens) Solution 2(PureMoist) Solution 3(Biotrue) Solution 4(Clear Care)
    Arm/Group Description Subjects that received solution 1 during any of the 4 study periods. Subjects that received solution 2 during any of the 4 study periods. Subjects that received solution 3 during any of the 4 study periods. Subjects that received solution 4 during any of the 4 study periods.
    Measure Participants 69 69 69 69
    Mean (Standard Deviation) [units on a scale]
    64.42
    (22.536)
    59.73
    (25.470)
    63.75
    (21.796)
    63.47
    (23.739)
    2. Primary Outcome
    Title Overall Comfort Score (Galyfilcon A Lens)
    Description CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the galyfilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).
    Time Frame 2-Week Follow-up

    Outcome Measure Data

    Analysis Population Description
    The analysis population consists of all subjects that have completed all study visits without a major protocol deviation. The number of subjects reported above is the maximum number of subjects for that solution. The number of subjects may vary per solution/lens combination, since this study was stratified by contact lens.
    Arm/Group Title Solution 1(RevitaLens) Solution 2(PureMoist) Solution 3(Biotrue) Solution 4(Clear Care)
    Arm/Group Description Subjects that received solution 1 during any of the 4 study periods. Subjects that received solution 2 during any of the 4 study periods. Subjects that received solution 3 during any of the 4 study periods. Subjects that received solution 4 during any of the 4 study periods.
    Measure Participants 69 69 69 69
    Mean (Standard Deviation) [units on a scale]
    59.79
    (23.430)
    56.95
    (24.679)
    58.52
    (22.197)
    59.83
    (22.437)
    3. Primary Outcome
    Title Overall Comfort Score (Etafilcon A Lens)
    Description CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the etafilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).
    Time Frame 2-Week Follow-up

    Outcome Measure Data

    Analysis Population Description
    The analysis population consists of all subjects that have completed all study visits without a major protocol deviation. The number of subjects reported above is the maximum number of subjects for that solution. The number of subjects may vary per solution/lens combination, since this study was stratified by contact lens.
    Arm/Group Title Solution 1(RevitaLens) Solution 2(PureMoist) Solution 3(Biotrue) Solution 4(Clear Care)
    Arm/Group Description Subjects that received solution 1 during any of the 4 study periods. Subjects that received solution 2 during any of the 4 study periods. Subjects that received solution 3 during any of the 4 study periods. Subjects that received solution 4 during any of the 4 study periods.
    Measure Participants 65 65 65 65
    Mean (Standard Deviation) [units on a scale]
    62.57
    (25.158)
    67.44
    (19.65)
    62.43
    (21.492)
    65.33
    (21.163)

    Adverse Events

    Time Frame Throughout the duration of the study. Approximately 52 weeks.
    Adverse Event Reporting Description Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.
    Arm/Group Title Solution 1(RevitaLens): Senofilcon A Solution 1 (RevitaLens): Galyfilcon A Solution 1(RevitaLens): Etafilcon A Solution 2(PureMoist):Senofilcon A Solution 2(PureMoist): Galyfilcon A Solution 2(PureMoist): Etafilcon A Solution 3(Biotrue): Senofilcon A Solution 3(Biotrue): Galyfilcon A Solution 3(Biotrue): Etafilcon A Solution 4(Clear Care): Senofilcon A Solution 4(Clear Care): Galyfilcon A Solution 4(Clear Care): Etafilcon A
    Arm/Group Description Subjects that were randomized to the senofilcon A lens and received solution 1 during any of the 4 study periods. Subjects that were randomized to the galyfilcon A lens and received solution 1 during any of the 4 study periods. Subjects that were randomized to the etafilcon A lens and received solution 1 during any of the 4 study periods. Subjects were randomized to the senofilcon A lens and that received solution 2 during any of the 4 study periods. Subjects were randomized to the galyfilcon A lens and that received solution 2 during any of the 4 study periods. Subjects were randomized to the etafilcon A lens and that received solution 2 during any of the 4 study periods. Subjects that were randomized to the senofilcon A lens and received solution 3 during any of the 4 study periods. Subjects that were randomized to the galyfilcon A lens and received solution 3 during any of the 4 study periods. Subjects that were randomized to the etafilcon A lens and received solution 3 during any of the 4 study periods. Subjects that were randomized to the senofilcon A lens and received solution 4 during any of the 4 study periods. Subjects that were randomized to the galyfilcon A lens and received solution 4 during any of the 4 study periods. Subjects that were randomized to the etafilcon A lens and received solution 4 during any of the 4 study periods.
    All Cause Mortality
    Solution 1(RevitaLens): Senofilcon A Solution 1 (RevitaLens): Galyfilcon A Solution 1(RevitaLens): Etafilcon A Solution 2(PureMoist):Senofilcon A Solution 2(PureMoist): Galyfilcon A Solution 2(PureMoist): Etafilcon A Solution 3(Biotrue): Senofilcon A Solution 3(Biotrue): Galyfilcon A Solution 3(Biotrue): Etafilcon A Solution 4(Clear Care): Senofilcon A Solution 4(Clear Care): Galyfilcon A Solution 4(Clear Care): Etafilcon A
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Solution 1(RevitaLens): Senofilcon A Solution 1 (RevitaLens): Galyfilcon A Solution 1(RevitaLens): Etafilcon A Solution 2(PureMoist):Senofilcon A Solution 2(PureMoist): Galyfilcon A Solution 2(PureMoist): Etafilcon A Solution 3(Biotrue): Senofilcon A Solution 3(Biotrue): Galyfilcon A Solution 3(Biotrue): Etafilcon A Solution 4(Clear Care): Senofilcon A Solution 4(Clear Care): Galyfilcon A Solution 4(Clear Care): Etafilcon A
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/78 (1.3%) 0/78 (0%) 0/80 (0%) 0/78 (0%) 0/78 (0%) 0/80 (0%) 1/78 (1.3%) 0/78 (0%) 1/80 (1.3%) 1/78 (1.3%) 0/78 (0%) 0/80 (0%)
    Infections and infestations
    Retro-peritoneal abscess in the kidney area. 1/78 (1.3%) 1 0/78 (0%) 0 0/80 (0%) 0 0/78 (0%) 0 0/78 (0%) 0 0/80 (0%) 0 0/78 (0%) 0 0/78 (0%) 0 0/80 (0%) 0 0/78 (0%) 0 0/78 (0%) 0 0/80 (0%) 0
    Viral Meningitis 0/78 (0%) 0 0/78 (0%) 0 0/80 (0%) 0 0/78 (0%) 0 0/78 (0%) 0 0/80 (0%) 0 1/78 (1.3%) 1 0/78 (0%) 0 0/80 (0%) 0 0/78 (0%) 0 0/78 (0%) 0 0/80 (0%) 0
    Nervous system disorders
    Seizure 0/78 (0%) 0/78 (0%) 0/80 (0%) 0/78 (0%) 0/78 (0%) 0/80 (0%) 0/78 (0%) 0/78 (0%) 1/80 (1.3%) 2 0/78 (0%) 2 0/78 (0%) 2 0/80 (0%) 2
    Psychiatric disorders
    Mental Health / Phychiatric Hospital Admission 0/78 (0%) 0/78 (0%) 0/80 (0%) 0/78 (0%) 0/78 (0%) 0/80 (0%) 0/78 (0%) 0/78 (0%) 1/80 (1.3%) 1 0/78 (0%) 1 0/78 (0%) 1 0/80 (0%) 1
    Surgical and medical procedures
    Reconstructive Surgery on Left Upper Arm 0/78 (0%) 0 0/78 (0%) 0 0/80 (0%) 0 0/78 (0%) 0 0/78 (0%) 0 0/80 (0%) 0 0/78 (0%) 0 0/78 (0%) 0 0/80 (0%) 0 1/78 (1.3%) 1 0/78 (0%) 0 0/80 (0%) 0
    Other (Not Including Serious) Adverse Events
    Solution 1(RevitaLens): Senofilcon A Solution 1 (RevitaLens): Galyfilcon A Solution 1(RevitaLens): Etafilcon A Solution 2(PureMoist):Senofilcon A Solution 2(PureMoist): Galyfilcon A Solution 2(PureMoist): Etafilcon A Solution 3(Biotrue): Senofilcon A Solution 3(Biotrue): Galyfilcon A Solution 3(Biotrue): Etafilcon A Solution 4(Clear Care): Senofilcon A Solution 4(Clear Care): Galyfilcon A Solution 4(Clear Care): Etafilcon A
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/78 (0%) 0/78 (0%) 0/80 (0%) 0/78 (0%) 0/78 (0%) 0/80 (0%) 0/78 (0%) 0/78 (0%) 0/80 (0%) 0/78 (0%) 0/78 (0%) 0/80 (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 Chantal Coles-Brennan, PRINCIPAL RESEARCH OPTOMETRIST, Global Med Affairs
    Organization Johnson & Johnson Vision Care, Inc.
    Phone 904-443-3500 ext 3449
    Email CColesb@ITS.JNJ.com
    Responsible Party:
    Johnson & Johnson Vision Care, Inc.
    ClinicalTrials.gov Identifier:
    NCT01791517
    Other Study ID Numbers:
    • CR-5230
    First Posted:
    Feb 15, 2013
    Last Update Posted:
    Jun 19, 2018
    Last Verified:
    Oct 1, 2017