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Clinical Study of Approved and Investigational Contact Lenses

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ClinicalTrials.gov Identifier: NCT02708524
Recruitment Status : Completed
First Posted : March 15, 2016
Results First Posted : November 9, 2016
Last Update Posted : November 9, 2016
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Study Description
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Brief Summary:
This is a multi-site, 5-visit, double-masked, dispensing study comparing an investigational contact lens with currently-marketed contact lenses. The objective of the study is to evaluate the comfort of the lenses when worn for 30 (-2/+6) days on daily wear modality.

Condition or disease Intervention/treatment Phase
Visual Acuity Device: Senofilcon C Contact Lens Device: Comfilcon A Contact Lens Device: Lotrafilcon B Contact Lens Device: Samfilcon A Contact Lens Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 554 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : January 2016
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: Senofilcon C Wearers
Senofilcon C Wearers will wear the Senofilcon C Contact Lenses as daily wear for 30 (-2/+6) days.
 Device: Senofilcon C Contact Lens
Other Name: senofilcon C
Active Comparator: Comfilcon A Wearers
Comfilcon A Wearers will wear the Comfilcon A Contact Lens as daily wear for 30 (-2/+6) days.
 Device: Comfilcon A Contact Lens
Other Name: comfilcon A
Active Comparator: Lotrafilcon B Wearers
Lotrafilcon B Wearers will wear the Lotrafilcon B Contact Lens as daily wear for 30 (-2/+6) days.
 Device: Lotrafilcon B Contact Lens
Other Name: lotrafilcon B
Active Comparator: Samfilcon A Wearers
Samfilcon A Wearers will wear the Samfilcon A Contact Lens as daily wear for 30 (-2/+6) days.
 Device: Samfilcon A Contact Lens
Other Name: samfilcon A


Outcome Measures
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Primary Outcome Measures :
  1. Subjective Overall Comfort Composite Score [ Time Frame: Up to 1 month Follow-up ]
    Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.Range is 0 to 120. CLUE was collect at Baseline, Post Lens Fit 1-, 2-, 3- and 4- week follow-ups.

  2. Overall Comfort Individual Item [ Time Frame: 1 month follow-up ]
    Overall Comfort was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Responses are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.

  3. Comfort at the End of the Day Individual Item [ Time Frame: 1 month Follow-up ]
    Comfort at the End of the Day was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 like-rt scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.

  4. Comfort Each and Everyday Individual Item [ Time Frame: 1 month Follow-up ]
    Comfort each and everyday was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.

  5. Frequency of Lens Awareness Individual Item [ Time Frame: 1 month Follow-up ]
    Frequency of Lens Awareness was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are scaled as (Always, Frequently, Occasionally, Rarely, Never or Don't Know). Only the number of participants that reported Rarely or Never (Top-Two-Box) was reported here.

  6. Frequency of Experiencing Dryness Individual Item [ Time Frame: 1 month Follow-up ]
    Frequency of Experiencing Dryness was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are scaled as (Always, Frequently, Occasionally, Rarely, Never or Don't Know). Only the number of participants that reported Rarely or Never (Top-Two-Box) was reported here.

  7. Making Your Eyes Feel Moist Throughout the Day Individual Item [ Time Frame: Up to 1 month Follow-up ]
    Making your eyes feel moist throughout the day was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.


Secondary Outcome Measures :
  1. Subjective Overall Quality of Vision Composite Score [ Time Frame: Up to 1 month Follow-up ]
    Subjective Overall Quality of Vision was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. CLUE was collect at Baseline, Post Lens Fit 1-, 2-, 3- and 4- week follow-ups.

  2. Overall Quality of Vision Individual Item [ Time Frame: Up to 1 month Follow-up ]
    Overall Quality of Vision was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the number of participants that reported Excellent or Very good (Top-Two-Box) was reported here.

  3. Overall Opinion Individual Item [ Time Frame: Up to 1 month Follow-up ]
    Overall Opinion was assessed using a questionnaire item at Post Fit, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 instructions set forth in this clinical protocol.
  3. The subject must be between 18 to 40 years of age at the time of consent.
  4. The subject's spherical equivalent distance refraction must be in the range of -1.25 to -6.00 in each eye.
  5. The subject's refractive cylinder must be ≤1.00D in each eye.
  6. The subject must have best corrected visual acuity of 20/30 or better in each eye.
  7. The subject must be a habitual frequent replacement (reusable) daily wear spherical silicone hydrogel soft contact lens wearer in both eyes.
  8. The subject must be able to wear contact lenses for a minimum of 8 hours, 4 days per week.
  9. The subject must have normal eyes (i.e., no ocular medications or infections of any type).

Exclusion Criteria:

  1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
  2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
  3. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
  4. Any known sensitive/allergic to Ingredients of OPTI-FREE® PureMoist® solution.
  5. Any daily disposable, extended wear, monovision, toric or multi-focal contact lens correction.
  6. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion.
  7. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
  8. Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
  9. Any ocular infection.
  10. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  11. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
  12. History of binocular vision abnormality or strabismus.
  13. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV), by self-report).
  14. Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02708524


Locations
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United States, Alabama
Montgomery, Alabama, United States
United States, Florida
Fruit Cove, Florida, United States
Jacksonville, Florida, United States, 32256
Jacksonville, Florida, United States
Longwood, Florida, United States
Tallahassee, Florida, United States
Tampa, Florida, United States
United States, Georgia
Roswell, Georgia, United States
United States, Illinois
Bloomington, Illinois, United States
United States, Michigan
East Lansing, Michigan, United States
United States, Minnesota
Medina, Minnesota, United States
United States, New Jersey
Closter, New Jersey, United States
United States, New York
Vestal, New York, United States
United States, Ohio
Granville, Ohio, United States
United States, Texas
Jacksonville, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Virginia
Roanoke, Virginia, United States
United States, Wisconsin
West Allis, Wisconsin, United States
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
More Information
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Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT02708524    
Other Study ID Numbers: CR-5808
First Posted: March 15, 2016    Key Record Dates
Results First Posted: November 9, 2016
Last Update Posted: November 9, 2016
Last Verified: September 2016