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Contact Lenses With New UV-blocker Manufactured With Different Techniques

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03475875
Recruitment Status : Completed
First Posted : March 23, 2018
Results First Posted : June 4, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Brief Summary:
This study is a randomized, 4-visit, double-masked, 2x3 bilateral crossover, dispensing trial. The study lenses will be worn as daily wear (DW) for a period of two weeks each with one of the study lenses being worn twice. Each study lens is expected to be worn at least five (5) days per week for at least six (6) hours per day worn. There will be no washout period between study lenses.

Condition or disease Intervention/treatment Phase
Correction of Refraction Error Attenuation of Bright Light Device: senofilcon A TEST Lens Device: senofilcon A CONTROL Lens Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Contact Lenses With New UV-blocker Manufactured With Different Techniques
Actual Study Start Date : February 19, 2018
Actual Primary Completion Date : April 18, 2018
Actual Study Completion Date : April 18, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: TEST/CONTROL/CONTROL
Subjects that are of 18 years or older and current spherical soft contact lens wearers will wear the Test and Control lenses for two weeks each in random order with one of the study lenses being worn twice for a total of 6 weeks per subject.
Device: senofilcon A TEST Lens
senofilcon A with new UV blocker investigational process

Device: senofilcon A CONTROL Lens
senofilcon A with new UV blocker standard process

Experimental: CONTROL/TEST/TEST
Subjects that are of 18 years or older and current spherical soft contact lens wearers will wear the Test and Control lenses for two weeks each in random order with one of the study lenses being worn twice for a total of 6 weeks per subject.
Device: senofilcon A TEST Lens
senofilcon A with new UV blocker investigational process

Device: senofilcon A CONTROL Lens
senofilcon A with new UV blocker standard process




Primary Outcome Measures :
  1. Overall Comfort Score [ Time Frame: 2- Week Follow-up Evaluation ]
    Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. 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 with a range of 0-120. Observations from each study period are treated as independent (for the descriptive summary only). The average of all observations for each lens was reported.

  2. Overall Vision Score [ Time Frame: 2- Week Follow-up Evaluation ]
    Overall vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. 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 with a range of 0-120. Observations from each study period are treated as independent (for the descriptive summary only). The average of all observations for each lens was reported.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Potential subjects must satisfy all of the following criteria to be enrolled in the study:

    1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
    2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
    3. Healthy adult males or females age ≥18 years of age with signed informed consent.
    4. Eligible presbyopes will be those that wear full distance contact lenses in both eyes, then wear reading glasses over them.
    5. The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of DW per day, at least 5 days per week, for a minimum of 1 month prior to the study) and willing to wear the study lenses on a similar basis.
    6. Subjects must be able and willing to wear the study lenses at least 6 hours a day, a minimum of 5 days per week.
    7. The subject's vertex-corrected spherical equivalent distance refraction must be in the range of -1.00 to -6.00 (inclusive) in each eye.
    8. The subject's refractive cylinder must be ≤ -1.00 D in each eye.
    9. Have spherocylindrical best corrected visual acuity of 20/25+3 or better in each eye.

      Exclusion Criteria:

  • Potential subjects who meet any of the following criteria will be excluded from participating in the study:

    1. Currently pregnant or lactating.
    2. Any active or ongoing systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other bodily diseases or infections, by self-report, which are known to interfere with contact lens wear and/or participation in the study.
    3. Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear. Habitual medications taken by successful contact lens wearers are generally considered acceptable.
    4. Habitual toric, extended wear, or multifocal contact lens wear.
    5. Any current use of ocular medication.
    6. Any known hypersensitivity or allergic reaction to Optifree PureMoist.
    7. Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
    8. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
    9. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
    10. Any active or ongoing ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion.
    11. Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA slit-lamp scale.
    12. Binocular vision abnormality or strabismus.
    13. 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 would contraindicate contact lens wear.

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): NCT03475875


Locations
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United States, California
VRC-West
Foster City, California, United States, 94404
United States, Florida
Bartram Eye Clinic
Jacksonville, Florida, United States, 32258
United States, South Carolina
Pickens Family Eye Care
Pickens, South Carolina, United States, 29671
United States, Tennessee
Optometry Group, LLC
Memphis, Tennessee, United States, 38111
United States, Utah
William J. Bogus, OD, FAAO
Salt Lake City, Utah, United States, 84106
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
  Study Documents (Full-Text)

Documents provided by Johnson & Johnson Vision Care, Inc.:
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Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT03475875    
Other Study ID Numbers: CR-6140
First Posted: March 23, 2018    Key Record Dates
Results First Posted: June 4, 2019
Last Update Posted: June 4, 2019
Last Verified: May 2019

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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:
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Refractive Errors
Eye Diseases