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A Comparison of Two Daily Disposable Soft Contact Lenses

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: NCT02427477
Recruitment Status : Completed
First Posted : April 28, 2015
Results First Posted : June 13, 2016
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Brief Summary:
Approximately 120 subjects will be comparing two soft contact lenses for one week each.

Condition or disease Intervention/treatment Phase
Visual Acuity Device: senofilcon A Device: delefilcon A Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : March 2015
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: senofilcon A/ delefilcon A/ senofilcon A
Subjects were randomized to one two lens wear sequences. Subjects randomized to this sequence first wore the senofilcon A contact lens, then wore the delefilcon A contact lens second and then wore the senofilcon A contact lens third.
Device: senofilcon A
Subjects will wear the contact lenses in both eyes for seven days
Other Name: senofilcon A Prototype

Device: delefilcon A
Subjects will wear the contact lenses in both eyes for seven days
Other Name: Dailies Total 1

Active Comparator: delefilcon A/senofilcon A/ delfilcon A
Subjects were randomized to one two lens wear sequences. Subjects randomized to this sequence first wore the delefilcon A contact lens then wore the senofilcon A contact lens second and then wore the Control lens delefilcon A contact lens third.
Device: senofilcon A
Subjects will wear the contact lenses in both eyes for seven days
Other Name: senofilcon A Prototype

Device: delefilcon A
Subjects will wear the contact lenses in both eyes for seven days
Other Name: Dailies Total 1




Primary Outcome Measures :
  1. Subjective Overall Comfort [ Time Frame: 1-week 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.

  2. Subjective Overall Vision [ Time Frame: 1-week Follow-up ]
    Subjective Overall Vision was evaluated using the Contact Lens User Experience Vison 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.



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Ages Eligible for Study:   18 Years to 39 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 be appear able and willing to adhere to instruction set forth in this clinical protocol.
  3. The subject be between (and including) 18 and 39 years of age.
  4. The subject must be an adapted wearer of spherical soft contact lenses in both eyes. That is, the subject must wear their habitual lenses at least five (5) days per week and eight (8) hours per day worn for at least 30 days immediately preceding the study.
  5. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.50 to -6.00 D in each eye.
  6. The subject must have best corrected visual acuity of 20/25 or better in each eye.

Exclusion Criteria:

  1. Currently pregnant or breastfeeding (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 autoimmune disease or use of any medication, which may interfere with contact lens wear.
  4. Entropoin, Ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
  5. Any previous, or planned ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.)
  6. 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 inflammatory event (e.g. past peripheral ulcer or round scar), or any other ocular abnormality that may contraindicate contact lens wear.
  7. Any ocular infection.
  8. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  9. Monovision, multifocal, toric, or extended wear contact lens correction.
  10. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
  11. History of binocular vision abnormality or strabismus.
  12. Any infectious disease (e.g. hepatitis, tuberculosis) or contagious immunosuppressive disease (e.g. HIV) by self-report.

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): NCT02427477


Locations
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United States, Alabama
Montgomery, Alabama, United States, 36109
United States, Florida
Jacksonville Beach, Florida, United States, 32250
Longwood, Florida, United States, 32779
Winter Park, Florida, United States, 32792
United States, Ohio
Westerville, Ohio, United States, 43081
United States, Virginia
Salem, Virginia, United States, 24153
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
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Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT02427477    
Other Study ID Numbers: CR-5698
First Posted: April 28, 2015    Key Record Dates
Results First Posted: June 13, 2016
Last Update Posted: June 19, 2018
Last Verified: July 2016