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Evaluation of Three Daily Disposable 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: NCT02568254
Recruitment Status : Completed
First Posted : October 5, 2015
Results First Posted : July 17, 2017
Last Update Posted : July 17, 2017
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Brief Summary:
This is a single-site, 8-visit, double-masked, cross-over study involving three marketed products as study lenses. Participants will be randomly assigned each lens type, which will be worn for approximately two weeks (12 +/- 2 days) each. Participants will undergo a minimum washout period of 3 days before entering the study and undergo a minimum 7 day washout period between dispensing each lens type.

Condition or disease Intervention/treatment Phase
Visual Acuity Device: Lens 1 (etafilcon A) Device: Lens 2 (nelfilcon A) Device: Lens 3 (nesofilcon A) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Actual Study Start Date : September 3, 2015
Actual Primary Completion Date : January 18, 2016
Actual Study Completion Date : January 18, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Active Comparator: Lens 1/ Lens 2/ Lens 3
Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 1 (etafilcon A), then wear Lens 2 (nelfilcon A) second and then wear Lens 3 (nesofilcon A) third.
Device: Lens 1 (etafilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Other Name: 1-Day Acuvue® Moist®

Device: Lens 2 (nelfilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Other Name: Dailies® AquaComfort Plus®

Device: Lens 3 (nesofilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Other Name: Biotrue ONEday

Active Comparator: Lens 1 / Lens 3 / Lens 2
Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 1 (etafilcon A), then wear Lens 3 (nesofilcon A) second and then wear Lens 2 (nelfilcon A) third.
Device: Lens 1 (etafilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Other Name: 1-Day Acuvue® Moist®

Device: Lens 2 (nelfilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Other Name: Dailies® AquaComfort Plus®

Device: Lens 3 (nesofilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Other Name: Biotrue ONEday

Active Comparator: Lens 2/ Lens 3/ Lens 1
Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 2 (nelfilcon A), then wear Lens 3 (nesofilcon A) second and then wear Lens 1 (etafilcon A) third .
Device: Lens 1 (etafilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Other Name: 1-Day Acuvue® Moist®

Device: Lens 2 (nelfilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Other Name: Dailies® AquaComfort Plus®

Device: Lens 3 (nesofilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Other Name: Biotrue ONEday

Active Comparator: Lens 2 / Lens 1/ Lens 3
Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 2 (nelfilcon A), then wear Lens 1 (etafilcon A) second and then wear Lens 3 (nesofilcon A) third. Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Device: Lens 1 (etafilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Other Name: 1-Day Acuvue® Moist®

Device: Lens 2 (nelfilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Other Name: Dailies® AquaComfort Plus®

Device: Lens 3 (nesofilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Other Name: Biotrue ONEday

Active Comparator: Lens 3 / Lens 1 / Lens 2
Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 3 (nesofilcon A), then wear Lens 1 (etafilcon A) second and then wear Lens 3 (nelfilcon A) third.
Device: Lens 1 (etafilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Other Name: 1-Day Acuvue® Moist®

Device: Lens 2 (nelfilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Other Name: Dailies® AquaComfort Plus®

Device: Lens 3 (nesofilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Other Name: Biotrue ONEday

Active Comparator: Lens 3 / Lens 2 / Lens 1
Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 3 (nesofilcon A), then wear Lens 2 (nelfilcon A) second and then wear Lens 3 (etafilcon A) third.
Device: Lens 1 (etafilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Other Name: 1-Day Acuvue® Moist®

Device: Lens 2 (nelfilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Other Name: Dailies® AquaComfort Plus®

Device: Lens 3 (nesofilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Other Name: Biotrue ONEday




Primary Outcome Measures :
  1. Overall Comfort [ Time Frame: 2- Week Follow-up ]
    Clue 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.



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

Inclusion Criteria:

  • The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form;
  • The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol;
  • The subject must be willing and able to follow instructions and maintain the appointment schedule;
  • The subject must be between the age of 18 and 40 years (inclusive);
  • The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.50 Diopters (D) to -6.00 D in each eye (inclusive);
  • The subject's refractive cylinder must not exceed -1.25 Diopters of Cylinder (DC) in each eye after vertexing to the corneal plane;
  • The subject must have best corrected visual acuity of 0.2 Logarithm of the Minimum Angle of Resolution (logMAR) or better in each eye;
  • The subject must be a current wearer of spherical, soft contact lenses (no toric, bifocal or multifocal contact lenses, no extended wear or monovision) for at least 5 days/week and at least 8 hours/day during the month prior to enrollment;
  • The subject must own a wearable pair of spectacles and wear them the day of the initial visit;
  • The subject must be an existing wearer of spherical, soft contact lenses in both eyes;
  • The subject must have normal eyes (i.e., no ocular medications or infections of any type);
  • The subject must be willing to wear the study lenses for a minimum eight hours per day.

Exclusion Criteria:

  • Any ocular or systemic allergies or diseases that may interfere with contact lens wear (at the investigator's discretion);
  • Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear (at the investigator's discretion);
  • Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued);
  • Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease;
  • Any active ocular infection;
  • Is using any topical medications (excluding artificial tears (ATS)) up to two weeks prior to the screening visit;
  • Any participants whose habitual contact lenses are used as an extended wear regimen;
  • Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry;
  • Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.);
  • Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear; or clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear;
  • Any known hypersensitivity or allergic reaction to the study products;
  • Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment;
  • Employee or family member of the Centre for Contact Lens Research (e.g., Investigator, Coordinator, Technician).

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): NCT02568254


Locations
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Canada, Ontario
Centre for Contact Lens Research
Waterloo, Ontario, Canada, N2L 3G1
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
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Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT02568254    
Other Study ID Numbers: CR-5735
First Posted: October 5, 2015    Key Record Dates
Results First Posted: July 17, 2017
Last Update Posted: July 17, 2017
Last Verified: July 2017

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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