Evaluation of Three Daily Disposable Contact Lenses

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.

Study Overview

• Status: Completed
• Conditions: Visual Acuity
• Intervention / Treatment: Device: Lens 1 (etafilcon A); Device: Lens 2 (nelfilcon A); Device: Lens 3 (nesofilcon A)

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • Centre for Contact Lens Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

6

Arms and Interventions

Participant Group / 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 Names: 1-Day Acuvue® Moist®; Device: Lens 2 (nelfilcon A); Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).; Other Names: Dailies® AquaComfort Plus®; Device: Lens 3 (nesofilcon A); Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).; Other Names: 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 Names: 1-Day Acuvue® Moist®; Device: Lens 2 (nelfilcon A); Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).; Other Names: Dailies® AquaComfort Plus®; Device: Lens 3 (nesofilcon A); Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).; Other Names: 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 Names: 1-Day Acuvue® Moist®; Device: Lens 2 (nelfilcon A); Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).; Other Names: Dailies® AquaComfort Plus®; Device: Lens 3 (nesofilcon A); Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).; Other Names: 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 Names: 1-Day Acuvue® Moist®; Device: Lens 2 (nelfilcon A); Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).; Other Names: Dailies® AquaComfort Plus®; Device: Lens 3 (nesofilcon A); Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).; Other Names: 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 Names: 1-Day Acuvue® Moist®; Device: Lens 2 (nelfilcon A); Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).; Other Names: Dailies® AquaComfort Plus®; Device: Lens 3 (nesofilcon A); Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).; Other Names: 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 Names: 1-Day Acuvue® Moist®; Device: Lens 2 (nelfilcon A); Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).; Other Names: Dailies® AquaComfort Plus®; Device: Lens 3 (nesofilcon A); Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).; Other Names: Biotrue ONEday

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Comfort	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.	2- Week Follow-up

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 3, 2015
• Primary Completion (ACTUAL): January 18, 2016
• Study Completion (ACTUAL): January 18, 2016

Study Registration Dates

• First Submitted: September 22, 2015
• First Submitted That Met QC Criteria: October 2, 2015
• First Posted (ESTIMATE): October 5, 2015

Study Record Updates

• Last Update Posted (ACTUAL): July 17, 2017
• Last Update Submitted That Met QC Criteria: July 14, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: CR-5735

Drug and device information, study documents

• 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