Evaluation of Three Daily Disposable Contact Lenses

NCT02568254 | Completed Results FDA Device

• 1 other identifier: CR-5735
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (6)

Lens 1/ Lens 2/ Lens 3

ACTIVE COMPARATOR

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); Device: Lens 2 (nelfilcon A); Device: Lens 3 (nesofilcon A)

Lens 1 / Lens 3 / Lens 2

ACTIVE COMPARATOR

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); Device: Lens 2 (nelfilcon A); Device: Lens 3 (nesofilcon A)

Lens 2/ Lens 3/ Lens 1

ACTIVE COMPARATOR

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); Device: Lens 2 (nelfilcon A); Device: Lens 3 (nesofilcon A)

Lens 2 / Lens 1/ Lens 3

ACTIVE COMPARATOR

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); Device: Lens 2 (nelfilcon A); Device: Lens 3 (nesofilcon A)

Lens 3 / Lens 1 / Lens 2

ACTIVE COMPARATOR

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); Device: Lens 2 (nelfilcon A); Device: Lens 3 (nesofilcon A)

Lens 3 / Lens 2 / Lens 1

ACTIVE COMPARATOR

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); Device: Lens 2 (nelfilcon A); Device: Lens 3 (nesofilcon A)

Interventions

Lens 1 (etafilcon A) DEVICE

Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).

Also known as: 1-Day Acuvue® Moist®

Lens 1 / Lens 3 / Lens 2; Lens 1/ Lens 2/ Lens 3; Lens 2 / Lens 1/ Lens 3; Lens 2/ Lens 3/ Lens 1; Lens 3 / Lens 1 / Lens 2; Lens 3 / Lens 2 / Lens 1

Lens 2 (nelfilcon A) DEVICE

Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).

Also known as: Dailies® AquaComfort Plus®

Lens 1 / Lens 3 / Lens 2; Lens 1/ Lens 2/ Lens 3; Lens 2 / Lens 1/ Lens 3; Lens 2/ Lens 3/ Lens 1; Lens 3 / Lens 1 / Lens 2; Lens 3 / Lens 2 / Lens 1

Lens 3 (nesofilcon A) DEVICE

Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).

Also known as: Biotrue ONEday

Lens 1 / Lens 3 / Lens 2; Lens 1/ Lens 2/ Lens 3; Lens 2 / Lens 1/ Lens 3; Lens 2/ Lens 3/ Lens 1; Lens 3 / Lens 1 / Lens 2; Lens 3 / Lens 2 / Lens 1

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (1)

Centre for Contact Lens Research

Waterloo, Ontario, N2L 3G1, Canada

Location

Limitations and Caveats

Caution of interpretation of results: A significant first-order carryover effect was noted in the study analysis.

Results Point of Contact

• Title: Chantal Coles-Brennan BSc, OD, FAAOPrincipal Research Optometrist
• Organization: Johnson & Johnson Vision Care Inc.

CColesb@ITS.JNJ.com

904 443 3449

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2015
• First Posted: October 5, 2015
• Study Start: September 3, 2015
• Primary Completion: January 18, 2016
• Study Completion: January 18, 2016
• Last Updated: July 17, 2017
• Results First Posted: July 17, 2017

Record last verified: 2017-07

Locations

CA (1)