Evaluation of Three Daily Disposable Contact Lenses

NCT ID: NCT02568254

Last Updated: 2017-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-03
• Study Completion Date: 2016-01-18

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Lens 1 (etafilcon A)

Intervention Type: DEVICE

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

Lens 2 (nelfilcon A)

Intervention Type: DEVICE

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

Lens 3 (nesofilcon A)

Intervention Type: DEVICE

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

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.

Group Type: ACTIVE_COMPARATOR

Lens 1 (etafilcon A)

Intervention Type: DEVICE

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

Lens 2 (nelfilcon A)

Intervention Type: DEVICE

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

Lens 3 (nesofilcon A)

Intervention Type: DEVICE

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

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 .

Group Type: ACTIVE_COMPARATOR

Lens 1 (etafilcon A)

Intervention Type: DEVICE

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

Lens 2 (nelfilcon A)

Intervention Type: DEVICE

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

Lens 3 (nesofilcon A)

Intervention Type: DEVICE

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

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).

Group Type: ACTIVE_COMPARATOR

Lens 1 (etafilcon A)

Intervention Type: DEVICE

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

Lens 2 (nelfilcon A)

Intervention Type: DEVICE

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

Lens 3 (nesofilcon A)

Intervention Type: DEVICE

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

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.

Group Type: ACTIVE_COMPARATOR

Lens 1 (etafilcon A)

Intervention Type: DEVICE

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

Lens 2 (nelfilcon A)

Intervention Type: DEVICE

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

Lens 3 (nesofilcon A)

Intervention Type: DEVICE

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

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.

Group Type: ACTIVE_COMPARATOR

Lens 1 (etafilcon A)

Intervention Type: DEVICE

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

Lens 2 (nelfilcon A)

Intervention Type: DEVICE

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

Lens 3 (nesofilcon A)

Intervention Type: DEVICE

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

Interventions

Lens 1 (etafilcon A)

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

Intervention Type: DEVICE

Lens 2 (nelfilcon A)

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

Intervention Type: DEVICE

Lens 3 (nesofilcon A)

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

Intervention Type: DEVICE

Other Intervention Names

1-Day Acuvue® Moist®; Dailies® AquaComfort Plus®; Biotrue ONEday

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre for Contact Lens Research

Waterloo, Ontario, Canada

Countries

Canada

Other Identifiers

CR-5735

Identifier Type: -

Identifier Source: org_study_id