Evaluation of Three Daily Disposable Contact Lenses

Not Applicable

Completed

Conditions: Visual Acuity

Interventions: Device: Lens 1 (etafilcon A)
Device: Lens 2 (nelfilcon A)
Device: Lens 3 (nesofilcon A)

Registration Number: NCT02568254

Lead Sponsor: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 78

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 & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lens 1 / Lens 3 / Lens 2	Lens 3 (nesofilcon A)	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.
Lens 2 / Lens 1/ Lens 3	Lens 2 (nelfilcon A)	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).
Lens 3 / Lens 2 / Lens 1	Lens 3 (nesofilcon A)	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.
Lens 1 / Lens 3 / Lens 2	Lens 1 (etafilcon A)	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.
Lens 2/ Lens 3/ Lens 1	Lens 1 (etafilcon A)	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 .
Lens 1/ Lens 2/ Lens 3	Lens 1 (etafilcon A)	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.
Lens 1/ Lens 2/ Lens 3	Lens 2 (nelfilcon A)	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.
Lens 2 / Lens 1/ Lens 3	Lens 3 (nesofilcon A)	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).
Lens 1/ Lens 2/ Lens 3	Lens 3 (nesofilcon A)	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.
Lens 1 / Lens 3 / Lens 2	Lens 2 (nelfilcon A)	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.
Lens 2/ Lens 3/ Lens 1	Lens 2 (nelfilcon A)	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 .
Lens 2 / Lens 1/ Lens 3	Lens 1 (etafilcon A)	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).
Lens 3 / Lens 1 / Lens 2	Lens 2 (nelfilcon A)	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.
Lens 3 / Lens 2 / Lens 1	Lens 1 (etafilcon A)	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.
Lens 3 / Lens 2 / Lens 1	Lens 2 (nelfilcon A)	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.
Lens 2/ Lens 3/ Lens 1	Lens 3 (nesofilcon A)	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 .
Lens 3 / Lens 1 / Lens 2	Lens 1 (etafilcon A)	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.
Lens 3 / Lens 1 / Lens 2	Lens 3 (nesofilcon A)	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.

Primary Outcome Measures

Name	Time	Method
Overall Comfort	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.

Secondary Outcome Measures