Evaluation of Three Daily Disposable Contact Lenses

Visual Acuity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02568254
• Other study ID #: CR-5735
• Status: Completed
• Phase: N/A
• First received: September 22, 2015
• Last updated: July 14, 2017
• Start date: September 3, 2015
• Est. completion date: January 18, 2016

Study information

• Verified date: July 2017
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: January 18, 2016
• Est. primary completion date: January 18, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Visual Acuity

Intervention

Device:
• Lens 1 (etafilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
• Lens 2 (nelfilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
• Lens 3 (nesofilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).

Locations

Country	Name	City	State
Canada	Centre for Contact Lens Research	Waterloo	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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