Evaluation of Three Daily Disposable Contact Lenses

Johnson & Johnson Vision Care, Inc.1 site in 1 country78 target enrollmentSeptember 3, 2015

ConditionsVisual Acuity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.
Enrollment: 78
Locations: 1
Primary Endpoint: Overall Comfort
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 3, 2015

End Date

January 18, 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Johnson & Johnson Vision Care, Inc.

Responsible Party

Sponsor

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;

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;

Outcomes

Primary Outcomes

Overall Comfort

Time Frame: 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.