Evaluation of Etafilcon A Daily Disposable Lenses

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: etafilcon A

• Registration Number: NCT02061592
• Lead Sponsor: Johnson & Johnson Vision Care, Inc.

Brief Summary

To evaluate the clinical performance of daily disposable etafilcon A lenses.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-02-07
• Study First Submitted QC: 2014-02-12
• Study First Posted: 2014-02-13
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Results First Submitted: 2015-07-06
• Results First Submitted QC: 2015-07-10
• Status Verified: 2015-08
• Results First Posted: 2015-08-07
• Last Update Submitted: 2018-06-18
• Last Update Posted: 2018-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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 at least 18 and not more than 70 years of age.
• The subject's refractive cylinder must be < 1.00 Diopters (D) in each eye.
• The subject must have best corrected visual acuity of 20/25 or better in each eye.
• The subject's required spherical contact lens prescription must be in the range of -0.50 to -7.50 D in each eye.
• The subject must be a habitual and adapted wearer of daily disposable contact lenses in both eyes.
• The subject must self-report their race as Asian
• The subject must have normal eyes (i.e., no ocular medications or infections of any type).
• The subject must demonstrate adequate mobility and 20/30 vision oculus dexter (OD) and oculus sinister (OS) with the study contact lenses.

Exclusion Criteria

• Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
• Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
• Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear.
• Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia.
• Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser in-situ keratomileusis (LASIK), etc.).
• Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
• Any ocular infection.
• Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
• Monovision or multi-focal contact lens correction.
• Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
• History of binocular vision abnormality or strabismus.
• Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self report).
• Suspicion of or recent history of alcohol or substance abuse.
• History of serious mental illness.
• History of seizures.
• Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Etafilcon A Control Lens	etafilcon A	etafilcon A
Etafilcon A Test Lens	etafilcon A	etafilcon A

Primary Outcome Measures

Name	Time	Method
Overall Comfort	1-week follow-up	Subjective assessment of comfort was performed using the Contact Lens User Experience TM (CLUE) questionnaire. CLUE was a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact lens- wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicated a more favorable/positive response with a range of 0 to 120.
Overall Vision	1- week Follow-up	Subjective assessment of vision was performed using the Contact Lens User Experience TM (CLUE) questionnaire. CLUE was a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact lens-wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicated a more favorable/positive response with a range of 0 to 120.
Monocular Logarithm of the Minimum Angle of Resolution (logMAR) Visual Acuity - Standard High Contrast Dim	1-week follow-up	LogMar visual acuity within each eye was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts. A LogMar acuity value of 0 indicates that a subject has 20/20 vision.Positive LogMar acuity values indicate worsened vision while negative LogMar acuity values would indicated improved vision.
Monocular logMar Visual Acuity - Standard Low Contrast Bright	1- week Follow-up	LogMar visual acuity within each eye was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts. A LogMar acuity value of 0 indicates that a subject has 20/20 vision. Positive LogMar acuity values indicate worsened vision while negative LogMar acuity values would indicated improved vision.