Evaluation of Etafilcon A Daily Disposable Lenses

Myopia Clinical Trial

Official title:

Clinical Evaluation of Two Etafilcon A Daily Disposable Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02061592
• Other study ID #: CR-5553
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: March 2014

Study information

• Verified date: August 2015
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 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 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)

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• etafilcon A

• etafilcon A

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Comfort	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.	1-week follow-up
Primary	Overall Vision	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.	1- week Follow-up
Primary	Monocular Logarithm of the Minimum Angle of Resolution (logMAR) Visual Acuity - Standard High Contrast Dim	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.	1-week follow-up
Primary	Monocular logMar Visual Acuity - Standard Low Contrast Bright	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.	1- week Follow-up