Marketed Contact Lens Real World Through Focus Curve

This is a single-visit prospective study to establish a real world Marketed Contact Lens 'Through Focus Curve' (TFC) measurement by comparing the consistency of vision between myopes and hyperopes. 33 subjects will be enrolled (at least 15 myopes and 15 hyperopes), who are 40 years of age or older, for a 1-visit, 4-hour study for measurements to be taken.

Study Overview

• Status: Completed
• Conditions: Visual Acuity
• Intervention / Treatment: Device: etafilcon A

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW1E 6AU
    • Optometry Technology Group, Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 ≥40 years of age.
• The subjects' optimal vertexed spherical equivalent distance correction must be between -6.00 Diopters (D) and +4.00 D in each eye.
• The subject's refractive cylinder must be ≤ -0.75 D in each eye.
• The subject's ADD power must be in the range of +0.75 to +2.50 D in each eye.
• The subject must have best corrected visual acuity of 20/25 or better for each eye.
• The subject can be either a new contact lens wearer or an existing soft contact lens wearer.

Exclusion Criteria:

• Currently pregnant or lactating.
• Any ocular or systemic allergies that contraindicate contact lens wear.
• Any ocular or systemic disease, autoimmune disease, or use of medication that contraindicates contact lens wear.
• Any ocular abnormality that may interfere with contact lens wear.
• Use of any ocular medication, with the exception of rewetting drops.
• Any previous intraocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
• Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, and conjunctival injection) which may contraindicate contact lens wear.
• History of herpetic keratitis.
• Any ocular infection or inflammation.
• Any corneal distortion or irregular cornea.
• History of binocular vision abnormality or strabismus.
• Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV).
• History of diabetes.
• Participant in unrelated research involving test product within 30 days before planned study visit.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Study Lens (etafilcon A) for Multifocal; All Subjects in this study will wear the same contact lenses. However subjects wil be stratified as Hyperopes or Myopes using a 1:1 allocation. The study lens will be worn for a period of approximately 4 hours to allow lenses to settle on the eyes.	Device: etafilcon A; Marketed Multifocal Contact Lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance Binocular LogMAR Visual Acuity	Distance Binocular LogMAR Visual Acuity was measured at 4m for Low luminance ( 2.5 CD/M^2 ), Medium luminance ( 50 CD/M^2 ) and High luminance ( 250 CD/M^2 )	4 Hr. Post Fitting
Near Binocular LogMAR Visual Acuity	Near Binocular LogMAR Visual Acuity was measured at 40cm for Low luminance ( 2.5 CD/M^2 ), Medium luminance ( 50 CD/M^2 ) and High luminance ( 250 CD/M^2 )	4 Hr. Post Fitting
Intermediate Binocular LogMAR Visual Acuity	intermediate Binocular LogMAR Visual Acuity was measured at 67cm for Low luminance ( 2.5 CD/M^2 ), Medium luminance ( 50 CD/M^2 ) and High luminance ( 250 CD/M^2 )	4 Hr. Post Fitting

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (ACTUAL): August 1, 2015
• Study Completion (ACTUAL): August 1, 2015

Study Registration Dates

• First Submitted: January 22, 2016
• First Submitted That Met QC Criteria: February 8, 2016
• First Posted (ESTIMATE): February 11, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): September 15, 2016
• Last Update Submitted That Met QC Criteria: July 27, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: CR-5728