Marketed Contact Lens Real World Through Focus Curve

NCT ID: NCT02679976

Last Updated: 2016-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2015-08-31

Brief Summary

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.

Conditions

Visual Acuity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

etafilcon A

Intervention Type: DEVICE

Marketed Multifocal Contact Lens

Interventions

etafilcon A

Marketed Multifocal Contact Lens

Intervention Type: DEVICE

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 ≥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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Optometry Technology Group, Ltd.

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

CR-5728

Identifier Type: -

Identifier Source: org_study_id