Marketed Contact Lens Real World Through Focus Curve

NCT02679976 | Completed Results

• 1 other identifier: CR-5728
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Study Lens (etafilcon A) for Multifocal

EXPERIMENTAL

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

Interventions

etafilcon A DEVICE

Marketed Multifocal Contact Lens

Study Lens (etafilcon A) for Multifocal

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (1)

Optometry Technology Group, Ltd.

London, SW1E 6AU, United Kingdom

Location

Results Point of Contact

• Title: Tom Karkkainen SR. PRINCIPAL RESEARCH OPTOMETRIST
• Organization: Johnson & Johnson Vision Care Inc.

TKarkkai@its.jnj.com

904-443-3500

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2016
• First Posted: February 11, 2016
• Study Start: July 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 15, 2016
• Results First Posted: September 15, 2016

Record last verified: 2016-07

Locations

GB (1)