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Completed

NCT Number: NCT02679976

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.

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Key information

Conditions

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Optometry Technology Group, Ltd.

London, SW1E 6AU, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

etafilcon A

Device

Marketed Multifocal Contact Lens

Primary outcomes

  1. Distance Binocular LogMAR Visual Acuity

    Time frame: 4 Hr. Post Fitting

    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 )

  2. Near Binocular LogMAR Visual Acuity

    Time frame: 4 Hr. Post Fitting

    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 )

  3. Intermediate Binocular LogMAR Visual Acuity

    Time frame: 4 Hr. Post Fitting

    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 )

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 11, 2016
Registry last updated
Sep 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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