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OpenTrials
Completed

NCT Number: NCT02886923

Evaluation of Vision Effects of a Cosmetic Tinted Hydrogel Contact Lens

Subjects will wear 2 of 2 study contact lenses for a wearing time of approximately three to four hours at each of the visits in order to take measurements on binocular functional visual performance.

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Key information

Age range

35 year–42 year

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 between 35 and 42 years of age (inclusive).
  • The subject's vertex corrected spherical equivalent distance refraction must be in the range of -6.00 Diopters (D) to +4.00 D in each eye.
  • The subject's refractive cylinder must be ≤ 0.75 D in each eye.
  • The subject must have best corrected visual acuity of 20/30 or better in each eye.
  • The subject must be an adapted soft contact lens wearer in both eyes (defined as a minimum of 6 hours of Daily Wear (DW) for a minimum of 1 month prior to the study).
  • The subject must have normal eyes (i.e., no ocular medications or infections of any type).

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 infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV) by self-report.
  • Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
  • Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
  • Any ocular infection.
  • Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
  • Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  • Habitual contact lens type is toric, bifocal, in monovision contact lens wear, or is worn as extended wear.
  • Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
  • Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)

Treatment and study plan

Hioxifilcon A Test

Device

contact lens made with hioxifilcon A material

Hioxifilcon A With Cosmetic Ring Control

Device

contact lens made with hioxifilcon A material with a cosmetic ring on the lens

Primary outcomes

  1. The Binocular Functional Visual Performance Under Distance Day Time Conditions (250 cd/m2) for Centrally Presented High Contrasts (HC) Time Controlled Visual Acuity (TCVA) Targets.

    Time frame: 15 minutes post lens fit

    Time Controlled Visual Acuity (TCVA) was assessed at 4 m using 250 cd/m2 luminance. The luminance requirements were same at the target and at the eye.

    Binocular functional visual performance was measured for the centrally presented high contrasts targets.

Secondary outcomes

  1. The Binocular Functional Visual Performance Under Distance Night Time Conditions (2.5 cd/m2) for Centrally Presented HC TCVA Targets.

    Time frame: 15 Minutes post lens fitting

    Time Controlled Visual Acuity (TCVA) was assessed at 4 m using 2.5 cd/m2 luminance. The luminance requirements were same at the target and at the eye. Binocular functional visual performance was measured for the centrally presented high contrasts targets.

  2. The Binocular Functional Visual Performance Under Intermediate Vision Indoor Conditions (50 cd/m2) for Centrally Presented HC TCVA Targets.

    Time frame: 15 Minutes post lens fitting

    Time Controlled Visual Acuity (TCVA) was assessed at 67 cm using 50 cd/m2 luminance. The luminance requirements were same at the target and at the eye. Binocular functional visual performance was measured for the centrally presented high contrasts targets.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 1, 2016
Registry last updated
Dec 20, 2019

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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