Evaluation of Vision Effects of a Cosmetic Tinted Hydrogel Contact Lens

NCT02886923 | Completed Results FDA Device

• 1 other identifier: CR-5856
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Refractive Error

Outcome Measures

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 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.

  15 minutes post lens fit

Secondary Outcomes (2)

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

  15 Minutes post lens fitting

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

  15 Minutes post lens fitting

Study Arms (2)

Test/Control Sequence

EXPERIMENTAL

Subjects will wear the Hioxifilcon A Test contact lens and then the Hioxifilcon A with Cosmetic Ring Control contact lens for approximately three to four hours at each of the two measurement visits.

Device: Hioxifilcon A Test; Device: Hioxifilcon A With Cosmetic Ring Control

Control/Test Sequence

ACTIVE COMPARATOR

Subjects will wear the Hioxifilcon A with Cosmetic Ring Control contact lens and then the Hioxifilcon A Test contact lens for approximately three to four hours at each of the two measurement visits.

Device: Hioxifilcon A Test; Device: Hioxifilcon A With Cosmetic Ring Control

Interventions

Hioxifilcon A Test DEVICE

contact lens made with hioxifilcon A material

Control/Test Sequence; Test/Control Sequence

Hioxifilcon A With Cosmetic Ring Control DEVICE

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

Control/Test Sequence; Test/Control Sequence

Eligibility Criteria

• Age: 35 Years - 42 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (1)

Optometry Technology Group, Ltd.

London, SW1E 6AU, United Kingdom

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Ross Franklin - PRINCIPAL RESEARCH OPTOMETRIST
• Organization: Johnson & Johnson Vision

RFrankl1@its.jnj.com

904 4431768

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 1, 2016
• Study Start: August 1, 2016
• Primary Completion: January 23, 2017
• Study Completion: January 23, 2017
• Last Updated: December 20, 2019
• Results First Posted: December 20, 2019

Record last verified: 2019-12

Locations

GB (1)