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.

Study Overview

• Status: Completed
• Conditions: Refractive Error
• Intervention / Treatment: Device: Hioxifilcon A Test; Device: Hioxifilcon A With Cosmetic Ring Control

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW1E 6AU
    • Optometry Technology Group, Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 31 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. The subject must be between 35 and 42 years of age (inclusive).
4. 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.
5. The subject's refractive cylinder must be ≤ 0.75 D in each eye.
6. The subject must have best corrected visual acuity of 20/30 or better in each eye.
7. 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).
8. The subject must have normal eyes (i.e., no ocular medications or infections of any type).

Exclusion Criteria:

1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
3. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV) by self-report.
4. 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.
5. Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
6. Any ocular infection.
7. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
8. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
9. Habitual contact lens type is toric, bifocal, in monovision contact lens wear, or is worn as extended wear.
10. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
11. Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test/Control Sequence; 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; contact lens made with hioxifilcon A material; Device: Hioxifilcon A With Cosmetic Ring Control; contact lens made with hioxifilcon A material with a cosmetic ring on the lens
Active Comparator: Control/Test Sequence; 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; contact lens made with hioxifilcon A material; Device: Hioxifilcon A With Cosmetic Ring Control; contact lens made with hioxifilcon A material with a cosmetic ring on the lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Binocular Functional Visual Performance Under Distance Night Time Conditions (2.5 cd/m2) for Centrally Presented HC TCVA Targets.	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.	15 Minutes post lens fitting
The Binocular Functional Visual Performance Under Intermediate Vision Indoor Conditions (50 cd/m2) for Centrally Presented HC TCVA Targets.	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.	15 Minutes post lens fitting

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): January 23, 2017
• Study Completion (Actual): January 23, 2017

Study Registration Dates

• First Submitted: August 29, 2016
• First Submitted That Met QC Criteria: August 29, 2016
• First Posted (Estimate): September 1, 2016

Study Record Updates

• Last Update Posted (Actual): December 20, 2019
• Last Update Submitted That Met QC Criteria: December 18, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CR-5856

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes