Evaluation of Vision Effects of a Cosmetic Tinted Hydrogel Contact Lens

• ClinicalTrials.gov Identifier: NCT02886923
• Recruitment Status: Completed
• First Posted: September 1, 2016
• Results First Posted: December 20, 2019
• Last Update Posted: December 20, 2019
• Sponsor: Johnson & Johnson Vision Care, Inc.
• Information provided by (Responsible Party): Johnson & Johnson Vision Care, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Refractive Error	Device: Hioxifilcon A Test; Device: Hioxifilcon A With Cosmetic Ring Control	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Actual Study Start Date: August 1, 2016
• Actual Primary Completion Date: January 23, 2017
• Actual Study Completion Date: January 23, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 35 Years to 42 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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)

Contacts and Locations

Locations

United Kingdom

Optometry Technology Group, Ltd.

London, United Kingdom, SW1E 6AU

Sponsors and Collaborators

Johnson & Johnson Vision Care, Inc.

  Study Documents (Full-Text)

Documents provided by Johnson & Johnson Vision Care, Inc.:

Study Protocol and Statistical Analysis Plan  [PDF] September 22, 2016

More Information

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT02886923
• Other Study ID Numbers: CR-5856
• First Posted: September 1, 2016
• Results First Posted: December 20, 2019
• Last Update Posted: December 20, 2019
• Last Verified: December 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Refractive Errors; Eye Diseases