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Evaluation of Vision Effects of a Cosmetic Tinted Hydrogel Contact Lens

Primary Purpose

Refractive Error

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Hioxifilcon A Test
Hioxifilcon A With Cosmetic Ring Control
Sponsored by
Johnson & Johnson Vision Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractive Error

Eligibility Criteria

35 Years - 42 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Optometry Technology Group, Ltd.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test/Control Sequence

Control/Test Sequence

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 29, 2016
Last Updated
December 18, 2019
Sponsor
Johnson & Johnson Vision Care, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02886923
Brief Title
Evaluation of Vision Effects of a Cosmetic Tinted Hydrogel Contact Lens
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
January 23, 2017 (Actual)
Study Completion Date
January 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Vision Care, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Error

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test/Control Sequence
Arm Type
Experimental
Arm Description
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.
Arm Title
Control/Test Sequence
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Hioxifilcon A Test
Intervention Description
contact lens made with hioxifilcon A material
Intervention Type
Device
Intervention Name(s)
Hioxifilcon A With Cosmetic Ring Control
Intervention Description
contact lens made with hioxifilcon A material with a cosmetic ring on the lens
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
15 minutes post lens fit
Secondary Outcome Measure Information:
Title
The Binocular Functional Visual Performance Under Distance Night Time Conditions (2.5 cd/m2) for Centrally Presented HC TCVA Targets.
Description
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.
Time Frame
15 Minutes post lens fitting
Title
The Binocular Functional Visual Performance Under Intermediate Vision Indoor Conditions (50 cd/m2) for Centrally Presented HC TCVA Targets.
Description
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.
Time Frame
15 Minutes post lens fitting

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Optometry Technology Group, Ltd.
City
London
ZIP/Postal Code
SW1E 6AU
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Vision Effects of a Cosmetic Tinted Hydrogel Contact Lens

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