Evaluation of Vision Effects of a Cosmetic Tinted Hydrogel Contact Lens

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02886923
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.7
• Patients Per Site Per Month: 4.2

Study Details

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	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Actual Study Start Date: Aug 1, 2016
• Actual Primary Completion Date: Jan 23, 2017
• Actual Study Completion Date: Jan 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. [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. [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. [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

Criteria

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

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

	Site	City	State	Country	Postal Code
1	Optometry Technology Group, Ltd.	London		United Kingdom	SW1E 6AU

Sponsors and Collaborators

• Johnson & Johnson Vision Care, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 22, 2016

More Information

Publications

None provided.

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

• 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
• Additional relevant MeSH terms: Refractive Errors

Study Results

Participant Flow

Recruitment Details	A total of 24 subjects were enrolled into this study. Of the enrolled subjects 23 were dispensed a study lens while 1 subject failed to meet all eligibility criteria. Of the dispensed subjects, all 23 completed the study.

Arm/Group Title	Hioxilfilcon A (Test)/ Hioxifilcon A (Control)	Hioxilfilcon A (Control)/ Hioxifilcon A (Test)
Arm/Group Description	Subjects that received the Test lens during the first study period and the Control lens during the second study period.	Subjects that were received the Control lens during the first study period and the Test lens during the second stud period.
Period Title: Period 1
STARTED	12	11
COMPLETED	12	11
NOT COMPLETED	0	0
Period Title: Period 1
STARTED	12	11
COMPLETED	12	11
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Dispensed Subjects
Arm/Group Description	All subjects that were dispensed a study lens.
Overall Participants	23
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	38.0 (2.57)
Sex: Female, Male (Count of Participants)
Female	15 65.2%
Male	8 34.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	2 8.7%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	5 21.7%
White	14 60.9%
More than one race	0 0%
Unknown or Not Reported	2 8.7%
Region of Enrollment (Number) [Number]
United Kingdom	23 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All subjects who had successfully completed all required visits without any protocol deviations that the study responsible clinician documented as impacting the assessment of the hypotheses.

Arm/Group Title	Hioxifilcon A (Test)	Hioxifilcon A (Control)
Arm/Group Description	Subjects that wore the Test lens in either the first or second period of the study.	Subjects that wore the Control lens in either the first or second period of the study.
Measure Participants	23	23
Mean (Standard Deviation) [-10 x logMAR]	-0.03 (0.754)	0.33 (0.656)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All subjects who had successfully completed all required visits without any protocol deviations that the study responsible clinician documented as impacting the assessment of the hypotheses.

Arm/Group Title	Hioxifilcon A (Test)	Hioxifilcon A (Control)
Arm/Group Description	Subjects that wore the Test lens in either the first or second period of the study.	Subjects that wore the Control lens in either the first or second period of the study.
Measure Participants	23	23
Mean (Standard Deviation) [-10 x logMAR]	-2.16 (0.606)	-1.69 (0.727)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All subjects who had successfully completed all required visits without any protocol deviations that the study responsible clinician documented as impacting the assessment of the hypotheses.

Arm/Group Title	Hioxifilcon A (Test)	Hioxifilcon A (Control)
Arm/Group Description	Subjects that wore the Test lens in either the first or second period of the study.	Subjects that wore the Control lens in either the first or second period of the study.
Measure Participants	23	23
Mean (Standard Deviation) [-10 x logMAR]	-1.29 (0.673)	-1.04 (0.782)

Adverse Events

Time Frame	Throughout the entire duration of the study. Approximately 8 weeks per subject.
Arm/Group Title	Hioxifilcon A (Test)		Hioxifilcon A (Control)
Arm/Group Description	Subjects that wore the Test lens in either the first or second period of the study.		Subjects that wore the Control lens in either the first or second period of the study.
All Cause Mortality
	Hioxifilcon A (Test)		Hioxifilcon A (Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/23 (0%)
Serious Adverse Events
	Hioxifilcon A (Test)		Hioxifilcon A (Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/23 (0%)
Other (Not Including Serious) Adverse Events
	Hioxifilcon A (Test)		Hioxifilcon A (Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/23 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.