Clinical Evaluation of An Approved Contact Lens

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02760810
• Collaborator: (none)
• Enrollment: 31
• Location: 1
• Arm: 1
• Actual Duration (Days): 14
• Patients Per Site Per Month: 67.4

Study Details

Study Description

Brief Summary

This is an 8-visit, bilateral, dispensing clinical study to evaluate the change in tear fluid pH and tear film osmolarity in an FDA-cleared contact lens in new contact lens users over a 14-day period.

Condition or Disease	Intervention/Treatment	Phase
Tear Film Characteristics	Device: Marketed Contact Lens	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Actual Study Start Date: Apr 12, 2016
• Actual Primary Completion Date: Apr 26, 2016
• Actual Study Completion Date: Apr 26, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: narafilcon A Subjects who are new contact lens wearers (neophytes) between the ages of 18-45 will be dispensed the Test Lens and evaluated over a period of 2 weeks.	Device: Marketed Contact Lens; Narafilcon A

Outcome Measures

Primary Outcome Measures

1. Tear Film Osmolarity [2-Week Follow-up]

   Tear film osmolarity was measured in each subject eye using the TearLab Osmolarity system. The instrument was placed gently into the lower lid temporal tear minuscus without simulating reflex tearing

Secondary Outcome Measures

1. Tear Film Osmolarity [1-Week Follow-up]

   Tear film osmolarity was measured in each subject eye using the TearLab Osmolarity system. The instrument was placed gently into the lower lid temporal tear minuscus without simulating reflex tearing.

2. Tear Film PH [1-Week Follow-up]

   Tear Film PH was measured using a 1mm Microglass electrode (Thermo Scientific Orion 9810BN) placed gently in lower temporal tear meniscus of non-Schirmer eye without simulating reflex tearing.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 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 18 and 45 years of age.

4. The subject must have a valid spectacle prescription with expiration date not over 1 year.

5. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.25 Diopters (D) to -6.00 D in each eye.

6. The subject's refractive cylinder must be ≤1.00 Cylindrical Diopter (DC) in each eye.

7. The subject must have best corrected visual acuity of logMAR 0.20 or better in each eye.

8. Subjects should own a wearable pair of spectacles and agree to wear them the day of the initial visit and every morning on subsequent visit days.

9. The subject must be a contact lens neophyte, defined as never having been dispensed contact lenses, or who has taken part in a non-dispensing clinical study or has been fitted with contact lenses in practice but never went on to actually wear the lenses.

10. 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 systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.

4. Use of any medication with known tear film effects within 2 weeks prior to and during the study.

5. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion..

6. Any previous, or planned, ocular or interocular surgery (e.g. radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)

7. Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g. past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.

8. Any ocular infection.

9. Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV) by self-report.

10. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.

11. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.

12. Employee of investigational clinic (e.g. Investigator, Coordinator, Technician).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aston University	Birmingham	West Midlands	United Kingdom	B4 7ET

Sponsors and Collaborators

• Johnson & Johnson Vision Care, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT02760810
• Other Study ID Numbers: CR-5815
• First Posted: May 4, 2016
• Last Update Posted: Jul 11, 2017
• Last Verified: Jun 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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

Study Results

Participant Flow

Pre-assignment Detail	A total of 31 subjects were enrolled in this study. Of the enrolled subjects 1 did not meet the eligibility criteria and 30 were dispensed the study lens. Of the dispensed subjects 29 completed the study and 1 subject was discontinued from the study.

Arm/Group Title	Narafilcon A
Arm/Group Description	All subjects wore the same lens throughout the study.
Period Title: Overall Study
STARTED	30
COMPLETED	29
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Narafilcon A
Arm/Group Description	All subjects wore the same lens throughout the study.
Overall Participants	30
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	22.8 (4.08)
Sex: Female, Male (Count of Participants)
Female	19 63.3%
Male	11 36.7%
Race/Ethnicity, Customized (Number) [Number]
Asian	18 60%
White	12 40%
Region of Enrollment (Number) [Number]
United Kingdom	30 100%

Outcome Measures

1. Primary Outcome

Title	Tear Film Osmolarity
Description	Tear film osmolarity was measured in each subject eye using the TearLab Osmolarity system. The instrument was placed gently into the lower lid temporal tear minuscus without simulating reflex tearing
Time Frame	2-Week Follow-up

Outcome Measure Data

Analysis Population Description

Subjects that completed all study visits without a major protocol deviation.

Arm/Group Title	Narafilcon A
Arm/Group Description	All subjects wore the same lens throughout the study.
Measure Participants	27
Measure Eyes	54
Mean (Standard Deviation) [mOsm/L]	293.4 (9.50)

2. Secondary Outcome

Title	Tear Film Osmolarity
Description	Tear film osmolarity was measured in each subject eye using the TearLab Osmolarity system. The instrument was placed gently into the lower lid temporal tear minuscus without simulating reflex tearing.
Time Frame	1-Week Follow-up

Outcome Measure Data

Analysis Population Description

Subjects that completed all study visits without a major protocol deviation.

Arm/Group Title	Narafilcon A
Arm/Group Description	All subjects wore the same lens throughout the study.
Measure Participants	27
Measure Eyes	54
Mean (Standard Deviation) [mOsm/L]	294.4 (9.48)

3. Secondary Outcome

Title	Tear Film PH
Description	Tear Film PH was measured using a 1mm Microglass electrode (Thermo Scientific Orion 9810BN) placed gently in lower temporal tear meniscus of non-Schirmer eye without simulating reflex tearing.
Time Frame	1-Week Follow-up

Outcome Measure Data

Analysis Population Description

Subjects that completed all study visits without a major protocol deviation.

Arm/Group Title	Narafilcon A
Arm/Group Description	All subjects wore the same lens throughout the study.
Measure Participants	27
Mean (Standard Deviation) [PH value]	6.86 (0.180)

Adverse Events

Time Frame	Throughout the duration of the study. Approximately 2-weeks per subject.
Arm/Group Title	Narafilcon A
Arm/Group Description	All subjects wore the same lens throughout the study.
All Cause Mortality
	Narafilcon A
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Narafilcon A
	Affected / at Risk (%)	# Events
Total	0/30 (0%)
Other (Not Including Serious) Adverse Events
	Narafilcon A
	Affected / at Risk (%)	# Events
Total	0/30 (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.