Clinical and Laboratory Study of Lysozyme Deposition on Daily Disposable Contact Lenses

• ClinicalTrials.gov Identifier: NCT02365298
• Recruitment Status: Completed
• First Posted: February 18, 2015
• Results First Posted: July 13, 2017
• Last Update Posted: June 19, 2018
• Sponsor: Johnson & Johnson Vision Care, Inc.
• Information provided by (Responsible Party): Johnson & Johnson Vision Care, Inc.

Study Description

Brief Summary:

In vitro studies show that some hydrogel materials uptake more lysozyme than other hydrogel materials and that this protein remains largely active and promotes reduced cytokine response in an in vitro culture of human corneal epithelial cells. This study investigates whether these data transfer to the in vivo situation.

Condition or disease	Intervention/treatment	Phase
Visual Acuity	Device: etafilcon A; Device: nelfilcon A	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Actual Study Start Date: January 1, 2015
• Actual Primary Completion Date: June 1, 2015
• Actual Study Completion Date: June 1, 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: etafilcon A; Worn in a daily disposable modality	Device: etafilcon A; etafilcon A soft contact lens; Other Name: Marketed Investigational Soft Contact Lens; Device: nelfilcon A; nelfilcon A; Other Name: Marketed Investigational Soft Contact Lens
Active Comparator: nelfilcon A; Worn in a daily disposable modality	Device: etafilcon A; etafilcon A soft contact lens; Other Name: Marketed Investigational Soft Contact Lens; Device: nelfilcon A; nelfilcon A; Other Name: Marketed Investigational Soft Contact Lens

Outcome Measures

Primary Outcome Measures :

1. Total Protein and Total Lysosome Deposits [ Time Frame: 2 wks after baseline ]
   Measurement will be taken after the subject has worn the lenses for a full seven hours
2. Total Protein and Total Lysosome Deposits [ Time Frame: 6 wks after baseline ]
   Measurement will be taken after the subject has worn the lenses for a full seven hours
3. Total Protein and Lysosome Deposits [ Time Frame: 12 wks after baseline ]
   Measurement will be taken after the subject has worn the lenses for a full seven hours
4. Quantity of Cytokines and Albumin in Tear Fluid [ Time Frame: 2 wks after baseline ]
   Measured cytokines: IL-1β, IL-2, IL-6, IL-8, IL-10, IL-12, IL-13, and TNF-alpha Measurement will be taken after the subject has worn the lenses for a full seven hours.
5. Quantity of Cytokines and Albumin in Tear Fluid [ Time Frame: 6 wks after baseline ]
   Measured cytokines: IL-1β, IL-2, IL-6, IL-8, IL-10, IL-12, IL-13, and TNF-alpha. Measurement will be taken after the subject has worn the lenses for a full seven hours. During the 2nd period subjects continued wearing the current lens that they were randomized to for an additional 6 weeks of wear.
6. Quantity of Cytokines and Albumin in Tear Fluid [ Time Frame: 12 wks after baseline ]
   Measured cytokines: IL-1β, IL-2, IL-6, IL-8, IL-10, IL-12, IL-13, and TNF-alpha. Measurement will be taken after the subject has worn the lenses for a full seven hours. During the 2nd period subjects continued wearing the current lens that they were randomized to for an additional 6 weeks of wear.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 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 the clinical protocol.
3. The subject must be willing to follow instructions and maintain the appointment schedule.
4. The subject must be between 18 and 40 years of age (inclusive).
5. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.50D to -6.00D in each eye (inclusive).
6. The subject's refractive cylinder must not exceed -1.25DC in each eye after vertexing to the corneal plane.
7. The subject must be a current wearer of spherical, soft contact lenses (no toric, bifocal or multifocal contact lenses, no extended wear or monovision) for at least 5 days/week and at least 8 hours/day during to month prior to enrollment.
8. The subject must own a wearable pair of spectacles and wear them the day of the initial visit.
9. The subject must be an existing wearer of spherical soft contact lenses in both eyes.
10. The subject must have normal eye (i.e., no ocular medications or infections of any type).
11. The subject must be able to wear the study lenses for a minimum seven hours per day.

Exclusion Criteria:

1. Any ocular or systemic allergies or diseases that may interfere with contact lens wear (at the investigator's discretion).
2. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear (at the investigator's discretion).
3. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
4. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease.
5. Any active ocular infection.
6. Is using any topical medication including artificial tears (ATS) up to two weeks prior to the screening visit.
7. Any participants whose habitual contact lenses are used as an extended wear regimen.
8. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry.
9. 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.
10. Any know hypersensitivity or allergic reaction to study products.
11. Participation in any contact lens or lens care product clinical trial within seven days prior to study enrollment.
12. Employee or family member of the Center for Contact Lens Research (e.g., Investigator, Coordinator, Technician).

Contacts and Locations

Locations

Canada, Ontario

University of Waterloo

Waterloo, Ontario, Canada, N2L 3G1

Sponsors and Collaborators

Johnson & Johnson Vision Care, Inc.

More Information

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT02365298
• Other Study ID Numbers: CR-5695
• First Posted: February 18, 2015
• Results First Posted: July 13, 2017
• Last Update Posted: June 19, 2018
• Last Verified: April 2018

• 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