Influence of Lens Design on Particulate Exchange in the Post-lens Tear Film

NCT03782571 | Completed Results FDA Device

• 1 other identifier: CR-6291
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 5-visit, controlled, bilateral, randomized, subject-masked, crossover (4 treatments x 4 period), non-dispensing study. Subjects will attend all study visits in their spectacle correction having not worn contact lenses on the day of the visit.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (2)

• Microsphere Clearance Rate

  The rate of microsphere clearance from the post-lens tear film was assessed by the C30 image analysis metric. Where bare eye was assigned, a droplet of microsphere suspension was applied directly onto the superior temporal conjunctiva. Where lens wear was assigned, the microsphere suspension was dispensed onto the posterior concave contact lens surface immediately prior to lens application. A series of digital images were taken over a 30-minute period (every minute for the first 10 minutes and then every 5 minutes for the next 20 minutes). Data transformed from the images were calculated by the C30 image analysis metric. Higher numbers represented greater clearance. The right eye was used to evaluate microsphere clearance.

  Post microsphere application over a 30 minute period

• Microsphere Uptake Rate

  The rate of microsphere uptake into the post-lens tear film was assessed by the U5 image analysis metric. Where bare eye was assigned, a droplet of microsphere suspension was applied directly onto the superior temporal conjunctiva. Where a lens was assigned the lens was applied and after a 10-minute settling period, a droplet of microsphere suspension was applied directly to the superior temporal conjunctiva. A series of digital images were taken over a 10-minute period (every minute for 10 minutes). Data transformed from the images were calculated by the U5 image analysis metric. Higher numbers represented greater uptake rate. The left eye was used to evaluate microsphere uptake.

  Post microsphere application over a 10 minute period

Secondary Outcomes (4)

• Lens Movement

  Post microsphere application at 30-minute timepoint (OD); post microsphere application at 10-minute timepoint (OS)

• Corneal Curvature

  Baseline

• Corneal Curvature

  Baseline

• Blink Rate

  Baseline and the 30-minute post microsphere application time point in the right eye and at the 10-minute post microsphere application timepoint in the left eye.

Study Arms (4)

Test1/Test2/Control/Test3

EXPERIMENTAL

Subjects that are adapted soft contact lens wearers between the ages of 18-40 years of age will be randomly assigned to one of four sequences. Upon completion, each subject will have worn all three lens types and been assigned the bare eye condition in both eyes.

Device: etafilcon a Test 1; Device: etafilcon A Test 2; Device: etafilcon A Test 3; Other: Control

Test2/Test3/Test1/Control

EXPERIMENTAL

Subjects that are adapted soft contact lens wearers between the ages of 18-40 years of age will be randomly assigned to one of four sequences. Upon completion, each subject will have worn all three lens types and been assigned the bare eye condition in both eyes.

Device: etafilcon a Test 1; Device: etafilcon A Test 2; Device: etafilcon A Test 3; Other: Control

Test3/Control/Test2/Test1

EXPERIMENTAL

Subjects that are adapted soft contact lens wearers between the ages of 18-40 years of age will be randomly assigned to one of four sequences. Upon completion, each subject will have worn all three lens types and been assigned the bare eye condition in both eyes.

Device: etafilcon a Test 1; Device: etafilcon A Test 2; Device: etafilcon A Test 3; Other: Control

Control/Test1/Test3/Test2

EXPERIMENTAL

Subjects that are adapted soft contact lens wearers between the ages of 18-40 years of age will be randomly assigned to one of four sequences. Upon completion, each subject will have worn all three lens types and been assigned the bare eye condition in both eyes.

Device: etafilcon a Test 1; Device: etafilcon A Test 2; Device: etafilcon A Test 3; Other: Control

Interventions

etafilcon a Test 1 DEVICE

1-DAY ACUVUE® MOIST

Control/Test1/Test3/Test2; Test1/Test2/Control/Test3; Test2/Test3/Test1/Control; Test3/Control/Test2/Test1

etafilcon A Test 2 DEVICE

1-DAY ACUVUE® MOIST for ASTIGMATISM

Control/Test1/Test3/Test2; Test1/Test2/Control/Test3; Test2/Test3/Test1/Control; Test3/Control/Test2/Test1

etafilcon A Test 3 DEVICE

1-DAY ACUVUE® MOIST MULTIFOCAL

Control/Test1/Test3/Test2; Test1/Test2/Control/Test3; Test2/Test3/Test1/Control; Test3/Control/Test2/Test1

Control OTHER

Bare Eye

Control/Test1/Test3/Test2; Test1/Test2/Control/Test3; Test2/Test3/Test1/Control; Test3/Control/Test2/Test1

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Potential subjects must satisfy all of the following criteria to be enrolled in the study:
• 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 18 and 40 (inclusive) years of age at the time of screening.
• The subject must own a wearable pair of spectacles and be willing to wear them to each study visit.
• The subject must be an adapted soft contact lens wearer in both eyes, having successfully worn contact lenses in the last six months by self-report.
• The subject must agree not to participate in other clinical research for the duration of this study.
• The subject's refractive cylinder must be \<-1.25DC in each eye.
• The subject must have best corrected visual acuity of 0.20 logMAR or better in each eye.

You may not qualify if:

• Potential subjects who meet any of the following criteria will be excluded from participating in the study:
• Currently pregnant or breast feeding (self-reported).
• Any systemic disease (e.g., Sjögren's Syndrome), infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study (at the Investigator's discretion).
• Use of topical medication such as eye drops or ointment within 24 hours prior to the study visit.
• Any history of anaphylaxis or severe allergy.
• Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.)
• Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment
• Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician)
• They have any slit lamp findings of grade 3 or higher (e.g. corneal edema, corneal neovascularization, tarsal abnormalities, conjunctival injection) or findings of \< Grade 3 which in the investigator's opinion would contraindicate contact lens wear.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (1)

The University of Manchester

Manchester, M13 9PL, United Kingdom

Location

Results Point of Contact

• Title: Thomas R. Karkkainen, OD, MS, FAAO
• Organization: Johnson & Johnson Vision Care, Inc.

TKarkkai@its.jnj.com

904 443-3402

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: December 20, 2018
• Study Start: November 16, 2018
• Primary Completion: March 25, 2019
• Study Completion: March 25, 2019
• Last Updated: May 12, 2020
• Results First Posted: May 12, 2020

Record last verified: 2020-04

Locations

GB (1)