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

NCT ID: NCT03782571

Last Updated: 2020-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-16
• Study Completion Date: 2019-03-25

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Test1/Test2/Control/Test3

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.

Group Type: EXPERIMENTAL

etafilcon a Test 1

Intervention Type: DEVICE

1-DAY ACUVUE® MOIST

etafilcon A Test 2

Intervention Type: DEVICE

1-DAY ACUVUE® MOIST for ASTIGMATISM

etafilcon A Test 3

Intervention Type: DEVICE

1-DAY ACUVUE® MOIST MULTIFOCAL

Control

Intervention Type: OTHER

Bare Eye

Test2/Test3/Test1/Control

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.

Group Type: EXPERIMENTAL

etafilcon a Test 1

Intervention Type: DEVICE

1-DAY ACUVUE® MOIST

etafilcon A Test 2

Intervention Type: DEVICE

1-DAY ACUVUE® MOIST for ASTIGMATISM

etafilcon A Test 3

Intervention Type: DEVICE

1-DAY ACUVUE® MOIST MULTIFOCAL

Control

Intervention Type: OTHER

Bare Eye

Test3/Control/Test2/Test1

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.

Group Type: EXPERIMENTAL

etafilcon a Test 1

Intervention Type: DEVICE

1-DAY ACUVUE® MOIST

etafilcon A Test 2

Intervention Type: DEVICE

1-DAY ACUVUE® MOIST for ASTIGMATISM

etafilcon A Test 3

Intervention Type: DEVICE

1-DAY ACUVUE® MOIST MULTIFOCAL

Control

Intervention Type: OTHER

Bare Eye

Control/Test1/Test3/Test2

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.

Group Type: EXPERIMENTAL

etafilcon a Test 1

Intervention Type: DEVICE

1-DAY ACUVUE® MOIST

etafilcon A Test 2

Intervention Type: DEVICE

1-DAY ACUVUE® MOIST for ASTIGMATISM

etafilcon A Test 3

Intervention Type: DEVICE

1-DAY ACUVUE® MOIST MULTIFOCAL

Control

Intervention Type: OTHER

Bare Eye

Interventions

etafilcon a Test 1

1-DAY ACUVUE® MOIST

Intervention Type: DEVICE

etafilcon A Test 2

1-DAY ACUVUE® MOIST for ASTIGMATISM

Intervention Type: DEVICE

etafilcon A Test 3

1-DAY ACUVUE® MOIST MULTIFOCAL

Intervention Type: DEVICE

Control

Bare Eye

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Potential subjects must satisfy all of the following criteria to be enrolled in the study:

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 40 (inclusive) years of age at the time of screening.

4. The subject must own a wearable pair of spectacles and be willing to wear them to each study visit.

5. 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.

6. The subject must agree not to participate in other clinical research for the duration of this study.

7. The subject's refractive cylinder must be <-1.25DC in each eye.

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

Exclusion Criteria

• Potential subjects who meet any of the following criteria will be excluded from participating in the study:

1. Currently pregnant or breast feeding (self-reported).

2. 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).

3. Use of topical medication such as eye drops or ointment within 24 hours prior to the study visit.

4. Any history of anaphylaxis or severe allergy.

5. Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.)

6. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment

7. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician)

8. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The University of Manchester

Manchester, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CR-6291

Identifier Type: -

Identifier Source: org_study_id