Clinical Characterization of Symptomatic Populations

NCT ID: NCT03319212

Last Updated: 2019-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-29
• Study Completion Date: 2018-08-15

Brief Summary

This is an unmasked, non-randomized, single arm, stratified, dispensing investigation of symptomatic and asymptomatic subject populations. Subjects will be assigned to a single study lens type to be worn bilaterally for approximately 4 weeks followed by no contact lens wear for 1 week.

Conditions

Ametropia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active Comparator

Subjects that are between the ages 18-55 and are current spherical soft contact lens wearers will be assigned to a single study lens type to be worn bilaterally for approximately 4 weeks followed by no contact lens wear for 1 week.

Group Type: OTHER

senofilcon A contact lenses

Intervention Type: DEVICE

Senofilcon A Daily Disposable Contact Lenses

Interventions

senofilcon A contact lenses

Senofilcon A Daily Disposable Contact Lenses

Intervention Type: DEVICE

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. Appear able and willing to adhere to the instructions set forth in this clinical protocol.

3. Between 18 and 55 (inclusive) years of age at the time of screening.

4. Be a current soft contact lens wearer in both eyes with a minimum of 3 days/week wear time over the last 1 month by self-report.

5. Have a baseline CLDEQ-8 score of either:

1. 7 or lower

2. 15 or greater

6. Subjects must possess a functional / usable pair of spectacles and bring them to the visit (only if applicable - to the investigators discretion).

7. Subjects must pass a pre-screening questionnaire.

8. Subjects must be willing to discontinue all contact lens wear for approximately 1 week/

9. Subjects must present to visit 1 with their habitual lenses on eye for at least 6 hours.

Exclusion Criteria

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

1. Currently pregnant or lactating, by self-report.

2. Any ocular or systemic allergies, disease or use of medication which may interfere with contact lens wear (at the discretion of the investigator).

3. Any active ocular abnormalities/conditions that may interfere with contact lens wear (at the discretion of the investigator).

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

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

6. Habitual contact lens wear modality as extended wear (≥1 night per month of extended wear).

7. Habitual contact lens is rigid gas permeable, toric, monovision or multi-focal

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

9. Participation in any contact lens or lens care product clinical trial within 2 weeks prior to study enrollment.

10. Employee or employee's immediate family member of clinical site (e.g., Investigator, Coordinator, Technician).

11. Current habitual use of Restasis, Xiidra, ocular steroids, or any medication (RX or OTC) that may interfere with contact lens wear (at the discretion of the investigator).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

VRC-East

Jacksonville, Florida, United States

University of Waterloo Center for Contact Lens Research

Waterloo, Ontario, Canada

Countries

United States; Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CR-5969

Identifier Type: -

Identifier Source: org_study_id