Late Night Study 2: End-of-Day Assessment of Asymptomatic and Symptomatic Soft Lens Wearers

NCT ID: NCT03871543

Last Updated: 2023-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 196 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2022-02-03

Brief Summary

This is a 2-Part, 8-Visit, single-center, open-label, bilateral and dispensing clinical study. In Part 1 (Visits 1-4) all subjects will be Test Lens 1, in Part 2 (Visits 1-4) eligible subjects will be dispensed Test Lens 2 based on their responses to the CLDEQ-8 questionnaire. Subjects scoring between 11 and 19 on the CLDEQ will not continue into Part 2

Conditions

Visual Acuity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1

All eligible subjects enrolled into Part 1 will be fit and dispensed with Test Lens 1

Group Type: OTHER

AquaComfort Plus

Intervention Type: DEVICE

Test Lens 1

Part 2

All eligible subjects (based on CLDEQ responses) enrolled into Part 2 will be fit and dispensed with Test Lens 2 and will follow the same procedures as Part 1.

Group Type: OTHER

Acuvue Oasys 1-Day

Intervention Type: DEVICE

Test Lens 2

Interventions

AquaComfort Plus

Test Lens 1

Intervention Type: DEVICE

Acuvue Oasys 1-Day

Test Lens 2

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Potential subjects must satisfy all of the criteria listed to be enrolled in the study.

1. They are 18-45 years of age (inclusive).

2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.

3. They are willing and able to follow the protocol.

4. They agree not to participate in other clinical research while enrolled on this study.

5. They currently use daily disposable soft daily wear contact lenses (worn bilaterally) (within the last six months) which may be spherical, toric or multifocal.

6. They agree to wear their lenses for at least 12-14 hours per day.

7. They own a wearable pair of spectacles (by self-report).

8. They have a spherical contact lens prescription in the range +6.00 to -10.00 DS (based on the calculated ocular refraction).

9. They have up to a maximum of 1.00 DC of refractive astigmatism (based on the calculated ocular refraction).

10. They have best corrected distance visual acuity of at least 0.20 binocularly

Exclusion Criteria

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

1. They have an ocular disorder which would normally contraindicate contact lens wear.

2. They have a systemic disorder which would normally contraindicate contact lens wear.

3. No ocular topical medications (including comfort drops) from 24 hours prior to study visits or during the wear of any study lenses.

4. They are regularly using anti-inflammatory or pain medications (i.e. medication routinely used more than twice per week).

5. They have had cataract surgery.

6. They have had corneal refractive surgery.

7. They are pregnant or breast-feeding.

8. They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV) or a history of anaphylaxis or severe allergic reactions.

9. They are an employee or immediate family member of an employee of the clinical site (e.g. Investigator, Coordinator, Technician).

10. They have taken part in any other clinical trial or research within two weeks prior to starting this study.

11. History of allergy to sodium fluorescein or lissamine green.

12. They have any corneal distortion e.g. as a result of previous rigid lens wear or have keratoconus.

13. They any slit lamp findings of Efron Grade 3 or greater (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: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Vision Care, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Vision Care, Inc.

Locations

The University of Manchester - Eurolens Research

Manchester, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CR-6290

Identifier Type: -

Identifier Source: org_study_id