The Effects of Contact Lenses With Experimental Dye on Visual Function

NCT ID: NCT03556579

Last Updated: 2019-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-15
• Study Completion Date: 2018-09-20

Brief Summary

This is a single-site, two-visit, contralateral, non-dispensing, randomized, controlled and subject-masked study to measure potential benefits of the new UV blocker.

Conditions

Ametropia

Study Design

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

Study Groups

Test/Control

For Visit 1, subjects will be randomly assigned to 1 of 2 contralateral lens sequences (Right: Test, Left: Control) OR (Right: Control, Left: Test). Then for visit 2, subjects will be randomly assigned to the same 1 of 2 contralateral lens sequences again.

Group Type: EXPERIMENTAL

senofilcon A with new UV blocker

Intervention Type: DEVICE

Test Lens

senofilcon A

Intervention Type: DEVICE

Control Lens

Control/Test

For Visit 1, subjects will be randomly assigned to 1 of 2 contralateral lens sequences (Right: Test, Left: Control) OR (Right: Control, Left: Test). Then for visit 2, subjects will be randomly assigned to the same 1 of 2 contralateral lens sequences again.

Group Type: EXPERIMENTAL

senofilcon A with new UV blocker

Intervention Type: DEVICE

Test Lens

senofilcon A

Intervention Type: DEVICE

Control Lens

Interventions

senofilcon A with new UV blocker

Test Lens

Intervention Type: DEVICE

senofilcon A

Control Lens

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

4. Be a current spherical soft silicone hydrogel contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week wear time over the last 30 days by self-report.

5. The subject's vertex-corrected spherical equivalent distance refraction must be in the range of -1.00 through -4.50 D in each eye.

6. The subject has a best corrected visual acuity of 20/25 or better in each eye.

Exclusion Criteria

1. Currently pregnant or breastfeeding.

2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.

3. Any autoimmune disease or use of medication, which may interfere with contact lens wear. Habitual medications used by successful soft contact lens wearers are considered acceptable.

4. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.

5. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).

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

7. Multifocal, toric or extended wear contact lens correction.

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

9. History of binocular vision abnormality or strabismus.

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

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

12. Any ocular infection.

13. Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Georgia Center for Sight

Statesboro, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CR-6100

Identifier Type: -

Identifier Source: org_study_id