Evaluation of Electronic LogMar Visual Acuity and Contrast Sensitivity in a Population of Contact Lens Wearers

NCT ID: NCT03222037

Last Updated: 2019-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-27
• Study Completion Date: 2017-08-04

Brief Summary

This is a bilateral, non-dispensing, randomized, cross-over, single-masked study. There are a total of 3 visits where all study endpoints will be measured in all subjects at baseline with habitual lenses and under the two testing treatments sequentially in separate visits based on the randomization scheme

Conditions

Visual Acuity

Study Design

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

Study Groups

TEST/SCR

Subjects who are current soft contact lens wearers between the ages of 18 and 35 will be randomized to the two different treatments (TEST/SCR) sequentially

Group Type: EXPERIMENTAL

senofilcon A

Intervention Type: DEVICE

Acuvue Oasys 1-Day

Control

Intervention Type: DEVICE

Trial Frame with best spherocylindrical refraction (SCR)

SCR/TEST

Subjects who are current soft contact lens wearers between the ages of 18 and 35 will be randomized to the two different treatments (SCR/TEST) sequentially

Group Type: EXPERIMENTAL

senofilcon A

Intervention Type: DEVICE

Acuvue Oasys 1-Day

Control

Intervention Type: DEVICE

Trial Frame with best spherocylindrical refraction (SCR)

Interventions

senofilcon A

Acuvue Oasys 1-Day

Intervention Type: DEVICE

Control

Trial Frame with best spherocylindrical refraction (SCR)

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 35 (inclusive) years of age at the time of screening

4. The subject must be habitual contact lens wearers (defined as minimum 6 hours per day, 5 days a week over the last month)

5. The subject must meet all of the following three criteria:

1. The eyes' spherical equivalent distance refraction must be in the range of -1.00 to -9.00 D (inclusive)

2. The eyes' refractive cylinder must be less than or equal to -0.75 DC

3. Each eye must have best corrected visual acuity of 20/25 or better.

6. The subject must have normal eyes (i.e., no ocular medications or infections of any type)

Exclusion Criteria

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

1. Currently pregnant or lactating

2. Any systemic disease (e.g., Sjögren's Syndrome), allergies, 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

3. Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear or may impact the functioning of the tear film (e.g., Isotretinoin)

4. Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion

5. Any current use of ocular medication

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

7. Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the Efron scale

8. 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 would contraindicate contact lens wear

9. Any known hypersensitivity or allergic reaction to contact lens care products.

10. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment

11. Employee of clinical site (e.g., Investigator, Coordinator, Technician)

12. Current wearers of Acuvue Oasys 1-Day brand contact lenses

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 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

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CR-5968

Identifier Type: -

Identifier Source: org_study_id