Role of Glare and Spectral Filtering on Contrast Sensitivity: A Pilot Study

NCT ID: NCT05582304

Last Updated: 2024-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-31
• Study Completion Date: 2022-12-08

Brief Summary

This will be a split-plot design, randomized, parallel, double-masked feasibility study to evaluate the role of a test lens on contrast sensitivity with and without glare.

Conditions

Visual Acuity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TEST/CONTROL/Photopic CSF

Eligible subjects who are habitual wearers of silicone hydrogel contact lenses will be randomized to the photopic condition and randomized contralaterally to the TEST/CONTROL lenses.

Group Type: EXPERIMENTAL

Test Lens

Intervention Type: DEVICE

ACUVUE OASYS MAX 1-Day with TearStable Technology and OptiBlue Light Filter

Control Lens

Intervention Type: DEVICE

ACUVUE OASYS 1-Day with HydraLuxe Technology

TEST/CONTROL/Mesopic CSF

Eligible subjects who are habitual wearers of silicone hydrogel contact lenses will be randomized to the mesopic condition and randomized contralaterally to the TEST/CONTROL lenses.

Group Type: EXPERIMENTAL

Test Lens

Intervention Type: DEVICE

ACUVUE OASYS MAX 1-Day with TearStable Technology and OptiBlue Light Filter

Control Lens

Intervention Type: DEVICE

ACUVUE OASYS 1-Day with HydraLuxe Technology

CONTROL/TEST/Photopic CSF

Eligible subjects who are habitual wearers of silicone hydrogel contact lenses will be randomized to the photopic condition and randomized contralaterally to the CONTROL/TEST lenses.

Group Type: EXPERIMENTAL

Test Lens

Intervention Type: DEVICE

ACUVUE OASYS MAX 1-Day with TearStable Technology and OptiBlue Light Filter

Control Lens

Intervention Type: DEVICE

ACUVUE OASYS 1-Day with HydraLuxe Technology

CONTROL/TEST/Mesopic CSF

Eligible subjects who are habitual wearers of silicone hydrogel contact lenses will be randomized to the mesopic condition and randomized contralaterally to the CONTROL/TEST lenses.

Group Type: EXPERIMENTAL

Test Lens

Intervention Type: DEVICE

ACUVUE OASYS MAX 1-Day with TearStable Technology and OptiBlue Light Filter

Control Lens

Intervention Type: DEVICE

ACUVUE OASYS 1-Day with HydraLuxe Technology

Interventions

Test Lens

ACUVUE OASYS MAX 1-Day with TearStable Technology and OptiBlue Light Filter

Intervention Type: DEVICE

Control Lens

ACUVUE OASYS 1-Day with HydraLuxe Technology

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

The subject must:

1. 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. Be between 18 and 65 (inclusive) years of age at the time of screening.

4. By self-report, habitually wear spherical silicone hydrogel soft contact lenses in both eyes in a daily reusable or daily disposable wear modality (i.e. not extended wear modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a minimum of 5 days per week during the past 30 days.

5. Possess a wearable pair of spectacles that provide correction for distance vision.

6. The spherical equivalent of the subject's vertex corrected distance refraction must be between -1.00 D and -6.00 D (inclusive) in each eye.

7. The magnitude of the cylindrical component of the subject's vertex-corrected distance refraction must be between 0.00 D and 1.00 D (inclusive) in each eye.

8. The best corrected, monocular, distance visual acuity must be 20/25 or better in each eye.

Exclusion Criteria

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

The subject must not:

1. Be currently pregnant or lactating.

2. Be currently using any ocular medications or have any ocular infection of any type.

3. By self-report, have any ocular or systemic disease, allergies, infection, or use of medication the investigator believes might contraindicate or interfere with contact lens wear, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus [HIV]), autoimmune disease (e.g. rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. See section 9.1 for additional details regarding excluded systemic medications.

4. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.

5. Be currently wearing monovision or multifocal contact lenses.

6. Be currently wearing lenses in an extended wear modality.

7. Have participated in a contact lens or lens care product clinical trial within 30 days prior to study enrollment.

8. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site.

9. Have clinically significant (grade 3 or higher on the FDA grading scale) slit lamp findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities or bulbar injection) or other corneal or ocular disease or abnormalities that the investigator believes might contraindicate contact lens wear or may otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis).

10. Have a history of strabismus or amblyopia.

11. Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.

12. Have had any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).

13. Have signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar).

14. Have a history of eyelid injury, surgery or procedure that resulted in abnormal eyelid position or movement.

• 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

Principal Investigators

Johnson & Johnson Vision Care, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Vision Care, Inc.

Locations

University of Georgia

Athens, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CR-6501

Identifier Type: -

Identifier Source: org_study_id