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

NCT05582304 | Completed Results FDA Device

• 1 other identifier: CR-6501
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve of Photopic Contrast Sensitivity Function Under Bright Light Conditions (∼120 cd/m2) With a Broadband Glare Source

  Photopic contrast sensitivity was measured under bright light conditions (\~120 cd/m2) with a broadband glare source at five spatial frequencies (1.6, 3.2, 8, 16 and 24 cpd) using the University of Georgia system. The area under the log contrast sensitivity function (AULCSF) was derived by first calculating the logarithm of contrast sensitivity as logCS = log10(contrast sensitivity), and then AULCSF was calculated using logCS and the log (base 10) of each spatial frequency based on the trapezoidal rule per eye per subject. The AULCSF was computed by trapezoidal integration of the logarithm of the contrast sensitivity (vertical axis) as a function of the logarithm of spatial frequency (horizontal axis). The unit of the horizontal axis is log(cpd) since spatial frequency is in the unit of cycles per degree (cpd). Although, sensitivity is a unitless parameter, to aid interpretation, the units of AULCSF are described as log(sensitivity)\*log(cpd).

  Up to 2 hours post-fitting

Secondary Outcomes (1)

• Area Under the Curve of Mesopic Contrast Sensitivity Under Dim Light Conditions (∼3 cd/m2) With a Broadband Glare Source.

  Up to 2 hours post-fitting

Study Arms (4)

TEST/CONTROL/Photopic CSF

EXPERIMENTAL

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.

Device: Test Lens; Device: Control Lens

TEST/CONTROL/Mesopic CSF

EXPERIMENTAL

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.

Device: Test Lens; Device: Control Lens

CONTROL/TEST/Photopic CSF

EXPERIMENTAL

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.

Device: Test Lens; Device: Control Lens

CONTROL/TEST/Mesopic CSF

EXPERIMENTAL

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.

Device: Test Lens; Device: Control Lens

Interventions

Test Lens DEVICE

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

CONTROL/TEST/Mesopic CSF; CONTROL/TEST/Photopic CSF; TEST/CONTROL/Mesopic CSF; TEST/CONTROL/Photopic CSF

Control Lens DEVICE

ACUVUE OASYS 1-Day with HydraLuxe Technology

CONTROL/TEST/Mesopic CSF; CONTROL/TEST/Photopic CSF; TEST/CONTROL/Mesopic CSF; TEST/CONTROL/Photopic CSF

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Potential subjects must satisfy all of the following criteria to be enrolled in the study:
• The subject must:
• Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
• Appear able and willing to adhere to the instructions set forth in this clinical protocol.
• Be between 18 and 65 (inclusive) years of age at the time of screening.
• 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.
• Possess a wearable pair of spectacles that provide correction for distance vision.
• 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.
• 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.
• The best corrected, monocular, distance visual acuity must be 20/25 or better in each eye.

You may not qualify if:

• Potential subjects who meet any of the following criteria will be excluded from participating in the study:
• The subject must not:
• Be currently pregnant or lactating.
• Be currently using any ocular medications or have any ocular infection of any type.
• 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.
• Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
• Be currently wearing monovision or multifocal contact lenses.
• Be currently wearing lenses in an extended wear modality.
• Have participated in a contact lens or lens care product clinical trial within 30 days prior to study enrollment.
• 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.
• 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).
• Have a history of strabismus or amblyopia.
• Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.
• Have had any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).
• Have signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar).

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (1)

University of Georgia

Athens, Georgia, 30602, United States

Location

Results Point of Contact

• Title: John R Buch
• Organization: Johnson & Johnson Vision Care, Inc. (JJVC)

jbuch@its.jnj.com

1-800-843-2020

Study Officials

• Johnson & Johnson Vision Care, Inc. Clinical Trial

  Johnson & Johnson Vision Care, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 17, 2022
• Study Start: October 31, 2022
• Primary Completion: December 8, 2022
• Study Completion: December 8, 2022
• Last Updated: January 31, 2024
• Results First Posted: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)