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

Visual Acuity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05582304
• Other study ID #: CR-6501
• Status: Completed
• Phase: N/A
• Start date: October 31, 2022
• Est. completion date: December 8, 2022

Study information

• Verified date: January 2024
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 8, 2022
• Est. primary completion date: December 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypersensitivity
• Visual Acuity

Intervention

Device:
• Test Lens
ACUVUE OASYS MAX 1-Day with TearStable Technology and OptiBlue Light Filter
• Control Lens
ACUVUE OASYS 1-Day with HydraLuxe Technology

Locations

Country	Name	City	State
United States	University of Georgia	Athens	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Area Under the Curve of Mesopic Contrast Sensitivity Under Dim Light Conditions (~3 cd/m2) With a Broadband Glare Source.	Mesopic contrast sensitivity was measured under dim light conditions (~3 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