Clinical Evaluation of Spherical Soft Contact Lenses, Toric Soft Contact Lenses and Spectacles in Low Astigmats

Visual Acuity Clinical Trial

Official title:

Clinical Evaluation of Spherical Soft Contact Lenses, Toric Soft Contact Lenses and Spectacles in Low Astigmats

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05056870
• Other study ID #: CR-6459
• Status: Completed
• Phase: N/A
• Start date: September 15, 2021
• Est. completion date: March 3, 2022

Study information

• Verified date: April 2023
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This will be a 5-visit, randomized, partially single-masked, bilateral wear, dispensing, 2-treatment × 2-period crossover study with spectacle-wear washout and wash-in periods.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: March 3, 2022
• Est. primary completion date: March 3, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

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

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

4. By self-report, habitually wear soft contact lenses (sphere or toric) 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 2 days per week during the past 4 weeks.

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

6. In both eyes, have magnitude of the cylinder component of their vertex-corrected distance refraction greater than or equal to 0.625 DC and less than 1.625 DC.

7. In both eyes, have the mean sphere of their vertex-corrected distance refraction minus half of the indicated contact lens label cylinder power be between -0.875 to -4.625 DS (inclusive).

8. For each eye, have the cylinder axis of their distance refraction between 165° and 15° (i.e., 180±15°, inclusive) or between 75° and 105° (i.e., 90±15°, inclusive).

9. For both eyes, have the sphere power of their habitual spectacles within ±0.50 Diopters Sphere (DS) (inclusive) of the sphere power of their current subjective refraction.

10. For both eyes, have the cylinder power of their habitual spectacles within ±0.50 Diopters Cylinder (DC) (inclusive) of the cylinder power of their current subjective refraction.

11. For both eyes, have the cylinder axis of their habitual spectacles within ±20° (inclusive) of the cylinder axis of their current subjective refraction.

12. Achieve monocular VA of 20/30 or better with their habitual spectacles in both eyes.

Exclusion Criteria:

• Potential subjects who meet any of the following criteria will be excluded from

participating in the study:

1. Be currently pregnant or lactating.

2. Be diabetic.

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

4. By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that 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.

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

6. Be currently wearing monovision or multifocal contact lenses.

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

8. Have a history of strabismus or amblyopia.

9. 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.

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

11. 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 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).

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

13. Have had or have planned (within the study period) any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).

Related Conditions & MeSH terms

• Visual Acuity

Intervention

Device:
• ACUVUE Oasys 1-Day with HydraLuxe Technology for Astigmatism
TEST
• ACUVUE Oasys 1-Day with HydraLuxe Technology
CONTROL

Locations

Country	Name	City	State
United States	Indiana University School of Optometry	Bloomington	Indiana
United States	University Hospitals of Cleveland Medical Center	Cleveland	Ohio
United States	ProCare Vision Center	Granville	Ohio
United States	Windward Vision Ctr Associates Inc.	Kaneohe	Hawaii
United States	Sabal Eye Care	Longwood	Florida
United States	Maitland Vision Center	Maitland	Florida
United States	Total Eye Care	Memphis	Tennessee
United States	Advanced Eye Care	Raytown	Missouri
United States	Eyecenter Optometric	Rocklin	California
United States	Botetourt Eyecare, LLC	Salem	West Virginia
United States	Tyler Texas Associates	Tyler	Texas
United States	Sacco Eye Group	Vestal	New York
United States	Professional Visioncare Inc.	Westerville	Ohio

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	High Luminance High Contrast Monocular Visual Acuity (LogMAR)	Visual Acuity was collected for each subject eye at distance (4 meter) using a Logarithm of Minimal Angle of Resolution (logMAR) visual acuity scale. This was evaluated under high luminance and high contrast conditions (HLHC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 1-week follow-up visit. A value of 0.0 logMAR is equivalent to 20/20 Snellen Visual Acuity. Lower values of visual acuity indicate better vision. The average logMAR Visual Acuity was reported for each lens type.	1-Week Follow-up
Secondary	CLUE Vision Score	CLUE Vision Score was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The average CLUE vision score for each lens type was reported.	1-Week Follow-up
Secondary	High Luminance High Contrast Monocular Visual Acuity (LogMAR)	Visual Acuity was collected for each subject eye at distance (4 meter) using a Logarithm of Minimal Angle of Resolution (logMAR) visual acuity scale. This was evaluated under high luminance and high contrast conditions (HLHC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 1-week follow-up visit. A value of 0.0 logMAR is equivalent to 20/20 Snellen Visual Acuity. Lower values of visual acuity indicate better vision. The average logMAR Visual Acuity was reported for each lens type. Data summaries for the Control lens are reported for the first primary measure outcome.	1-Week Follow-up
Secondary	Subjective Contact Lens Preference		1-Week Follow-up