Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05778786
Other study ID # CR-6521
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 13, 2023
Est. completion date May 24, 2023

Study information

Verified date July 2023
Source Johnson & Johnson Vision Care, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This will be a 4-visit, randomized, controlled, single-masked, bilateral wear, dispensing, 2-treatment, 2-sequence, 2-period crossover study.


Recruitment information / eligibility

Status Completed
Enrollment 188
Est. completion date May 24, 2023
Est. primary completion date May 24, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 39 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 39 years of age (inclusive) at the time of screening. 4. Habitually wear soft contact lenses in both eyes in a daily or daily disposable wear modality (i.e., not extended wear modality). Habitual wearer is defined as a minimum of 6 hours per day, for a minimum of 2 days per week during the past four weeks. 5. Possess a wearable pair of spectacles that provide correction for distance vision. 6. In both eyes, have refractive error suitable for correction with the toric contact lens powers available in this study: 1. Sphere powers (DS) -1.50 through -4.00 in 0.25 steps 2. Cylinder powers (DC) -0.75 and -1.25 3. Axes (°) 170, 180, 10, 80, 90, 100 7. Have best corrected monocular distance visual acuity of 20/30 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 diabetic. 3. Be currently using any ocular medications or have an 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.).

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Acuvue Oasys 1 Day for Astigmatism
CONTROL
TRA100/TRA200 series toric contact lens with HEVL-blocking chromophore
TEST

Locations

Country Name City State
United States ProCare Vision Centers Granville Ohio
United States Stam & Associates Eye Care Jacksonville Florida
United States Omega Vision Center Longwood Florida
United States Maitland Vision Center - North Orlando Ave Maitland Florida
United States Complete Eye Care of Medina Medina Minnesota
United States Optometry Group, LLC Memphis Tennessee
United States Botetourt Eyecare, LLC Salem Virginia
United States Tyler Eye Associates Tyler Texas
United States Sacco Eye Group Vestal New York
United States Professional Vision Care Inc. - Westerville 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 Slit Lamp Findings (SLF) SLFs (Grade 3 or higher) related to study lens wear will be assessed for each eye at all study visits. SLFs will be evaluated and graded using the FDA Grading scale from 0 to 4, where Grade 0 represents the absence of findings and 1 to 4 representing successively worse findings. At the 1 week follow up
Primary Acceptable Lens Fit Acceptable lens fit will be assessed at all study visits (scheduled and unscheduled) for each subject eye. Lens fit will be deemed unacceptable if any one of the following criteria are met:
limbal exposure at primary gaze or with extreme eye movement;
edge lift;
excessive movement in primary up gaze;
insufficient movement in all three of the following conditions: primary gaze, up gaze, and push up test.
At the 1 week follow up
Primary Visual Acuity (logMAR) Visual acuity (VA) will be measured monocularly at the 1-week follow-up evaluation under high-contrast (HLHC) (>400 lux, 120 - 200 cd/m2) conditions at a test distance of 4 meters. At the 1 week follow up
Primary Toric Lens Orientation Absolute lens orientation Toric lens orientation (scribe mark position relative to 6 o'clock) will be assessed for each eye at least 15 minutes after lens insertion. 15 minutes after lens insertion
Primary Rotation Stability with blinks Rotational stability with blinks will be assessed for each eye at least 15 minutes after lens insertion. 15 minutes after lens insertion
Primary Subjective Vision Subjective vision will be assessed using the Contact Lens User Experience (CLUE™) questionnaire after approximately 1 week of lens wear. CLUE™ is a validated, patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable 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. A 5-point increase in an average CLUE™ score translates into 10% shift in the distribution of scores for population of soft contact lens. At the 1 week follow up
Secondary CLUE Handling score CLUE handling score will be assessed using the Contact Lens User Experience (CLUE™) questionnaire after approximately 1 week of lens wear. CLUE™ is a validated, patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable 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. A 5-point increase in an average CLUE™ score translates into 10% shift in the distribution of scores for population of soft contact lens. At the 1 week follow up
Secondary CLUE Comfort score CLUE comfort score will be assessed using the Contact Lens User Experience (CLUE™) questionnaire after approximately 1 week of lens wear. CLUE™ is a validated, patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable 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. A 5-point increase in an average CLUE™ score translates into 10% shift in the distribution of scores for population of soft contact lens. At the 1 week follow up
See also
  Status Clinical Trial Phase
Completed NCT06019806 - Effects of Forward Head Posture Correction on Visual Acuity in Low Level Visually Impaired University Students N/A
Completed NCT04567186 - Evaluation of a Daily Disposable Novel Multifocal Contact Lens in a Hyperopic Population N/A
Completed NCT02568254 - Evaluation of Three Daily Disposable Contact Lenses N/A
Completed NCT01951703 - Senofilcon A Investigational Manufacturing Process N/A
Terminated NCT00637468 - EAGLE - Multicenter Study of the European Assessment Group for Lysis in the Eye Phase 3
Recruiting NCT04632901 - A New Parameter for the Assessment of Distance Visual Capacity: the Critical Visual Acuity (CVA)
Active, not recruiting NCT03747601 - Temporal Interference Brain Stimulation N/A
Completed NCT06131476 - Clinical Investigation of Visual Acuity in Contact Lens Wearers After Instillation of a Lipid- Based Lubricating Eye Drop Phase 1
Recruiting NCT05414565 - Post-Market Study of Alcon Intraocular Lenses
Completed NCT05056870 - Clinical Evaluation of Spherical Soft Contact Lenses, Toric Soft Contact Lenses and Spectacles in Low Astigmats N/A
Completed NCT04615507 - Evaluation of a Daily Disposable Novel Multifocal Contact Lens in a Myopic Population; Part 2 N/A
Completed NCT05099380 - Validation of Senofilcon A With New UV / HEV Filter N/A
Completed NCT03713281 - Evaluation of a Toric Multifocal Contact Lens Manufactured in Etafilcon Material in a Low ADD Hyperopic Population
Completed NCT05582304 - Role of Glare and Spectral Filtering on Contrast Sensitivity: A Pilot Study N/A
Completed NCT03742271 - Evaluation of Senofilcon A With New UV-blocker on a Neophyte Population N/A
Completed NCT04995055 - Evaluation of Multifocal Contact Lens Designs With and Without an HEV Blocker on Visual Function N/A
Completed NCT05554640 - Clinical Performance of Two Daily Disposable Silicone Hydrogel Contact Lenses N/A
Completed NCT01926704 - MTF Image Modifications N/A
Completed NCT04649606 - Dynamic Characterisation of Meibomian Gland Structure
Completed NCT05101252 - Comparison of a Daily Disposable Multifocal Contact Lens to a Marketed Product N/A