Contact Lenses for Visual Acuity Improvement
B+L Infuse spherical soft contact lenses
+ J&J ACUVUE OASYS 1-Day spherical soft contact lenses
Treatment Study
Summary
Study start date: September 11, 2025
Actual date on which the first participant was enrolled.This study aims to compare the effectiveness of two different brands of approved contact lenses in improving vision clarity. People who regularly wear contact lenses and are interested in finding the best option for visual acuity are the focus of this study. By understanding which lenses provide better visual outcomes, the study hopes to enhance everyday experiences for contact lens users who rely on them for clear vision. Participants in the study will wear each type of contact lens for three different periods, ensuring that results are not influenced by any single wearing experience. The study is designed to be "masked," meaning that participants will not know which brand of contact lens they are wearing at any given time, to ensure unbiased results. Throughout the study, visual acuity, or the clarity of vision, will be measured to determine which lenses perform better. There are no specified risks or benefits mentioned for the participants in the study information provided.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.85 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 39 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Potential subjects must satisfy all of 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 spherical soft silicone hydrogel 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\. Have a habitual contact lens prescription that is current (no power change needed) within the prior 6 months, and they must have worn that prescription for at least 2 weeks prior to entering the study. 6\. Possess a wearable pair of spectacles that provide correction for distance vision. 7\. The spherical equivalent of the subject's vertex-corrected distance refraction must be between -1.00 D and -6.00 D in each eye. 8\. The best corrected, monocular, distance visual acuity must be 20/25 or better in each eye. 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 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 that 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 a known hypersensitivity or allergic reaction to silicone hydrogel soft contact lenses. 8. Have participated in a contact lens or lens care product clinical trial within 14 days prior to study enrollment. 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 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). 11. Have a history of strabismus or amblyopia. 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 Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 4 locations
New Bremen EyeCare
New Bremen, United StatesBotetourt Eyecare LLC
Salem, United StatesNew River Vision Care
Oak Hill, United States