Comparison of three daily disposable silicone hydrogel contact lenses

Clinical Performance of Three Daily Disposable Silicone Hydrogel Contact Lenses

This study tests how three different daily disposable contact lenses feel and help people see while they use digital devices.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 23 (estimated)
• Ages: 18 Years to 40 Years
• Sex: All
• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry-sponsored)
• Locations: 1 site (Manchester)
• Trial ID: NCT06778057 on ClinicalTrials.gov

What this trial studies

This clinical investigation evaluates the performance of three different types of daily disposable silicone hydrogel contact lenses in a randomized, subject-masked, bilateral crossover design. Participants will wear each lens type for a specified period, allowing for direct comparison of visual acuity and comfort. The study aims to gather data on how these lenses perform under typical usage conditions for individuals who frequently use digital devices.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 40 who regularly wear silicone hydrogel contact lenses and use digital devices for extended periods.

Not a fit: Patients who do not wear contact lenses or are outside the age range of 18 to 40 may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved options for contact lens wearers, enhancing visual comfort and acuity.

How similar studies have performed: Previous studies have shown promising results in comparing different types of contact lenses, suggesting that this approach is supported by existing research.

Eligibility 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 40 (inclusive) years of age at the time of screening.
4. By self-report, they typically use digital devices for a minimum of 4 hours per day, 5 days per week.
5. In a pre-study screening assessment, they must have a CVS-Q score of 6 or greater.
6. Agree not to participate in other clinical research while enrolled on this study.
7. Own a wearable pair of spectacles, if needed, for distance vision correction (by self-report).
8. By self-report, habitually wear 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 8 hours of wear per day, for at least 4 days per week over the past 4 weeks.
9. Attain a best-corrected logMAR distance visual acuity of at least 0.20 in each eye.
10. Have spherical contact lens prescription in the range -1.00 to -6.00 DS (based on the calculated ocular refraction) in each eye.
11. Have up to a maximum of 1.00 DC of refractive astigmatism (based on the calculated ocular refraction) 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. By self-report, have any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g. hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g., rheumatoid arthritis), or other diseases, which in the opinion of the investigator is likely to interfere with contact lens wear and/or participation in the study or may pose a risk to study personnel.
3. Have an ocular disorder which would normally contraindicate contact lens wear.
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 or have had worn Acuvue® Oasys 1-Day, Dailies® Total1, or Clariti 1-Day lenses during the last 3 months.
7. Have had cataract surgery.
8. Have had corneal refractive surgery.
9. Be using any topical medications such as eye drops or ointments.
10. Have a known hypersensitivity or allergic reaction to sodium fluorescein.
11. Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear. See section 9.1 for additional details regarding excluded systemic medications.
12. Participation in any contact lens or lens care product clinical trial within 2 weeks prior to study enrolment
13. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
14. Have clinically significant (grade 3 or higher on the Efron 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 in the opinion of the investigator would 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).
15. Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.
16. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.

Where this trial is running

Manchester

• The University of Manchester, Department of Optometry & Neuroscience — Manchester, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Study Contact

Conditions Visual Acuity