| Eligibility |
Inclusion Criteria:
1. 18 to 40 years of age on the date the informed consent form (ICF) is signed
2. Presence of clear central corneas and absence of any anterior segment disorders in
each eye
3. Presence of myopia and requirement for lens correction from -1.00 D to -6.00 D in each
eye
4. Best-corrected distance visual acuity (BCDVA) of 50 ETDRS letters (0.1 logMAR) or
better in each eye
5. Be an adapted soft contact lens wearer in each eye and agree to wear study lenses in
each eye on a daily wear basis and not wear a non-study lens for approximately 3
months
6. Able and willing to comply with all treatment and follow-up/study procedures
7. Able to read, understand, and provide written informed consent on the IRB-approved ICF
and provide authorization as appropriate for local privacy regulations
Exclusion Criteria:
1. Participation in any drug or device clinical investigation within 2 weeks prior to
Screening and/or during the period of study participation
2. Women of childbearing potential (those who are not surgically sterilized or
postmenopausal) who meet any of the following conditions:
1. Currently pregnant
2. Plans to become pregnant during the study
3. Currently breastfeeding
3. History of gas permeable lens wear in either eye within 30 days prior to Screening or
history of polymethylmethacrylate lens wear in either eye within 3 months prior to
Screening
4. Current monovision, multifocal, or toric contact lens wear in either eye
5. In either eye, current nonabsorbable punctal plug or implantation of absorbable
punctal plug within 2 to 6 months (depending on type of absorbable plug) prior to
Screening, or punctal plug removal within 2 months prior to Screening. Permanent
punctal occlusion in 1 or more puncta or nasolacrimal duct obstruction in either eye
is excluded
6. Use of any prescription ocular medication throughout the duration of the study.
Prescription eyedrops for dry eye disease (eg, Restasis, Xiidra, Cequa, Eysuvis), as
well as nasally administered Tyrvaya, must be discontinued 2 weeks prior to Screening
and are prohibited throughout the duration of the study Clinical Study Protocol
Version 3.0, 26 April 2023 Page 17 of 66 Bruno Vision Care Protocol 22001
7. Use of over-the-counter eyedrops (eg, oxymetazoline, naphazoline, ketotifen, etc.),
except for unpreserved lubricant eyedrops or artificial tears (eg, Systane, Refresh),
within 1 week prior to Screening and throughout the duration of the study
8. Use of any systemic or topical medications that may, in the Investigator's opinion,
affect ocular physiology or lens performance
9. Anisometropia (spherical equivalent) >2.00 D
10. Ocular astigmatism >1.00 D in either eye
11. Amblyopia in either eye
12. Aphakia in either eye
13. Active ocular disease (eg, dry eye disease, blepharitis, conjunctivitis, keratitis,
etc.) in either eye. Subjects must be symptom free for at least 7 days
14. History or evidence of ocular infection within 30 days prior to Screening
15. History or evidence of ocular herpes simplex or ocular herpes zoster
16. Any grade corneal infiltrates in either eye
17. Grade =2 finding in either eye during slit lamp examination
18. Any "Present" finding in either eye during slit lamp examination that, in the
Investigator's opinion, may interfere with contact lens wear
19. Any scar or neovascularization within the central 4 mm of the cornea in either eye.
Subjects with minor peripheral corneal scarring (not extending into the central area)
that, in the Investigator's opinion, does not interfere with contact lens wear are
eligible to participate in this study
20. History of any corneal surgery (eg, refractive surgery or therapeutic) in either eye
21. Any systemic disease currently affecting ocular health or which, in the Investigator's
opinion, may have an effect on ocular health in either eye during the course of the
study
22. Allergy to any component in the study care products
23. Meet any of the following criteria:
1. Subject is an employee of the investigative site
2. Subject or a member of the subject's household is an ophthalmologist, an
optometrist, an optician, or an ophthalmic assistant/technician
3. Subject or a member of the subject's household is an employee of a manufacturer
of contact lenses or contact lens care products
4. Subject or a member of the subject's household is an employee of a market
research firm -
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