Clinical Study of Approved Contact Lenses

Completed · Not applicable

Conditions studied: Myopia

In brief

Evaluation of Johnson \& Johnson Acuvue Vita (senofilcon C) soft contact lenses to the Bausch + Lomb Ultra (samfilcon A) soft contact lenses

Key facts

Study ID

NCT03351101

Run by

Bausch & Lomb Incorporated

People needed

271

Starts

2017-10-23

Expected to finish

2017-12-08

Last updated by the study team

2021-01-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects must be between the ages of 18 and 40 years old, inclusive, on the date the Informed Consent Form (ICF) is signed and have the capacity to provide voluntary informed consent.
• Subjects must be able to read, understand and provide written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and provide authorization as appropriate for local privacy regulations.
• Subjects must be willing and able to comply with all treatment and follow-up/study procedures.
• Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
• Subjects must have clear central corneas and be free of any anterior segment disorders.
• Subjects must be myopic and require contact lens sphere power correction from -0.50 diopter (D) to -6.00 D (considering vertex distance adjustments in both eyes).
• Subjects must be habitual wearers of Johnson \& Johnson Acuvue Oasys single vision spherical soft contact lenses in each eye.
• Subjects must use a contact lens care regimen on a routine basis.
• Subjects must agree to wear their study lenses on a daily wear basis for the duration

You may not qualify if…

• Subjects participating in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation
• Subjects who are women of childbearing potential (those who are not surgically sterilized or postmenopausal) are excluded from participation in the investigation if they meet any one of the following conditions:
• she is currently pregnant
• she plans to become pregnant during the study
• she is breastfeeding
• Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
• Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.

Where it is running

• valeant Site 02 — San Diego, California, United States
• Valeant Site 03 — San Francisco, California, United States
• Valeant Site 04 — Denver, Colorado, United States
• Valeant Site 06 — Orlando, Florida, United States
• Valeant Site 01 — Orlando, Florida, United States
• Valeant Site 05 — Sarasota, Florida, United States
• Valeant Site 07 — Pittsburg, Kansas, United States
• Valeant Site 08 — Warrensburg, Missouri, United States
• Valeant Site 09 — Vestal, New York, United States
• Valeant Site 10 — Powell, Ohio, United States
• Valeant Site 11 — New Berlin, Wisconsin, United States

Full record on ClinicalTrials.gov

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