Status:
COMPLETED
Clinical Study of Approved Contact Lenses
Lead Sponsor:
Bausch & Lomb Incorporated
Conditions:
Myopia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Evaluation of Johnson \& Johnson Acuvue Vita (senofilcon C) soft contact lenses to the Bausch + Lomb Ultra (samfilcon A) soft contact lenses
Detailed Description
to compare the performance of currently marketed Johnson \& Johnson Acuvue Vita (senofilcon C) soft contact lenses to the currently marketed Bausch + Lomb Ultra (samfilcon A) soft contact lenses among...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
October 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2017
Estimated Enrollment :
271 Patients enrolled
Trial Details
Trial ID
NCT03351101
Start Date
October 23 2017
End Date
December 8 2017
Last Update
January 8 2021
Active Locations (11)
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1
valeant Site 02
San Diego, California, United States, 92123
2
Valeant Site 03
San Francisco, California, United States, 94112
3
Valeant Site 04
Denver, Colorado, United States, 80246
4
Valeant Site 06
Orlando, Florida, United States, 32803