Clinical Study of Approved Contact Lenses

Bausch + Lomb

Status: Completed

Conditions: Myopia

Treatments: Device: Senofilcon C; Device: Samfilcon A

Study type: Interventional

Funder types: Industry

Identifiers

NCT03351101

ROC2-17-014

Details and patient eligibility

About

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

Full 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 adapted wearers of Acuvue Oasys soft contact lenses.

Enrollment: 271 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 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.
2. 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.
3. Subjects must be willing and able to comply with all treatment and follow-up/study procedures.
4. Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
5. Subjects must have clear central corneas and be free of any anterior segment disorders.
6. 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).
7. Subjects must be habitual wearers of Johnson & Johnson Acuvue Oasys single vision spherical soft contact lenses in each eye.
8. Subjects must use a contact lens care regimen on a routine basis.
9. Subjects must agree to wear their study lenses on a daily wear basis for the duration

Exclusion criteria

1. 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

2. 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

3. 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.

4. Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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271 participants in 2 patient groups

Senofilcon C

Experimental group

Description:

Senofilcon C Contact Lens

Treatment:

Device: Senofilcon C

Samfilcon A

Experimental group

Description:

Samfilcon A Contact Lens

Treatment:

Device: Samfilcon A