Clinical Study of Approved Contact Lenses

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

271 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-23

Study Completion Date

2017-12-08

Brief Summary

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

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Detailed Description

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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.

Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized, bilateral, d o u b l e - masked, 1-month study with two parallel groups

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Senofilcon C

Senofilcon C Contact Lens

Group Type EXPERIMENTAL

Senofilcon C

Intervention Type DEVICE

Senofilcon C Contact Lens

Samfilcon A

Samfilcon A Contact Lens

Group Type EXPERIMENTAL

Samfilcon A

Intervention Type DEVICE

Samfilcon A Contact Lens

Interventions

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Senofilcon C

Senofilcon C Contact Lens

Intervention Type DEVICE

Samfilcon A

Samfilcon A Contact Lens

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes