MedPath

Clinical Study of Approved Contact Lenses

Not Applicable
Completed
Conditions
Myopia
Interventions
Device: Senofilcon C
Device: Samfilcon A
Registration Number
NCT03351101
Lead Sponsor
Bausch & Lomb Incorporated
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 adapted wearers of Acuvue Oasys soft contact lenses.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
271
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Senofilcon CSenofilcon CSenofilcon C Contact Lens
Samfilcon ASamfilcon ASamfilcon A Contact Lens
Primary Outcome Measures
NameTimeMethod
End of Day Comfort1 month

The 100 point , take home questionnaire evaluated performance of the lenses based on subject responses. Possible scores were 0-100. Higher scores indicated greater comfort.

Overall Vision1 month

The 100 point , take home questionnaire evaluated performance of the lenses based on subject responses. Possible scores were 0-100. Higher scores indicated better overall vision.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (11)

Valeant Site 04

🇺🇸

Denver, Colorado, United States

valeant Site 02

🇺🇸

San Diego, California, United States

Valeant Site 03

🇺🇸

San Francisco, California, United States

Valeant Site 06

🇺🇸

Orlando, Florida, United States

Valeant Site 08

🇺🇸

Warrensburg, Missouri, United States

Valeant Site 07

🇺🇸

Pittsburg, Kansas, United States

Valeant Site 01

🇺🇸

Orlando, Florida, United States

Valeant Site 05

🇺🇸

Sarasota, Florida, United States

Valeant Site 10

🇺🇸

Powell, Ohio, United States

Valeant Site 09

🇺🇸

Vestal, New York, United States

Valeant Site 11

🇺🇸

New Berlin, Wisconsin, United States

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