Clinical Study of Approved Contact Lenses

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

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Senofilcon C; Device: Samfilcon A

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.

• Study Type: Interventional
• Enrollment (Actual): 271
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Valeant Site 02
    • San Francisco, California, United States, 94112
      • Valeant Site 03
  • Colorado
    • Denver, Colorado, United States, 80246
      • Valeant Site 04
  • Florida
    • Orlando, Florida, United States, 32803
      • Valeant Site 06
    • Orlando, Florida, United States, 32812
      • Valeant Site 01
    • Sarasota, Florida, United States, 34232
      • Valeant Site 05
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Valeant Site 07
  • Missouri
    • Warrensburg, Missouri, United States, 64093
      • Valeant Site 08
  • New York
    • Vestal, New York, United States, 13850
      • Valeant Site 09
  • Ohio
    • Powell, Ohio, United States, 43065
      • Valeant Site 10
  • Wisconsin
    • New Berlin, Wisconsin, United States, 53151
      • Valeant Site 11

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Senofilcon C; Senofilcon C Contact Lens	Device: Senofilcon C; Senofilcon C Contact Lens
Experimental: Samfilcon A; Samfilcon A Contact Lens	Device: Samfilcon A; Samfilcon A Contact Lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
End of Day Comfort	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.	1 month
Overall Vision	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.	1 month

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2017
• Primary Completion (Actual): November 10, 2017
• Study Completion (Actual): December 8, 2017

Study Registration Dates

• First Submitted: November 9, 2017
• First Submitted That Met QC Criteria: November 20, 2017
• First Posted (Actual): November 22, 2017

Study Record Updates

• Last Update Posted (Actual): January 8, 2021
• Last Update Submitted That Met QC Criteria: January 6, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: ROC2-17-014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes