2-Hour Dispensing Evaluation of Samfilcon A Lenses With EPG01 Packaging Solution Compared to Commercially Available B+L Ultra Lenses

The objective of this 2 hour study is to evaluate the clinical performance of samfilcon A lenses with an alternate packaging solution (EPG01) compared to commercially available B+L Ultra lenses.

Study Overview

• Status: Completed
• Conditions: Contact Lens Wearer
• Intervention / Treatment: Device: samfilcon A Lenses with EPG01 Packaging Solution; Device: Commercially Available B+L Ultra Lenses

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14609
      • Bausch and Lomb Site 01

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have capacity to read, understand and provide written voluntary informed consent.
2. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
3. Have no active ocular disease or allergic conjunctivitis.
4. Not be using any topical ocular medications.
5. Be willing and able to follow instructions.
6. Have signed a statement of informed consent.

Exclusion Criteria:

1. Participating in a conflicting study in the opinion of the Investigator.
2. Considered by the Investigator to not be a suitable candidate for participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Samfilcon A Lenses with EPG01 Packaging Solution; Subjects implanted with Samfilcon A Lenses with EPG01 Packaging Solution	Device: samfilcon A Lenses with EPG01 Packaging Solution; samfilcon A Lenses with EPG01 Packaging Solution
Active Comparator: Commercially Available B+L Ultra Lenses; Subjects implanted with Commercially Available B+L Ultra Lenses	Device: Commercially Available B+L Ultra Lenses; Commercially Available B+L Ultra Lenses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Normalized logMAR Visual Acuity	Normalized logMAR visual acuity is the change in visual acuity (how well you can see) from baseline (spectacle). Normalized visual acuity is calculated by subtracting the logMAR visual acuity with a contact lens from the baseline (refraction without a contact lens). Each letter on the logMAR visual acuity chart has a value of 0.02.	Assessed at 2-hour post-baseline

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Principal Investigator: Jeffery Schafer, OD, Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2021
• Primary Completion (Actual): September 23, 2021
• Study Completion (Actual): September 23, 2021

Study Registration Dates

• First Submitted: November 10, 2021
• First Submitted That Met QC Criteria: November 10, 2021
• First Posted (Actual): November 19, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2025
• Last Update Submitted That Met QC Criteria: July 1, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 21-003

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