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

NCT05126953 | Completed Results FDA Device

• 1 other identifier: 21-003
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Contact Lens Wearer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Samfilcon A Lenses with EPG01 Packaging Solution

EXPERIMENTAL

Subjects implanted with Samfilcon A Lenses with EPG01 Packaging Solution

Device: samfilcon A Lenses with EPG01 Packaging Solution

Commercially Available B+L Ultra Lenses

ACTIVE COMPARATOR

Subjects implanted with Commercially Available B+L Ultra Lenses

Device: Commercially Available B+L Ultra Lenses

Interventions

samfilcon A Lenses with EPG01 Packaging Solution DEVICE

samfilcon A Lenses with EPG01 Packaging Solution

Samfilcon A Lenses with EPG01 Packaging Solution

Commercially Available B+L Ultra Lenses DEVICE

Commercially Available B+L Ultra Lenses

Commercially Available B+L Ultra Lenses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
• Have no active ocular disease or allergic conjunctivitis.
• Not be using any topical ocular medications.
• Be willing and able to follow instructions.
• Have signed a statement of informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Bausch and Lomb Site 01

Rochester, New York, 14609, United States

Location

Results Point of Contact

• Title: Schafer, Jill
• Organization: Bausch + Lomb Incorporated

Jill.Schafer@bausch.com

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Study Officials

• Jeffery Schafer, OD

  Bausch & Lomb Incorporated

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: November 19, 2021
• Study Start: September 21, 2021
• Primary Completion: September 23, 2021
• Study Completion: September 23, 2021
• Last Updated: July 20, 2025
• Results First Posted: July 20, 2025

Record last verified: 2025-07

Locations

US (1)