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

Bausch + Lomb

Status: Completed

Conditions: Contact Lens Wearer

Treatments: Device: Commercially Available B+L Ultra Lenses; Device: samfilcon A Lenses with EPG01 Packaging Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT05126953

21-003

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Samfilcon A Lenses with EPG01 Packaging Solution

Experimental group

Description:

Subjects implanted with Samfilcon A Lenses with EPG01 Packaging Solution

Treatment:

Device: samfilcon A Lenses with EPG01 Packaging Solution

Commercially Available B+L Ultra Lenses

Active Comparator group

Description:

Subjects implanted with Commercially Available B+L Ultra Lenses

Treatment:

Device: Commercially Available B+L Ultra Lenses