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

Not Applicable

Completed

• Conditions: Contact Lens Wearer
• Interventions: Device: samfilcon A Lenses with EPG01 Packaging Solution; Device: B+L Ultra Lenses

• Registration Number: NCT05126953
• Lead Sponsor: Bausch & Lomb Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-21
• Primary Completion: 2021-09-23
• Study Completion: 2021-09-23
• Status Verified: 2021-11
• Study First Submitted: 2021-11-10
• Study First Submitted QC: 2021-11-10
• Last Update Submitted: 2021-11-10
• Study First Posted: 2021-11-19
• Last Update Posted: 2021-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
samfilcon A Lenses with EPG01 Packaging Solution	samfilcon A Lenses with EPG01 Packaging Solution	-
B+L Ultra Lenses	B+L Ultra Lenses	-

Primary Outcome Measures

Name	Time	Method
Normalized logMAR Visual Acuity	2 hours

Trial Locations

Locations (1)

Bausch and Lomb Site 01; 🇺🇸 Rochester, New York, United States