Biotrue ONEday Contact Lenses With EPG03 Packaging Solution Compared to Biotrue ONEday Contact Lenses

Not Applicable

Completed

• Conditions: Contact Lens Wearer

• Registration Number: NCT05129488
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

The objective of this 2 hour study is to evaluate the clinical performance of Biotrue ONEday lenses with an alternate packaging solution (EPG03) compared to commercially available Biotrue ONEday lenses. This novel contact lens packaging solution contains known elements in the ophthalmic industry and is safe for use.

Detailed Description

Approximately 30 habitual soft contact lens wearing subjects will be enrolled in this two-hour randomized, contralateral, double-masked (subject and investigator masked), repeated measures dispensing study. All subjects will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If subjects satisfy all eligibility criteria and none of the exclusion criteria, subjects will be dispensed study lenses according to unique randomization schedules that will be provided to each Investigator.

Study Timeline

• Study Start: 2021-09-15
• Primary Completion: 2021-09-20
• Study Completion: 2021-09-20
• Study First Submitted: 2021-11-10
• Study First Submitted QC: 2021-11-10
• Study First Posted: 2021-11-22
• Status Verified: 2022-11
• Results First Submitted: 2022-11-14
• Results First Submitted QC: 2024-03-19
• Last Update Submitted: 2024-03-19
• Results First Posted: 2024-04-16
• Last Update Posted: 2024-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Normalized logMAR Visual Acuity	2 hours	logMAR visual acuity typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. 0.02 is considered 1 letter on the chart Normalized logMAR VA is a change from baseline measurement. It is calculated by taking the logMAR VA from the baseline refraction (No contact lens) and subtracting the logMAR VA with the contact lens.

Trial Locations

Locations (1)

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