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

Bausch + Lomb

Status: Completed

Conditions: Contact Lens Wearer

Treatments: Device: All participants received Biotrue ONEday lenses with and without an alternate packaging solution (EPG03)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05129488

21-005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 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: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

All participants received Biotrue ONEday lenses with and without an alternate packaging solution

Experimental group

Description:

Participants were given both Commercially available Biotrue ONEday lenses and Biotrue ONEday Contact Lenses with EPG03 Packaging Solution. Lens material is made from a hydrophilic copolymer of 2- hydroxyethyl methacrylate and N-vinylpyrrolidone and is 78% water by weight when immersed in saline solution. EPG03 Packaging Solution contains a phosphate buffered saline solution containing potassium chloride, poloxamine, poloxamer 181, glycerol (glycerin), erythritol, and polyquaternium-1.

Treatment:

Device: All participants received Biotrue ONEday lenses with and without an alternate packaging solution (EPG03)