NCT05129488

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

2 Hour Dispensing Evaluation of Biotrue ONEday Contact Lenses With EPG03 Packaging Solution Compared to Commercially Available Biotrue ONEday Contact Lenses

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Contact Lens Wearer

Interventions

Type	Name	Description
DEVICE	All participants received Biotrue ONEday lenses with and without an alternate packaging solution (EPG03)	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.

Timeline

• Start date: 2021-09-15
• Primary completion: 2021-09-20
• Completion: 2021-09-20
• First posted: 2021-11-22
• Last updated: 2024-04-16
• Results posted: 2024-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study