Trial Outcomes & Findings for Biotrue ONEday Contact Lenses With EPG03 Packaging Solution Compared to Biotrue ONEday Contact Lenses (NCT NCT05129488)

NCT ID: NCT05129488

Last Updated: 2024-04-16

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 33 participants
• Primary outcome timeframe: 2 hours
• Results posted on: 2024-04-16

Participant Flow

Unit of analysis: Eyes

Participant milestones

Measure	All Participants Received Biotrue ONEday Lenses With and Without an Alternate Packaging Solution 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.
Overall Study STARTED	33 66
Overall Study Contact Lenses With Solution	30 60
Overall Study Contact Lenses Without Solution	30 60
Overall Study COMPLETED	30 60
Overall Study NOT COMPLETED	3 6

Reasons for withdrawal

Measure

All Participants Received Biotrue ONEday Lenses With and Without an Alternate Packaging Solution 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.

Overall Study Protocol Violation

3

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Participants Received Biotrue ONEday Lenses With and Without an Alternate Packaging Solution (EPG03) n=60 Eyes 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.
Age, Continuous	41.7 years STANDARD_DEVIATION 12.52 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Biotrue ONEday Lenses With an Alternate Packaging Solution (EPG03) n=30 Participants 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.	Biotrue ONEday Lenses n=30 Participants Biotrue ONEday lenses: Commercially available Biotrue ONEday lenses
Normalized logMAR Visual Acuity	-0.01 LogMAR Standard Deviation 0.070	-0.02 LogMAR Standard Deviation 0.109

Adverse Events

Biotrue ONEday Contact Lenses With EPG03 Packaging Solution

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Biotrue ONEday Contact Lenses

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Study Director

Bausch & Lomb

Phone: 15853386399

Email: robert.steffen@bausch.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place