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

NCT ID: NCT05129488

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-15
• Study Completion Date: 2021-09-20

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.

Conditions

Contact Lens Wearer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffery Schafer, OD

Role: PRINCIPAL_INVESTIGATOR

Bausch & Lomb Incorporated

Locations

Bausch and Lomb Site 01

Rochester, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

21-005

Identifier Type: -

Identifier Source: org_study_id