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OpenTrials
Completed

NCT Number: NCT05129488

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

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.

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Key information

Conditions

Contact Lens Wearer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bausch and Lomb Site 01

Rochester, New York, 14609, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
  • Have no active ocular disease or allergic conjunctivitis.
  • Not be using any topical ocular medications.
  • Be willing and able to follow instructions.
  • Have signed a statement of informed consent.

Exclusion criteria

  • Participating in a conflicting study in the opinion of the Investigator.
  • Considered by the Investigator to not be a suitable candidate for participation.

Treatment and study plan

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

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.

Primary outcomes

  1. Normalized logMAR Visual Acuity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 22, 2021
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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