2-Hour Dispensing Evaluation of Samfilcon A Lenses With EPG01 Packaging Solution Compared to Commercially Available B+L Ultra Lenses

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-21

Study Completion Date

2021-09-23

Brief Summary

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The objective of this 2 hour study is to evaluate the clinical performance of samfilcon A lenses with an alternate packaging solution (EPG01) compared to commercially available B+L Ultra lenses.

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Detailed Description

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Conditions

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Contact Lens Wearer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Samfilcon A Lenses with EPG01 Packaging Solution

Subjects implanted with Samfilcon A Lenses with EPG01 Packaging Solution

Group Type EXPERIMENTAL

samfilcon A Lenses with EPG01 Packaging Solution

Intervention Type DEVICE

samfilcon A Lenses with EPG01 Packaging Solution

Commercially Available B+L Ultra Lenses

Subjects implanted with Commercially Available B+L Ultra Lenses

Group Type ACTIVE_COMPARATOR

Commercially Available B+L Ultra Lenses

Intervention Type DEVICE

Commercially Available B+L Ultra Lenses

Interventions

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samfilcon A Lenses with EPG01 Packaging Solution

Intervention Type DEVICE

Commercially Available B+L Ultra Lenses

Intervention Type DEVICE

Eligibility Criteria

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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