Clinical Performance Assessment of Two Silicone Hydrogel Daily Disposable Contact 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

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-02

Study Completion Date

2023-06-27

Brief Summary

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The purpose of this study is to assess the overall clinical performance of a contact lens made with a modified manufacturing process.

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Detailed Description

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The expected duration of subject participation in the study is approximately 4 days with 2 scheduled visits.

Conditions

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Refractive Errors Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LID220365 (OD) / LID006961 (OS)

LID220365 contact lens worn in the right eye (OD), with LID006961 contact lens worn in the left eye (OS), as randomized, for four days. A fresh pair of lenses will be worn each day.

Group Type OTHER

LID220365 contact lens

Intervention Type DEVICE

Investigational delefilcon A spherical contact lens made with a modified manufacturing process

LID006961 contact lens

Intervention Type DEVICE

Commercially available delefilcon A spherical contact lens

LID006961 (OD) / LID220365 (OS)

LID006961 contact lens worn in the right eye (OD), with LID220365 contact lens worn in the left eye (OS), as randomized, for four days. A fresh pair of lenses will be worn each day.

Group Type OTHER

LID220365 contact lens

Intervention Type DEVICE

Investigational delefilcon A spherical contact lens made with a modified manufacturing process

LID006961 contact lens

Intervention Type DEVICE

Commercially available delefilcon A spherical contact lens

Interventions

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LID220365 contact lens

Investigational delefilcon A spherical contact lens made with a modified manufacturing process

Intervention Type DEVICE

LID006961 contact lens

Commercially available delefilcon A spherical contact lens

Intervention Type DEVICE

Other Intervention Names

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DAILIES TOTAL1®

Eligibility Criteria

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Inclusion Criteria

* Successful wearer of spherical soft contact lenses of the same brand in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
* Manifest cylinder equal to or less than 0.75 diopter (D) in each eye.
* Best corrected visual acuity (BCVA) better than or equal to 0.10 logMAR in each eye.

Exclusion Criteria

* Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during study participation.
* Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
* Habitual monovision or multifocal contact lens wearers.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No