A Safety and Effectiveness Study of a New Preservative Free Rewetting Drop

NCT ID: NCT04175340

Last Updated: 2024-07-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

369 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-07

Study Completion Date

2020-02-17

Brief Summary

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The objective of this study is to evaluate the safety and effectiveness of lubricating and rewetting drop (Test) compared to OPTI-FREE® Replenish® Rewetting Drops (Control) when used by habitual contact lens wearers to bilaterally lubricate and rewet soft (hydrophilic) contact lenses including silicone hydrogel contact lenses and gas permeable (silicone acrylate and fluoro silicone acrylate) contact lenses.

Detailed Description

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Conditions

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Contact Lens Wear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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BL-300-PFM04

Group Type EXPERIMENTAL

BL-300-PFM04

Intervention Type DEVICE

Preservative Free Lubricating and Rewetting Drops for use during contact lens wear

Lubricating and rewetting drops

Group Type ACTIVE_COMPARATOR

OPTI-FREE

Intervention Type DEVICE

Replenish Rewetting Drops

Interventions

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BL-300-PFM04

Preservative Free Lubricating and Rewetting Drops for use during contact lens wear

Intervention Type DEVICE

OPTI-FREE

Replenish Rewetting Drops

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects must be of legal age (at least 18) on the date the Informed Consent Form (ICF) is signed and have the capacity to provide voluntary informed consent
* Subjects must be habitual wearers of included contact lenses.
* Subjects must be adapted lens wearers and wear a lens in each eye and each lens must be of the same manufacture and brand.
* Subjects must agree to wear their lenses on a daily wear basis for approximately 1 month.

Exclusion Criteria

• Subjects participating in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bausch Site 108

San Francisco, California, United States

Site Status

Bausch Site 111

Torrance, California, United States

Site Status

Bausch Site 106

Sarasota, Florida, United States

Site Status

Bausch Site 104

Decatur, Georgia, United States

Site Status

Bausch Site 110

Bloomington, Kansas, United States

Site Status

Bausch Site 112

Leavenworth, Kansas, United States

Site Status

Bausch Site 107

Portland, Maine, United States

Site Status

Bausch Site 109

Edina, Minnesota, United States

Site Status

Bausch Site 102

Jamestown, New York, United States

Site Status

Bausch Site 113

Vestal, New York, United States

Site Status

Bausch Site 101

Miamisburg, Ohio, United States

Site Status

Bausch Site 105

West Chester, Ohio, United States

Site Status

Bausch Site 114

Grants Pass, Oregon, United States

Site Status

Bausch Site 115

Brentwood, Tennessee, United States

Site Status

Bausch Site 103

Nashville, Tennessee, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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952

Identifier Type: -

Identifier Source: org_study_id

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