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Bausch & Lomb Ophthalmic Viscosurgical Device (OVD) Dispersive (DVisc40)

NCT ID: NCT03511638

Last Updated: 2021-10-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

372 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-09

Study Completion Date

2019-04-01

Brief Summary

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A Study to Document the Safety and Effectiveness of a New OVD When Compared to a Control OVD

Detailed Description

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This is a multicenter, controlled, randomized, monocular trial evaluating the safety and effectiveness of the Bausch \& Lomb DVisc40 dispersive OVD compared to the Alcon VISCOAT® dispersive OVD when used in cataract surgery. Subjects will be randomized to one of the two treatment groups in a 1:1 ratio (DVisc40:VISCOAT®).

Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

a multicenter, controlled, randomized, monocular trial of Bausch \& Lomb DVisc40 (test) OVD compared to the currently marketed Alcon VISCOAT® (control) OVD
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Bausch & Lomb DVisc40

Ophthalmic viscosurgical device

Group Type EXPERIMENTAL

Bausch & Lomb DVisc40

Intervention Type DEVICE

Ophthalmic viscosurgical device

Alcon VISCOAT®

Ophthalmic viscosurgical device

Group Type ACTIVE_COMPARATOR

Alcon VISCOAT®

Intervention Type DEVICE

Ophthalmic viscosurgical device

Interventions

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Bausch & Lomb DVisc40

Ophthalmic viscosurgical device

Intervention Type DEVICE

Alcon VISCOAT®

Ophthalmic viscosurgical device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* The subject must be at least 45 years old and have a clinically documented diagnosis of age-related non-complicated cataract that is considered amenable to treatment with standard phacoemulsification cataract extraction and IOL implantation.

2\. The subject must have the capability to provide written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved Informed Consent Form (ICF) and provide authorization as appropriate for local privacy regulations.

3\. The subject must be willing and able to return for all scheduled follow-up examinations through 90 days following surgery.

Study #877 Protocol DVisc40 28JUL2017 V1.0 CONFIDENTIAL Page 16 of 53 4. The subject must have clear intraocular media other than the cataract in the operative eye.

Exclusion Criteria

* 1\. The subject has participated in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation.

2\. The subject has any corneal pathology (e.g., significant scarring, guttata, inflammation, edema, dystrophy, etc.) in the operative eye.

3\. The subject has anterior segment pathology likely to increase the risk of an adverse outcome for phacoemulsification cataract surgery (e.g., pseudoexfoliation syndrome, synechiae, iris atrophy, inadequate dilation, shallow anterior chamber, traumatic cataract, lens subluxation) in the operative eye.

4\. The subject has any condition which prevents reliable specular microscopy in the operative eye.
Minimum Eligible Age

45 Years

Maximum Eligible Age

99 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

Principal Investigators

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Anya Loncaric

Role: STUDY_DIRECTOR

Bausch Health Americas, Inc.

Locations

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Valeant Site 01

San Diego, California, 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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S877

Identifier Type: -

Identifier Source: org_study_id