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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03511638
Recruitment Status : Completed
First Posted : April 30, 2018
Results First Posted : October 22, 2021
Last Update Posted : October 22, 2021
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Study Description
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Brief Summary:
A Study to Document the Safety and Effectiveness of a New OVD When Compared to a Control OVD

Condition or disease Intervention/treatment Phase
Cataract Device: Bausch & Lomb DVisc40 Device: Alcon VISCOAT® Not Applicable

Detailed Description:
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®).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 372 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: a multicenter, controlled, randomized, monocular trial of Bausch & Lomb DVisc40 (test) OVD compared to the currently marketed Alcon VISCOAT® (control) OVD
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study to Document the Safety and Effectiveness of a New OVD When Compared to a Control OVD
Actual Study Start Date : May 9, 2018
Actual Primary Completion Date : April 1, 2019
Actual Study Completion Date : April 1, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Bausch & Lomb DVisc40
Ophthalmic viscosurgical device
 Device: Bausch & Lomb DVisc40
Ophthalmic viscosurgical device
Active Comparator: Alcon VISCOAT®
Ophthalmic viscosurgical device
 Device: Alcon VISCOAT®
Ophthalmic viscosurgical device


Outcome Measures
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Primary Outcome Measures :
  1. Percent Change in Mean Epithelial Cell Density (ECD) [ Time Frame: Day 90 ]
  2. Percentage of Participants With Postoperative Intraocular Pressure of at Least 30 mm Hg [ Time Frame: 90 days ]

Eligibility Criteria
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Ages Eligible for Study:   45 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03511638


Locations
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United States, California
Valeant Site 01
San Diego, California, United States, 22434
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
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Study Director: Anya Loncaric Bausch Health Americas, Inc.
  Study Documents (Full-Text)

Documents provided by Bausch & Lomb Incorporated:
Study Protocol and Statistical Analysis Plan  [PDF] January 3, 2019

More Information
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Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT03511638    
Other Study ID Numbers: S877
First Posted: April 30, 2018    Key Record Dates
Results First Posted: October 22, 2021
Last Update Posted: October 22, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases