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

NCT03511638 | Completed Results DMC FDA Device

• 1 other identifier: S877
• Study Type: interventional
• Target: 372
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cataract

Outcome Measures

Primary Outcomes (2)

• Percent Change in Mean Epithelial Cell Density (ECD)

  Day 90

• Percentage of Participants With Postoperative Intraocular Pressure of at Least 30 mm Hg

  90 days

Study Arms (2)

Bausch & Lomb DVisc40

EXPERIMENTAL

Ophthalmic viscosurgical device

Device: Bausch & Lomb DVisc40

Alcon VISCOAT®

ACTIVE COMPARATOR

Ophthalmic viscosurgical device

Device: Alcon VISCOAT®

Interventions

Bausch & Lomb DVisc40 DEVICE

Ophthalmic viscosurgical device

Bausch & Lomb DVisc40

Alcon VISCOAT® DEVICE

Ophthalmic viscosurgical device

Alcon VISCOAT®

Eligibility Criteria

• Age: 45 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \. 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.
• \. 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.

You may not qualify if:

• \. 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.
• \. The subject has any corneal pathology (e.g., significant scarring, guttata, inflammation, edema, dystrophy, etc.) in the operative eye.
• \. 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.
• \. The subject has any condition which prevents reliable specular microscopy in the operative eye.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Valeant Site 01

San Diego, California, 22434, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Study Director
• Organization: Bausch & Lomb

aloncaric@bauschhealth.com

510-259-5284

Study Officials

• Anya Loncaric

  Bausch Health Americas, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: April 30, 2018
• Study Start: May 9, 2018
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: October 22, 2021
• Results First Posted: October 22, 2021

Record last verified: 2021-09

Locations

US (1)