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

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Device: Bausch & Lomb DVisc40; Device: Alcon VISCOAT®

• Registration Number: NCT03511638
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-11-17
• Study First Submitted QC: 2018-04-26
• Study First Posted: 2018-04-30
• Study Start: 2018-05-09
• Primary Completion: 2019-04-01
• Study Completion: 2019-04-01
• Disposition First Submitted: 2019-10-23
• Disposition First Submitted QC: 2019-10-23
• Disposition First Posted: 2019-11-05
• Status Verified: 2021-09
• Results First Submitted: 2021-09-24
• Results First Submitted QC: 2021-09-24
• Last Update Submitted: 2021-09-24
• Results First Posted: 2021-10-22
• Last Update Posted: 2021-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 372

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bausch & Lomb DVisc40	Bausch & Lomb DVisc40	Ophthalmic viscosurgical device
Alcon VISCOAT®	Alcon VISCOAT®	Ophthalmic viscosurgical device

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Valeant Site 01; 🇺🇸 San Diego, California, United States