NCT03511638

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 372 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 45 Years – 99 Years
• Healthy volunteers: Not accepted

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®).

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	Bausch & Lomb DVisc40	Ophthalmic viscosurgical device
DEVICE	Alcon VISCOAT®	Ophthalmic viscosurgical device

Timeline

• Start date: 2018-05-09
• Primary completion: 2019-04-01
• Completion: 2019-04-01
• First posted: 2018-04-30
• Last updated: 2021-10-22
• Results posted: 2021-10-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study