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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03511638
• Other study ID #: S877
• Status: Completed
• Phase: N/A
• Start date: May 9, 2018
• Est. completion date: April 1, 2019

Study information

• Verified date: September 2021
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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®).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 372
• Est. completion date: April 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Bausch & Lomb DVisc40
Ophthalmic viscosurgical device
• Alcon VISCOAT®
Ophthalmic viscosurgical device

Locations

Country	Name	City	State
United States	Valeant Site 01	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in Mean Epithelial Cell Density (ECD)		Day 90
Primary	Percentage of Participants With Postoperative Intraocular Pressure of at Least 30 mm Hg		90 days