A Study of B + L Ophthalmic Viscosurgical Device (OVD) CVisc50

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04192630
• Other study ID #: 878
• Status: Completed
• Phase: N/A
• Start date: November 26, 2019
• Est. completion date: January 31, 2022

Study information

• Verified date: December 2022
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the study is to evaluate the safety and effectiveness of the Bausch & Lomb CVisc50 cohesive OVD compared to the Alcon ProVisc® cohesive OVD when used in cataract surgery.

Description:

The objective of the study is to evaluate the safety and effectiveness of the Bausch & Lomb CVisc50 cohesive OVD compared to the Alcon ProVisc® cohesive OVD when used in cataract surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 390
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• The participant 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 participant 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 participant must be willing and able to undergo all pre-surgical and surgical procedures and to return for all scheduled follow-up examinations through 90 days following surgery.

• The participant must have clear intraocular media other than the cataract in the operative eye.

Exclusion Criteria:

• The participant has participated in any drug or device clinical investigation within 30 days prior to entry into this study and/or plans to do so during the period of study participation.

• The participant has any corneal pathology (for example; significant scarring, guttata, inflammation, edema, dystrophy, etc.) in the operative eye.

• The participant has anterior segment pathology likely to increase the risk of an adverse outcome for phacoemulsification cataract surgery (for example; pseudoexfoliation syndrome, synechiae, iris atrophy, inadequate dilation, shallow anterior chamber, traumatic cataract, lens subluxation) in the operative eye.

• The participant has any condition which prevents reliable specular microscopy in the operative eye.

• The participant has a congenital ocular anomaly (for example; aniridia, congenital cataract) in the operative eye.

• The participant has a baseline ECD <1500 cells/square millimeter (mm^2) in the operative eye.

• The participant has a grade 4+ nuclear cataract density in the planned operative eye.

• The participant has glaucoma or ocular hypertension (IOP >24 mmHg) in the operative eye.

• The participant has any abnormality which prevents reliable Goldmann applanation tonometry in the operative eye.

• The participant has a known allergy to any of the components of the test or control OVDs.

• The participant is using any topical or systemic medications known to interfere with visual performance or complicate cataract surgery within 30 days of enrollment or during the study.

• The participant is scheduled to undergo other combined intraocular procedures during the cataract/intraocular lens (IOL) implantation surgery in the operative eye. NOTE: A relaxing keratotomy is allowed.

• The participant has diabetic retinopathy, wet age-related macular degeneration or other retinal pathology which might limit postoperative visual acuity (VA) or predispose the participant to postoperative retinal complications in the operative eye.

• The participant's fellow eye is already participating in this study.

• The participant has a history of chronic or recurrent inflammatory eye disease (for example; iritis, scleritis, uveitis, iridocyclitis, rubeosis iridis) in the operative eye.

• The participant has a best corrected distance visual acuity (BCDVA) of logarithm of minimum angle resolution (LogMAR) 1.0 (20/200, 6/60) or worse in the fellow eye.

• The participant has had previous corneal surgery in the planned operative eye.

• The participant has a previous retinal detachment in the operative eye.

• Females of childbearing potential (those who are not surgically sterilized or not postmenopausal for at least 12 months) are excluded from participation in the study if they are currently pregnant; plan to become pregnant during the study; and/or are breast-feeding.

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• CVisc50 OVD
Bausch + Lomb CVisc50 Cohesive OVD
• ProVisc OVD
ProVisc OVD

Procedure:
• Cataract Surgery
Cataract Surgery

Locations

Country	Name	City	State
United States	Bausch Site 019	Bloomington	Minnesota
United States	Bausch Site 010	Burlingame	California
United States	Bausch Site 009	Cedar Park	Texas
United States	Bausch Site 017	Chandler	Arizona
United States	Bausch Site 008	Fayetteville	Arkansas
United States	Bausch Site 007	Garden Grove	California
United States	Bausch Site 014	Goodlettsville	Tennessee
United States	Bausch Site 006	Houston	Texas
United States	Bausch Site 020	Kansas City	Missouri
United States	Bausch Site 021	Mason	Ohio
United States	Bausch 018	Nashville	Tennessee
United States	Bausch Site 005	New York	New York
United States	Bausch Site 011	Newport Beach	California
United States	Bausch Site 012	Northridge	California
United States	Bausch Site 001	Phoenix	Arizona
United States	Bausch Site 013	Rancho Cordova	California
United States	Bausch Site 003	Reading	Pennsylvania
United States	Bausch Site 002	Saint Louis	Missouri
United States	Bausch 022	San Antonio	Texas
United States	Bausch Site 016	San Antonio	Texas
United States	Bausch Site 004	Torrance	California
United States	Bausch Site 015	Washington	Missouri

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	Percentage of Participants Who Experienced at Least One Intraocular Pressure (IOP) Measurement =30 Millimeters of Mercury (mmHg) at Any Post-Surgical Follow-up Visit		Up to 90 Days ± 14 Days
Primary	Change From Baseline in Corneal Endothelial Cell Density (ECD) in the Study Eye at Postoperative Visit 5 (90 Days ± 14 Days)		Baseline, 90 Days ± 14 Days
Secondary	Mean Change From Baseline in IOP at the 6-Hour Post-Operative Visit		Baseline, 6-hour post-operative
Secondary	Mean Change From Baseline in IOP at the 24-Hour Post-Operative Visit		Baseline, 24-hour post-operative
Secondary	Percentage of Participants With Summed Score for Anterior Chamber Cells and Flare Greater Than Zero at the 6-Hour and 24-Hour Post-Operative Visits	Anterior chamber cells were graded on a 6-point scale, with 0 = <1 cell count; 0.5 = 1 to 5 cell count; 1 = 6 to 15 cell count; 2 = 16 to 25 cell count; 3 = 26 to 50 cell count; and 4 = >50 cell count. Anterior chamber flare (protein escaping from dilated vessels) was graded on a 5-point scale, with 0 = none; 1 = faint; 2 = moderate; 3 = marked; and 4 = intense.	6-hour and 24-hour post-operative