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

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

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: CVisc50 OVD; Procedure: Cataract Surgery; Device: ProVisc OVD

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 390
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Bausch Site 017
    • Phoenix, Arizona, United States, 85032
      • Bausch Site 001
  • Arkansas
    • Fayetteville, Arkansas, United States, 72704
      • Bausch Site 008
  • California
    • Burlingame, California, United States, 94010
      • Bausch Site 010
    • Garden Grove, California, United States, 92843
      • Bausch Site 007
    • Newport Beach, California, United States, 92662
      • Bausch Site 011
    • Northridge, California, United States, 91325
      • Bausch Site 012
    • Rancho Cordova, California, United States, 95670
      • Bausch Site 013
    • Torrance, California, United States, 90505
      • Bausch Site 004
  • Minnesota
    • Bloomington, Minnesota, United States, 55420
      • Bausch Site 019
  • Missouri
    • Kansas City, Missouri, United States, 64154
      • Bausch Site 020
    • Saint Louis, Missouri, United States, 63131
      • Bausch Site 002
    • Washington, Missouri, United States, 63090
      • Bausch Site 015
  • New York
    • New York, New York, United States, 10013
      • Bausch Site 005
  • Ohio
    • Mason, Ohio, United States, 45040
      • Bausch Site 021
  • Pennsylvania
    • Reading, Pennsylvania, United States, 96002
      • Bausch Site 003
  • Tennessee
    • Goodlettsville, Tennessee, United States, 37073
      • Bausch Site 014
    • Nashville, Tennessee, United States, 37215
      • Bausch 018
  • Texas
    • Cedar Park, Texas, United States, 78613
      • Bausch Site 009
    • Houston, Texas, United States, 77008
      • Bausch Site 006
    • San Antonio, Texas, United States, 78215
      • Bausch 022
    • San Antonio, Texas, United States, 78229
      • Bausch Site 016

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CVisc50 Ophthalmic Viscosurgical Device (OVD); CVisc50 OVD will be carefully injected into the anterior chamber using standard aseptic technique, during the surgical procedure. The duration of the treatment is anticipated to be approximately 15-20 minutes for the surgical procedure. The OVD may also be used to coat surgical instruments prior to Intraocular Lens (IOL) implantation (for example, the internal surfaces of an IOL inserter are typically filled and/or coated with the OVD to provide lubricity during IOL compression and delivery into the eye). Additional OVD of the same product, may be injected as needed throughout surgery to keep the anterior chamber fully formed and to re-inflate the capsular bag following cataract removal. At the end of the surgical procedure it is recommended that OVD be removed from the eye as completely as practical by thoroughly irrigating and aspirating with a sterile irrigating solution.	Device: CVisc50 OVD; Bausch + Lomb CVisc50 Cohesive OVD; Other Names: Bausch + Lomb CVisc50 Cohesive OVD; Procedure: Cataract Surgery; Cataract Surgery
Active Comparator: ProVisc OVD; ProVisc OVD will be carefully injected into the anterior chamber using standard aseptic technique, during the surgical procedure. The duration of the treatment is anticipated to be approximately 15-20 minutes for the surgical procedure. The OVD may also be used to coat surgical instruments prior to IOL implantation (for example, the internal surfaces of an IOL inserter are typically filled and/or coated with the OVD to provide lubricity during IOL compression and delivery into the eye). Additional OVD of the same product, may be injected as needed throughout surgery to keep the anterior chamber fully formed and to re-inflate the capsular bag following cataract removal. At the end of the surgical procedure it is recommended that OVD be removed from the eye as completely as practical by thoroughly irrigating and aspirating with a sterile irrigating solution.	Procedure: Cataract Surgery; Cataract Surgery; Device: ProVisc OVD; ProVisc OVD; Other Names: Alcon ProVisc® OVD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in IOP at the 6-Hour Post-Operative Visit		Baseline, 6-hour post-operative
Mean Change From Baseline in IOP at the 24-Hour Post-Operative Visit		Baseline, 24-hour post-operative
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

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Study Director: Anya Loncaric, B+L

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2019
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: December 6, 2019
• First Submitted That Met QC Criteria: December 6, 2019
• First Posted (Actual): December 10, 2019

Study Record Updates

• Last Update Posted (Actual): May 28, 2024
• Last Update Submitted That Met QC Criteria: May 23, 2024
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: 878

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes