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

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04192630
• Collaborator: (none)
• Enrollment: 390
• Locations: 22
• Arms: 2
• Actual Duration (Months): 26.2
• Patients Per Site: 17.7
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: CVisc50 OVD; Device: ProVisc OVD	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 390 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Study to Document the Safety and Effectiveness of a New Cohesive OVD When Compared to a Control OVD
• Actual Study Start Date: Nov 26, 2019
• Actual Primary Completion Date: Jan 31, 2022
• Actual Study Completion Date: Jan 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CVisc50 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 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; CVisc50 OVD sterile solution will be injected into the anterior chamber per the schedule specified in the arm.; Other Names: Bausch + Lomb CVisc50 Cohesive OVD
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.	Device: ProVisc OVD; ProVisc OVD sterile solution will be injected into the anterior chamber per the schedule specified in the arm.; Other Names: Alcon ProVisc® OVD

Outcome Measures

Primary Outcome Measures

1. 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]

2. 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 Outcome Measures

1. Mean Change From Baseline in IOP at the 6-Hour Post-Operative Visit [Baseline, 6-hour post-operative]

2. Mean Change From Baseline in IOP at the 24-Hour Post-Operative Visit [Baseline, 24-hour post-operative]

3. 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 [6-hour and 24-hour post-operative]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bausch Site 017	Chandler	Arizona	United States	85224
2	Bausch Site 001	Phoenix	Arizona	United States	85032
3	Bausch Site 008	Fayetteville	Arkansas	United States	72704
4	Bausch Site 010	Burlingame	California	United States	94010
5	Bausch Site 007	Garden Grove	California	United States	92843
6	Bausch Site 011	Newport Beach	California	United States	92662
7	Bausch Site 012	Northridge	California	United States	91325
8	Bausch Site 013	Rancho Cordova	California	United States	95670
9	Bausch Site 004	Torrance	California	United States	90505
10	Bausch Site 019	Bloomington	Minnesota	United States	55420
11	Bausch Site 020	Kansas City	Missouri	United States	64154
12	Bausch Site 002	Saint Louis	Missouri	United States	63131
13	Bausch Site 015	Washington	Missouri	United States	63090
14	Bausch Site 005	New York	New York	United States	10013
15	Bausch Site 021	Mason	Ohio	United States	45040
16	Bausch Site 003	Reading	Pennsylvania	United States	96002
17	Bausch Site 014	Goodlettsville	Tennessee	United States	37073
18	Bausch 018	Nashville	Tennessee	United States	37215
19	Bausch Site 009	Cedar Park	Texas	United States	78613
20	Bausch Site 006	Houston	Texas	United States	77008
21	Bausch 022	San Antonio	Texas	United States	78215
22	Bausch Site 016	San Antonio	Texas	United States	78229

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

• Study Director: Anya Loncaric, B+L

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT04192630
• Other Study ID Numbers: 878
• First Posted: Dec 10, 2019
• Last Update Posted: Jul 8, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Cataract; Hyaluronic Acid

Study Results

No Results Posted as of Jul 8, 2022