CompletedNCT04192630Updated May 28, 2024Results posted

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

An interventional study of CVisc50 OVD and ProVisc OVD in Cataract, sponsored by Bausch & Lomb Incorporated. Completed at 22 sites in United States. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2024-05-28.

Sponsored by Bausch & Lomb Incorporated · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 390
Allocation: Randomized
Ages: 45 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Cataract

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Cataract 1,701

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 390 is above the median of 80 across 1,155 interventional studies indexed under Cataract.

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Lead sponsor

Bausch & Lomb Incorporated is the lead sponsor of 219 studies on the registry; 7 are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 41 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 45 Years and older
Sexes eligible: 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

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 design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Outcomes assessor)
Enrollment: 390 participants (actual)

Study arms

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 · Procedure: 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.
Device: ProVisc OVD · Procedure: Cataract Surgery

Interventions

DeviceCVisc50 OVD
Bausch + Lomb CVisc50 Cohesive OVD
Also known as: Bausch + Lomb CVisc50 Cohesive OVD
DeviceProVisc OVD
ProVisc OVD
Also known as: Alcon ProVisc® OVD
ProcedureCataract Surgery
Cataract Surgery

What researchers measure

Primary outcomes

Percentage of Participants Who Experienced at Least One Intraocular Pressure (IOP) Measurement ≥30 Millimeters of Mercury (mmHg) at Any Post-Surgical Follow-up Visit
Time frame: Up to 90 Days ± 14 Days
Change From Baseline in Corneal Endothelial Cell Density (ECD) in the Study Eye at Postoperative Visit 5 (90 Days ± 14 Days)
Time frame: Baseline, 90 Days ± 14 Days

Secondary outcomes

Mean Change From Baseline in IOP at the 6-Hour Post-Operative Visit
Time frame: Baseline, 6-hour post-operative
Mean Change From Baseline in IOP at the 24-Hour Post-Operative Visit
Time frame: 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.
Time frame: 6-hour and 24-hour post-operative

Results

Posted May 28, 2024

Participant flow

Participant flow — Overall Study
Milestone	CVisc50 Ophthalmic Viscosurgical Device (OVD)	ProVisc OVD
Started	194	196
Completed	187	193
Not completed	7	3
Withdrew: Discontinued before surgery	2	0
Withdrew: Discontinued after surgery	5	3

Outcome measures

PrimaryPercentage of Participants Who Experienced at Least One Intraocular Pressure (IOP) Measurement ≥30 Millimeters of Mercury (mmHg) at Any Post-Surgical Follow-up Visit

Time frame:: Up to 90 Days ± 14 Days
Reported as:: Count of participants · Participants

Percentage of Participants Who Experienced at Least One Intraocular Pressure (IOP) Measurement ≥30 Millimeters of Mercury (mmHg) at Any Post-Surgical Follow-up Visit
Participants	CVisc50 Ophthalmic Viscosurgical Device (OVD)	ProVisc OVD
Percentage of Participants Who Experienced at Least One Intraocular Pressure (IOP) Measurement ≥30 Millimeters of Mercury (mmHg) at Any Post-Surgical Follow-up Visit	10	16

PrimaryChange From Baseline in Corneal Endothelial Cell Density (ECD) in the Study Eye at Postoperative Visit 5 (90 Days ± 14 Days)

Time frame:: Baseline, 90 Days ± 14 Days
Reported as:: Mean · cells/mm2

Change From Baseline in Corneal Endothelial Cell Density (ECD) in the Study Eye at Postoperative Visit 5 (90 Days ± 14 Days)
cells/mm2	CVisc50 Ophthalmic Viscosurgical Device (OVD)	ProVisc OVD
Change From Baseline in Corneal Endothelial Cell Density (ECD) in the Study Eye at Postoperative Visit 5 (90 Days ± 14 Days)	15.7 ± 2.80	15.8 ± 3.04

SecondaryMean Change From Baseline in IOP at the 6-Hour Post-Operative Visit

Time frame:: Baseline, 6-hour post-operative
Reported as:: Mean · mmhg

Mean Change From Baseline in IOP at the 6-Hour Post-Operative Visit
mmhg	CVisc50 Ophthalmic Viscosurgical Device (OVD)	ProVisc OVD
Observed value at baseline.	19.5 ± 6.53	20.0 ± 6.75
Change from baseline.	3.8 ± 6.29	4.2 ± 6.87

SecondaryMean Change From Baseline in IOP at the 24-Hour Post-Operative Visit

Time frame:: Baseline, 24-hour post-operative
Reported as:: Mean · mmhg

Mean Change From Baseline in IOP at the 24-Hour Post-Operative Visit
mmhg	CVisc50 Ophthalmic Viscosurgical Device (OVD)	ProVisc OVD
Observed Value at baseline	18.0 ± 4.70	18.4 ± 4.78
Change from Baseline	2.3 ± 4.57	2.6 ± 4.73

SecondaryPercentage 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.

Time frame:: 6-hour and 24-hour post-operative
Reported as:: Count of participants · Participants

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
Participants	CVisc50 Ophthalmic Viscosurgical Device (OVD)	ProVisc OVD
6-Hour Post-Operative Visits	177	187
24-Hour Post-Operative Visits	183	184

Adverse events

Collected over Up to 164 days from preoperative visit to post operative visit 5. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
CVisc50 Ophthalmic Viscosurgical Device (OVD)	0/192 (0%)	0/192 (0%)	62/192 (32.3%)
ProVisc OVD	0/196 (0%)	0/196 (0%)	63/196 (32.1%)

Most frequent other events

Most frequent other events
Event	CVisc50 Ophthalmic Viscosurgical Device (OVD)	ProVisc OVD
Treatment-Emergent Adverse EventsGeneral disorders	62/192	63/196

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	CVisc50 Ophthalmic Viscosurgical Device (OVD)	ProVisc OVD	Total
<=18 years	0	0	0
Between 18 and 65 years	59	65	124
>=65 years	133	131	264

Age, Continuous
Age, Continuous(Years)	CVisc50 Ophthalmic Viscosurgical Device (OVD)	ProVisc OVD	Total
Mean	68.7 ± 7.78	67.9 ± 8.24	68.3 ± 8.01

Sex: Female, Male
Sex: Female, Male(Participants)	CVisc50 Ophthalmic Viscosurgical Device (OVD)	ProVisc OVD	Total
Female	115	127	242
Male	77	69	146

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	CVisc50 Ophthalmic Viscosurgical Device (OVD)	ProVisc OVD	Total
Hispanic or Latino	33	21	54
Not Hispanic or Latino	159	175	334
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	CVisc50 Ophthalmic Viscosurgical Device (OVD)	ProVisc OVD	Total
American Indian or Alaska Native	0	0	0
Asian	26	26	52
Native Hawaiian or Other Pacific Islander	1	2	3
Black or African American	11	19	30
White	154	149	303
More than one race	0	0	0
Unknown or Not Reported	0	0	0

Region of Enrollment
Region of Enrollment(participants)	CVisc50 Ophthalmic Viscosurgical Device (OVD)	ProVisc OVD	Total
United States	192	196	388

Study locations

22 sites

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

References and documents

Study documents

Protocol and statistical analysis plan · Aug 9, 2021

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04192630
Lead sponsor: Bausch & Lomb Incorporated
Responsible party: Sponsor
First posted: Dec 10, 2019
Start date: Nov 26, 2019
Primary completion: Jan 31, 2022
Completion: Jan 31, 2022
Results posted: May 28, 2024
Last update: May 28, 2024

Study contacts

Anya Loncaric

study director · B+L

Oversight

FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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