Trial Outcomes & Findings for A Study of B + L Ophthalmic Viscosurgical Device (OVD) CVisc50 (NCT NCT04192630)
NCT ID: NCT04192630
Last Updated: 2024-05-28
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
390 participants
Primary outcome timeframe
Up to 90 Days ± 14 Days
Results posted on
2024-05-28
Participant Flow
Participant milestones
| Measure |
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.
CVisc50 OVD: Bausch + Lomb CVisc50 Cohesive OVD
Cataract Surgery: Cataract Surgery
|
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.
ProVisc OVD: ProVisc OVD
Cataract Surgery: Cataract Surgery
|
|---|---|---|
|
Overall Study
STARTED
|
194
|
196
|
|
Overall Study
COMPLETED
|
187
|
193
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
Reasons for withdrawal
| Measure |
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.
CVisc50 OVD: Bausch + Lomb CVisc50 Cohesive OVD
Cataract Surgery: Cataract Surgery
|
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.
ProVisc OVD: ProVisc OVD
Cataract Surgery: Cataract Surgery
|
|---|---|---|
|
Overall Study
Discontinued before surgery
|
2
|
0
|
|
Overall Study
Discontinued after surgery
|
5
|
3
|
Baseline Characteristics
A Study of B + L Ophthalmic Viscosurgical Device (OVD) CVisc50
Baseline characteristics by cohort
| Measure |
CVisc50 Ophthalmic Viscosurgical Device (OVD)
n=192 Participants
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.
CVisc50 OVD: Bausch + Lomb CVisc50 Cohesive OVD
Cataract Surgery: Cataract Surgery
|
ProVisc OVD
n=196 Participants
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.
ProVisc OVD: ProVisc OVD
Cataract Surgery: Cataract Surgery
|
Total
n=388 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
59 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
133 Participants
n=5 Participants
|
131 Participants
n=7 Participants
|
264 Participants
n=5 Participants
|
|
Age, Continuous
|
68.7 Years
STANDARD_DEVIATION 7.78 • n=5 Participants
|
67.9 Years
STANDARD_DEVIATION 8.24 • n=7 Participants
|
68.3 Years
STANDARD_DEVIATION 8.01 • n=5 Participants
|
|
Sex: Female, Male
Female
|
115 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
242 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
33 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
159 Participants
n=5 Participants
|
175 Participants
n=7 Participants
|
334 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
154 Participants
n=5 Participants
|
149 Participants
n=7 Participants
|
303 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
192 participants
n=5 Participants
|
196 participants
n=7 Participants
|
388 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 90 Days ± 14 DaysOutcome measures
| Measure |
CVisc50 Ophthalmic Viscosurgical Device (OVD)
n=192 Participants
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.
CVisc50 OVD: Bausch + Lomb CVisc50 Cohesive OVD
Cataract Surgery: Cataract Surgery
|
ProVisc OVD
n=196 Participants
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.
ProVisc OVD: ProVisc OVD
Cataract Surgery: Cataract Surgery
|
|---|---|---|
|
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 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: Baseline, 90 Days ± 14 DaysOutcome measures
| Measure |
CVisc50 Ophthalmic Viscosurgical Device (OVD)
n=191 Participants
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.
CVisc50 OVD: Bausch + Lomb CVisc50 Cohesive OVD
Cataract Surgery: Cataract Surgery
|
ProVisc OVD
n=195 Participants
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.
ProVisc OVD: ProVisc OVD
Cataract Surgery: Cataract Surgery
|
|---|---|---|
|
Change From Baseline in Corneal Endothelial Cell Density (ECD) in the Study Eye at Postoperative Visit 5 (90 Days ± 14 Days)
|
15.7 cells/mm2
Standard Deviation 2.80
|
15.8 cells/mm2
Standard Deviation 3.04
|
SECONDARY outcome
Timeframe: Baseline, 6-hour post-operativeOutcome measures
| Measure |
CVisc50 Ophthalmic Viscosurgical Device (OVD)
n=191 Participants
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.
CVisc50 OVD: Bausch + Lomb CVisc50 Cohesive OVD
Cataract Surgery: Cataract Surgery
|
ProVisc OVD
n=196 Participants
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.
ProVisc OVD: ProVisc OVD
Cataract Surgery: Cataract Surgery
|
|---|---|---|
|
Mean Change From Baseline in IOP at the 6-Hour Post-Operative Visit
Observed value at baseline.
|
19.5 mmhg
Standard Deviation 6.53
|
20.0 mmhg
Standard Deviation 6.75
|
|
Mean Change From Baseline in IOP at the 6-Hour Post-Operative Visit
Change from baseline.
|
3.8 mmhg
Standard Deviation 6.29
|
4.2 mmhg
Standard Deviation 6.87
|
SECONDARY outcome
Timeframe: Baseline, 24-hour post-operativeOutcome measures
| Measure |
CVisc50 Ophthalmic Viscosurgical Device (OVD)
n=192 Participants
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.
CVisc50 OVD: Bausch + Lomb CVisc50 Cohesive OVD
Cataract Surgery: Cataract Surgery
|
ProVisc OVD
n=195 Participants
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.
ProVisc OVD: ProVisc OVD
Cataract Surgery: Cataract Surgery
|
|---|---|---|
|
Mean Change From Baseline in IOP at the 24-Hour Post-Operative Visit
Observed Value at baseline
|
18.0 mmhg
Standard Deviation 4.70
|
18.4 mmhg
Standard Deviation 4.78
|
|
Mean Change From Baseline in IOP at the 24-Hour Post-Operative Visit
Change from Baseline
|
2.3 mmhg
Standard Deviation 4.57
|
2.6 mmhg
Standard Deviation 4.73
|
SECONDARY outcome
Timeframe: 6-hour and 24-hour post-operativeAnterior 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.
Outcome measures
| Measure |
CVisc50 Ophthalmic Viscosurgical Device (OVD)
n=191 Participants
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.
CVisc50 OVD: Bausch + Lomb CVisc50 Cohesive OVD
Cataract Surgery: Cataract Surgery
|
ProVisc OVD
n=195 Participants
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.
ProVisc OVD: ProVisc OVD
Cataract Surgery: Cataract Surgery
|
|---|---|---|
|
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 Post-Operative Visits
|
177 Participants
|
187 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
24-Hour Post-Operative Visits
|
183 Participants
|
184 Participants
|
Adverse Events
CVisc50 Ophthalmic Viscosurgical Device (OVD)
Serious events: 0 serious events
Other events: 62 other events
Deaths: 0 deaths
ProVisc OVD
Serious events: 0 serious events
Other events: 63 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CVisc50 Ophthalmic Viscosurgical Device (OVD)
n=192 participants at risk
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.
CVisc50 OVD: Bausch + Lomb CVisc50 Cohesive OVD
Cataract Surgery: Cataract Surgery
|
ProVisc OVD
n=196 participants at risk
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.
ProVisc OVD: ProVisc OVD
Cataract Surgery: Cataract Surgery
|
|---|---|---|
|
General disorders
Treatment-Emergent Adverse Events
|
32.3%
62/192 • Number of events 75 • Up to 164 days from preoperative visit to post operative visit 5
Ocular Adverse Event
|
32.1%
63/196 • Number of events 90 • Up to 164 days from preoperative visit to post operative visit 5
Ocular Adverse Event
|
Additional Information
Anya Loncaric, Executive Director, Global Clinical Operations
Bausch + Lomb Incorporated
Phone: (310) 770-7750
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place