Bausch & Lomb Ophthalmic Viscosurgical Device (OVD) Dispersive (DVisc40)
Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT03511638
Collaborator
(none)
372
1
2
10.7
34.6
Study Details
Study Description
Brief Summary
A Study to Document the Safety and Effectiveness of a New OVD When Compared to a Control OVD
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This is a multicenter, controlled, randomized, monocular trial evaluating the safety and effectiveness of the Bausch & Lomb DVisc40 dispersive OVD compared to the Alcon VISCOAT® dispersive OVD when used in cataract surgery. Subjects will be randomized to one of the two treatment groups in a 1:1 ratio (DVisc40:VISCOAT®).
Study Design
Study Type:
Interventional
Actual Enrollment
:
372 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
a multicenter, controlled, randomized, monocular trial of Bausch & Lomb DVisc40 (test) OVD compared to the currently marketed Alcon VISCOAT® (control) OVDa multicenter, controlled, randomized, monocular trial of Bausch & Lomb DVisc40 (test) OVD compared to the currently marketed Alcon VISCOAT® (control) OVD
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Study to Document the Safety and Effectiveness of a New OVD When Compared to a Control OVD
Actual Study Start Date
:
May 9, 2018
Actual Primary Completion Date
:
Apr 1, 2019
Actual Study Completion Date
:
Apr 1, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Bausch & Lomb DVisc40 Ophthalmic viscosurgical device |
Device: Bausch & Lomb DVisc40
Ophthalmic viscosurgical device
|
| Active Comparator: Alcon VISCOAT® Ophthalmic viscosurgical device |
Device: Alcon VISCOAT®
Ophthalmic viscosurgical device
|
Outcome Measures
Primary Outcome Measures
- Percent Change in Mean Epithelial Cell Density (ECD) [Day 90]
- Percentage of Participants With Postoperative Intraocular Pressure of at Least 30 mm Hg [90 days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
45 Years
to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- The subject 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 subject 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 subject must be willing and able to return for all scheduled follow-up examinations through 90 days following surgery.
Study #877 Protocol DVisc40 28JUL2017 V1.0 CONFIDENTIAL Page 16 of 53 4. The subject must have clear intraocular media other than the cataract in the operative eye.
Exclusion Criteria:
-
- The subject has participated in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation.
-
The subject has any corneal pathology (e.g., significant scarring, guttata, inflammation, edema, dystrophy, etc.) in the operative eye.
-
The subject has anterior segment pathology likely to increase the risk of an adverse outcome for phacoemulsification cataract surgery (e.g., pseudoexfoliation syndrome, synechiae, iris atrophy, inadequate dilation, shallow anterior chamber, traumatic cataract, lens subluxation) in the operative eye.
-
The subject has any condition which prevents reliable specular microscopy in the operative eye.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Valeant Site 01 | San Diego | California | United States | 22434 |
Sponsors and Collaborators
- Bausch & Lomb Incorporated
Investigators
- Study Director: Anya Loncaric, Bausch Health Americas, Inc.
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT03511638
Other Study ID Numbers:
- S877
First Posted:
Apr 30, 2018
Last Update Posted:
Oct 22, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Bausch & Lomb DVisc40 | Alcon VISCOAT® |
|---|---|---|
| Arm/Group Description | Ophthalmic viscosurgical device Bausch & Lomb DVisc40: Ophthalmic viscosurgical device | Ophthalmic viscosurgical device Alcon VISCOAT®: Ophthalmic viscosurgical device |
| Period Title: Overall Study | ||
| STARTED | 184 | 188 |
| COMPLETED | 182 | 187 |
| NOT COMPLETED | 2 | 1 |
Baseline Characteristics
| Arm/Group Title | Bausch & Lomb DVisc40 | Alcon VISCOAT® | Total |
|---|---|---|---|
| Arm/Group Description | Ophthalmic viscosurgical device Bausch & Lomb DVisc40: Ophthalmic viscosurgical device | Ophthalmic viscosurgical device Alcon VISCOAT®: Ophthalmic viscosurgical device | Total of all reporting groups |
| Overall Participants | 184 | 188 | 372 |
| Age (years) [Median (Full Range) ] | |||
| Median (Full Range) [years] |
70.0
|
69.0
|
70.0
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
111
60.3%
|
120
63.8%
|
231
62.1%
|
| Male |
73
39.7%
|
68
36.2%
|
141
37.9%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
1
0.5%
|
0
0%
|
1
0.3%
|
| Asian |
39
21.2%
|
43
22.9%
|
82
22%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
19
10.3%
|
7
3.7%
|
26
7%
|
| White |
122
66.3%
|
136
72.3%
|
258
69.4%
|
| More than one race |
2
1.1%
|
2
1.1%
|
4
1.1%
|
| Unknown or Not Reported |
1
0.5%
|
0
0%
|
1
0.3%
|
| Study eye - right or left (Count of Participants) | |||
| Right Eye |
91
49.5%
|
110
58.5%
|
201
54%
|
| Left Eye |
93
50.5%
|
78
41.5%
|
171
46%
|
Outcome Measures
| Title | Percent Change in Mean Epithelial Cell Density (ECD) |
|---|---|
| Description | |
| Time Frame | Day 90 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with epithelial cell density at baseline and Day 90 were included in the analysis. |
| Arm/Group Title | Bausch & Lomb DVisc40 | Alcon VISCOAT® |
|---|---|---|
| Arm/Group Description | Ophthalmic viscosurgical device Bausch & Lomb DVisc40: Ophthalmic viscosurgical device | Ophthalmic viscosurgical device Alcon VISCOAT®: Ophthalmic viscosurgical device |
| Measure Participants | 168 | 178 |
| Mean (Standard Deviation) [percentage change in ECD] |
-8.4
(12.19)
|
-6.8
(12.54)
|
| Title | Percentage of Participants With Postoperative Intraocular Pressure of at Least 30 mm Hg |
|---|---|
| Description | |
| Time Frame | 90 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Bausch & Lomb DVisc40 | Alcon VISCOAT® |
|---|---|---|
| Arm/Group Description | Ophthalmic viscosurgical device Bausch & Lomb DVisc40: Ophthalmic viscosurgical device | Ophthalmic viscosurgical device Alcon VISCOAT®: Ophthalmic viscosurgical device |
| Measure Participants | 184 | 188 |
| Number [percentage of participants] |
17.4
9.5%
|
20.3
10.8%
|
Adverse Events
| Time Frame | 90 days | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Bausch & Lomb DVisc40 | Alcon VISCOAT® | ||
| Arm/Group Description | Ophthalmic viscosurgical device Bausch & Lomb DVisc40: Ophthalmic viscosurgical device | Ophthalmic viscosurgical device Alcon VISCOAT®: Ophthalmic viscosurgical device | ||
All Cause Mortality |
||||
| Bausch & Lomb DVisc40 | Alcon VISCOAT® | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/184 (0%) | 0/188 (0%) | ||
Serious Adverse Events |
||||
| Bausch & Lomb DVisc40 | Alcon VISCOAT® | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/184 (0.5%) | 4/188 (2.1%) | ||
| Eye disorders | ||||
| Posterior capsule rupture | 0/184 (0%) | 2/188 (1.1%) | ||
| Injury, poisoning and procedural complications | ||||
| Cataract operation complication | 0/184 (0%) | 1/188 (0.5%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Acute respiratory failure | 1/184 (0.5%) | 0/188 (0%) | ||
| Chronic obstructive pulmonary disorder | 1/184 (0.5%) | 0/188 (0%) | ||
| Vascular disorders | ||||
| Aortic aneurysm | 0/184 (0%) | 1/188 (0.5%) | ||
| Hypertension | 0/184 (0%) | 1/188 (0.5%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Bausch & Lomb DVisc40 | Alcon VISCOAT® | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 48/184 (26.1%) | 51/188 (27.1%) | ||
| Eye disorders | ||||
| Punctate keratitis | 17/184 (9.2%) | 13/188 (6.9%) | ||
| Investigations | ||||
| Intraocular pressure increased | 31/184 (16.8%) | 38/188 (20.2%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Please contact sponsor directly for details.
Results Point of Contact
| Name/Title | Study Director |
|---|---|
| Organization | Bausch & Lomb |
| Phone | 510-259-5284 |
| aloncaric@bauschhealth.com |
Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT03511638
Other Study ID Numbers:
- S877
First Posted:
Apr 30, 2018
Last Update Posted:
Oct 22, 2021
Last Verified:
Sep 1, 2021