Cataract
Conditions
Brief summary
A Study to Document the Safety and Effectiveness of a New OVD When Compared to a Control OVD
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®).
Interventions
DEVICEBausch & Lomb DVisc40
Ophthalmic viscosurgical device
DEVICEAlcon VISCOAT®
Ophthalmic viscosurgical device
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
a multicenter, controlled, randomized, monocular trial of Bausch & Lomb DVisc40 (test) OVD compared to the currently marketed Alcon VISCOAT® (control) OVD
Eligibility
Sex/Gender
ALL
Age
45 Years to 99 Years
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. 2\. 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. 3\. 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
* 1\. 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. 2\. The subject has any corneal pathology (e.g., significant scarring, guttata, inflammation, edema, dystrophy, etc.) in the operative eye. 3\. 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. 4\. The subject has any condition which prevents reliable specular microscopy in the operative eye.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bausch & Lomb DVisc40 Ophthalmic viscosurgical device
Bausch & Lomb DVisc40: Ophthalmic viscosurgical device | 184 |
| Alcon VISCOAT® Ophthalmic viscosurgical device
Alcon VISCOAT®: Ophthalmic viscosurgical device | 188 |
| Total | 372 |
Baseline characteristics
| Characteristic | Bausch & Lomb DVisc40 | Alcon VISCOAT® | Total |
|---|---|---|---|
| Age, Continuous | 70.0 years | 69.0 years | 70.0 years |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 39 Participants | 43 Participants | 82 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 7 Participants | 26 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 122 Participants | 136 Participants | 258 Participants |
| Sex: Female, Male Female | 111 Participants | 120 Participants | 231 Participants |
| Sex: Female, Male Male | 73 Participants | 68 Participants | 141 Participants |
| Study eye - right or left Left Eye | 93 Participants | 78 Participants | 171 Participants |
| Study eye - right or left Right Eye | 91 Participants | 110 Participants | 201 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 184 | 0 / 188 |
| other Total, other adverse events | 48 / 184 | 51 / 188 |
| serious Total, serious adverse events | 1 / 184 | 4 / 188 |
Outcome results
Primary
Percentage of Participants With Postoperative Intraocular Pressure of at Least 30 mm Hg
Time frame: 90 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bausch & Lomb DVisc40 | Percentage of Participants With Postoperative Intraocular Pressure of at Least 30 mm Hg | 17.4 percentage of participants |
| Alcon VISCOAT® | Percentage of Participants With Postoperative Intraocular Pressure of at Least 30 mm Hg | 20.3 percentage of participants |
Primary
Percent Change in Mean Epithelial Cell Density (ECD)
Time frame: Day 90
Population: Participants with epithelial cell density at baseline and Day 90 were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bausch & Lomb DVisc40 | Percent Change in Mean Epithelial Cell Density (ECD) | -8.4 percentage change in ECD | Standard Deviation 12.19 |
| Alcon VISCOAT® | Percent Change in Mean Epithelial Cell Density (ECD) | -6.8 percentage change in ECD | Standard Deviation 12.54 |