Cataract
Conditions
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.
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.
Interventions
DEVICECVisc50 OVD
Bausch + Lomb CVisc50 Cohesive OVD
DEVICEProVisc OVD
ProVisc OVD
PROCEDURECataract Surgery
Cataract Surgery
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in IOP at the 6-Hour Post-Operative Visit | Baseline, 6-hour post-operative | — |
| Mean Change From Baseline in IOP at the 24-Hour Post-Operative Visit | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 192 |
| 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 | 196 |
| Total | 388 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Discontinued after surgery | 5 | 3 |
| Overall Study | Discontinued before surgery | 2 | 0 |
Baseline characteristics
| Characteristic | CVisc50 Ophthalmic Viscosurgical Device (OVD) | ProVisc OVD | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 133 Participants | 131 Participants | 264 Participants |
| Age, Categorical Between 18 and 65 years | 59 Participants | 65 Participants | 124 Participants |
| Age, Continuous | 68.7 Years STANDARD_DEVIATION 7.78 | 67.9 Years STANDARD_DEVIATION 8.24 | 68.3 Years STANDARD_DEVIATION 8.01 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 33 Participants | 21 Participants | 54 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 159 Participants | 175 Participants | 334 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 26 Participants | 26 Participants | 52 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 19 Participants | 30 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 154 Participants | 149 Participants | 303 Participants |
| Region of Enrollment United States | 192 participants | 196 participants | 388 participants |
| Sex: Female, Male Female | 115 Participants | 127 Participants | 242 Participants |
| Sex: Female, Male Male | 77 Participants | 69 Participants | 146 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 192 | 0 / 196 |
| other Total, other adverse events | 62 / 192 | 63 / 196 |
| serious Total, serious adverse events | 0 / 192 | 0 / 196 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CVisc50 Ophthalmic Viscosurgical Device (OVD) | 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 2.8 |
| ProVisc OVD | Change From Baseline in Corneal Endothelial Cell Density (ECD) in the Study Eye at Postoperative Visit 5 (90 Days ± 14 Days) | 15.8 cells/mm2 | Standard Deviation 3.04 |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CVisc50 Ophthalmic Viscosurgical Device (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 Participants |
| 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 | 16 Participants |
Secondary
Mean Change From Baseline in IOP at the 24-Hour Post-Operative Visit
Time frame: Baseline, 24-hour post-operative
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CVisc50 Ophthalmic Viscosurgical Device (OVD) | Mean Change From Baseline in IOP at the 24-Hour Post-Operative Visit | Observed Value at baseline | 18.0 mmhg | Standard Deviation 4.7 |
| CVisc50 Ophthalmic Viscosurgical Device (OVD) | Mean Change From Baseline in IOP at the 24-Hour Post-Operative Visit | Change from Baseline | 2.3 mmhg | Standard Deviation 4.57 |
| ProVisc OVD | Mean Change From Baseline in IOP at the 24-Hour Post-Operative Visit | Observed Value at baseline | 18.4 mmhg | Standard Deviation 4.78 |
| ProVisc OVD | Mean Change From Baseline in IOP at the 24-Hour Post-Operative Visit | Change from Baseline | 2.6 mmhg | Standard Deviation 4.73 |
Secondary
Mean Change From Baseline in IOP at the 6-Hour Post-Operative Visit
Time frame: Baseline, 6-hour post-operative
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CVisc50 Ophthalmic Viscosurgical Device (OVD) | Mean Change From Baseline in IOP at the 6-Hour Post-Operative Visit | Observed value at baseline. | 19.5 mmhg | Standard Deviation 6.53 |
| CVisc50 Ophthalmic Viscosurgical Device (OVD) | Mean Change From Baseline in IOP at the 6-Hour Post-Operative Visit | Change from baseline. | 3.8 mmhg | Standard Deviation 6.29 |
| ProVisc OVD | Mean Change From Baseline in IOP at the 6-Hour Post-Operative Visit | Observed value at baseline. | 20.0 mmhg | Standard Deviation 6.75 |
| ProVisc OVD | Mean Change From Baseline in IOP at the 6-Hour Post-Operative Visit | Change from baseline. | 4.2 mmhg | Standard Deviation 6.87 |
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CVisc50 Ophthalmic Viscosurgical Device (OVD) | 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 |
| CVisc50 Ophthalmic Viscosurgical Device (OVD) | 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 |
| ProVisc OVD | 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 | 187 Participants |
| ProVisc OVD | 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 | 184 Participants |