Clinical trial NCT04192630: A Study of B + L Ophthalmic Viscosurgical Device (OVD) CVisc50
Official title: A Study to Document the Safety and Effectiveness of a New Cohesive OVD When Compared to a Control OVD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2019-12-10
Enrollment: 390
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Who Experienced at Least One Intraocular Pressure (IOP) Measurement ≥30 Millimeters of Mercury (mmHg) at Any Post-Surgical Follow-up Visit
timeFrame: Up to 90 Days ± 14 Days
measure: Change From Baseline in Corneal Endothelial Cell Density (ECD) in the Study Eye at Postoperative Visit 5 (90 Days ± 14 Days)
timeFrame: Baseline, 90 Days ± 14 Days
Secondary outcomes:
measure: Mean Change From Baseline in IOP at the 6-Hour Post-Operative Visit
timeFrame: Baseline, 6-hour post-operative
measure: Mean Change From Baseline in IOP at the 24-Hour Post-Operative Visit
timeFrame: Baseline, 24-hour post-operative
measure: 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
timeFrame: 6-hour and 24-hour post-operative
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Bausch Site 017
state: Arizona
city: Phoenix
country: United States
facility: Bausch Site 001
state: Arizona
city: Fayetteville
country: United States
facility: Bausch Site 008
state: Arkansas
city: Burlingame
country: United States
facility: Bausch Site 010
state: California
city: Garden Grove
country: United States
facility: Bausch Site 007
state: California
city: Newport Beach
country: United States
facility: Bausch Site 011
state: California
city: Northridge
country: United States
facility: Bausch Site 012
state: California
city: Rancho Cordova
country: United States
facility: Bausch Site 013
state: California
city: Torrance
country: United States
facility: Bausch Site 004
state: California
city: Bloomington
country: United States
facility: Bausch Site 019
state: Minnesota
city: Kansas City
country: United States
facility: Bausch Site 020
state: Missouri
city: Saint Louis
country: United States
facility: Bausch Site 002
state: Missouri
city: Washington
country: United States
facility: Bausch Site 015
state: Missouri
city: New York
country: United States
facility: Bausch Site 005
state: New York
city: Mason
country: United States
facility: Bausch Site 021
state: Ohio
city: Reading
country: United States
facility: Bausch Site 003
state: Pennsylvania
city: Goodlettsville
country: United States
facility: Bausch Site 014
state: Tennessee
city: Nashville
country: United States
facility: Bausch 018
state: Tennessee
city: Cedar Park
country: United States
facility: Bausch Site 009
state: Texas
city: Houston
country: United States
facility: Bausch Site 006
state: Texas
city: San Antonio
country: United States
facility: Bausch 022
state: Texas
city: San Antonio
country: United States
facility: Bausch Site 016
state: Texas
Study officials:
affiliation: B+L
name: Anya Loncaric
role: STUDY_DIRECTOR
References: