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CataractNCT04192630

A Study of B + L Ophthalmic Viscosurgical Device (OVD) CVisc50

A study testing CVisc50 OVD, ProVisc OVD and Cataract Surgery in people with Cataract, run by Bausch & Lomb Incorporated at 22 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 years and older
Conditions the study is for
Cataract
What is being tested?
CVisc50 OVD, ProVisc OVD and Cataract Surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
390 participants
Where
22 sitesUnited States
Study dates
26 Nov 2019to 31 Jan 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 19Show fewer
  • 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.

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

United States22 sites

  • Bausch Site 019

    Bloomington, Minnesota, 55420

  • Bausch Site 010

    Burlingame, California, 94010

  • Bausch Site 009

    Cedar Park, Texas, 78613

  • Bausch Site 017

    Chandler, Arizona, 85224

  • Bausch Site 008

    Fayetteville, Arkansas, 72704

  • Bausch Site 007

    Garden Grove, California, 92843

  • Bausch Site 014

    Goodlettsville, Tennessee, 37073

  • Bausch Site 006

    Houston, Texas, 77008

  • Bausch Site 020

    Kansas City, Missouri, 64154

  • Bausch Site 021

    Mason, Ohio, 45040

  • Bausch 018

    Nashville, Tennessee, 37215

  • Bausch Site 005

    New York, New York, 10013

  • Bausch Site 011

    Newport Beach, California, 92662

  • Bausch Site 012

    Northridge, California, 91325

  • Bausch Site 001

    Phoenix, Arizona, 85032

  • Bausch Site 013

    Rancho Cordova, California, 95670

  • Bausch Site 003

    Reading, Pennsylvania, 96002

  • Bausch 022

    San Antonio, Texas, 78215

  • Bausch Site 016

    San Antonio, Texas, 78229

  • Bausch Site 002

    St Louis, Missouri, 63131

  • Bausch Site 004

    Torrance, California, 90505

  • Bausch Site 015

    Washington, Missouri, 63090

Other trials in United States

About this study

Official title: A Study to Document the Safety and Effectiveness of a New Cohesive OVD When Compared to a Control OVD

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.

Read the 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.

Conditions
Cataract
Being tested
CVisc50 OVD, ProVisc OVD, Cataract Surgery
Medical subject headings
Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CVisc50 OVDDevice

    Also called Bausch + Lomb CVisc50 Cohesive OVD

    Bausch + Lomb CVisc50 Cohesive OVD

  • ProVisc OVDDevice

    Also called Alcon ProVisc® OVD

    ProVisc OVD

  • Cataract SurgeryProcedure or surgery

    Cataract Surgery

Study groups in NCT04192630
Study groupRoleWhat they receive
CVisc50 Ophthalmic Viscosurgical Device (OVD)ExperimentalCVisc50 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.
Receives: Device: CVisc50 OVD; Procedure: Cataract Surgery
ProVisc OVDActive comparatorProVisc 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.
Receives: Device: ProVisc OVD; Procedure: Cataract Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Who Experienced at Least One Intraocular Pressure (IOP) Measurement ≥30 Millimeters of Mercury (mmHg) at Any Post-Surgical Follow-up Visit

    Measured: Up to 90 Days ± 14 Days

  2. Change From Baseline in Corneal Endothelial Cell Density (ECD) in the Study Eye at Postoperative Visit 5 (90 Days ± 14 Days)

    Measured: Baseline, 90 Days ± 14 Days

Secondary outcomes (3)

  1. Mean Change From Baseline in IOP at the 6-Hour Post-Operative Visit

    Measured: Baseline, 6-hour post-operative

  2. Mean Change From Baseline in IOP at the 24-Hour Post-Operative Visit

    Measured: Baseline, 24-hour post-operative

  3. 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.

    Measured: 6-hour and 24-hour post-operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2019
  2. Study start26 Nov 2019
  3. Primary completion31 Jan 2022
  4. Study completion31 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
390 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04192630
Sponsor's protocol ID
878
Status last verified
Dec 2022
First submitted
6 Dec 2019
Last updated
28 May 2024
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Packer M, Shultz M, Loden J, Lau G. Safety and effectiveness comparison of a new cohesive ophthalmic viscosurgical device. J Cataract Refract Surg. 2023 Aug 1;49(8):804-811. doi: 10.1097/j.jcrs.0000000000001201.

    PubMed 37079390

Questions about this trial

What is this clinical trial studying?

A study testing CVisc50 OVD, ProVisc OVD and Cataract Surgery in people with Cataract, run by Bausch & Lomb Incorporated at 22 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Up to 90 Days ± 14 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04192630, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.

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