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N/A N=390 Randomized Double-blind Treatment

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

Cataract

Enrolled (actual)
390
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: 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 — 10; 16 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
CVisc50 OVD (Device); ProVisc OVD (Device); Cataract Surgery (Procedure)
Age
Adult, Older Adult · 45+ yrs
Sex
All
Sponsor
Bausch & Lomb Incorporated
Primary completion
Jan 2022

Outcome Measures

OutcomeResultp-value
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
10; 16
PRIMARY
Change From Baseline in Corneal Endothelial Cell Density (ECD) in the Study Eye at Postoperative Visit 5 (90 Days ± 14 Days)
15.7; 15.8
SECONDARY
Mean Change From Baseline in IOP at the 6-Hour Post-Operative Visit
19.5; 20.0; 3.8; 4.2
SECONDARY
Mean Change From Baseline in IOP at the 24-Hour Post-Operative Visit
18.0; 18.4; 2.3; 2.6
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
177; 187; 183; 184

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.

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 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04192630). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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