Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT03511638
NCT03511638CompletedNot Applicable

A Study to Document the Safety and Effectiveness of a New OVD When Compared to a Control OVD

Bausch & Lomb Incorporated2 sites in 1 country372 target enrollmentStarted: May 9, 2018Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
372
Locations
2
Primary Endpoint
Percent Change in Mean Epithelial Cell Density (ECD)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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®).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
45 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts 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.
  • •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.
  • •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
  • •The subject must have clear intraocular media other than the cataract in the operative eye.

Exclusion Criteria

  • •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.
  • •The subject has any corneal pathology (e.g., significant scarring, guttata, inflammation, edema, dystrophy, etc.) in the operative eye.
  • •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.
  • •The subject has any condition which prevents reliable specular microscopy in the operative eye.

Outcomes

Primary Outcomes

Percent Change in Mean Epithelial Cell Density (ECD)

Time Frame: Day 90

Percentage of Participants With Postoperative Intraocular Pressure of at Least 30 mm Hg

Time Frame: 90 days

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

Loading locations...

Similar Trials

Terminated
Not Applicable
Viveye Ocular Magnetic Neurostimulation System (OMNS) for the Management of Severe Dry Eye DiseaseSjogren's SyndromeDry Eye SyndromesATD
NCT04143841Epitech Mag Ltd.50
Completed
Phase 3
Efficacy and Safety of Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D) for Reduction of Lymphatic Leakage by Sealing Axillary Lymph Node Dissection SitesLumpectomyMastectomy Plus Axillary Lymph Node DissectionLymphatic LeakageBreast Cancer
NCT00161980Baxter Healthcare Corporation
Unknown
Not Applicable
Study of Different Endoscopic Preparations Used in Pediatric ColonoscopyDigestive Illness
NCT04153084Fundación Pública Andaluza para la gestión de la Investigación en Sevilla126
Not yet recruiting
Not Applicable
A study to see the effect of 2 chemotherapy drugs- Cyclophosphamide and Methotrexate when given in a low dose form in women having Metastatic Triple Negative Breast cancer
CTRI/2015/07/006016Jehangir Clinical Development centre Pvt ltd40
Terminated
Phase 2
Percutaneous Dynamic Stabilization (PDS) System Versus Fusion for Treating Degenerative Disc DiseaseLumbar Degenerative Disc Disease
NCT00878579Interventional Spine, Inc.20