Bausch & Lomb Ophthalmic Viscosurgical Device (OVD) Dispersive (DVisc40)

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

Detailed Description
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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®).

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

Conditions
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Cataract

Intervention / Treatment
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* Device: Bausch & Lomb DVisc40
* Device: Alcon VISCOAT®


Participation Criteria
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Eligibility Criteria
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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. 2. 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. 3. 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 4. The subject must have clear intraocular media other than the cataract in the operative eye. Exclusion Criteria: 1. 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. 2. The subject has any corneal pathology (e.g., significant scarring, guttata, inflammation, edema, dystrophy, etc.) in the operative eye. 3. 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. 4. The subject has any condition which prevents reliable specular microscopy in the operative eye.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: a multicenter, controlled, randomized, monocular trial of Bausch & Lomb DVisc40 (test) OVD compared to the currently marketed Alcon VISCOAT® (control) OVD
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bausch & Lomb DVisc40<br>Ophthalmic viscosurgical device | Device: Bausch & Lomb DVisc40<br>* Ophthalmic viscosurgical device<br>|
| Active Comparator: Alcon VISCOAT®<br>Ophthalmic viscosurgical device | Device: Alcon VISCOAT®<br>* Ophthalmic viscosurgical device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Mean Epithelial Cell Density (ECD) |  | Day 90 | 
| Percentage of Participants With Postoperative Intraocular Pressure of at Least 30 mm Hg |  | 90 days |