Bausch & Lomb Ophthalmic Viscosurgical Device (OVD) Dispersive (DVisc40)
A Study to Document the Safety and Effectiveness of a New OVD When Compared to a Control OVD
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
San Diego, California, United States, 22434
- Valeant Site 01
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Bausch & Lomb DVisc40
Ophthalmic viscosurgical device
|
Ophthalmic viscosurgical device
|
|
ACTIVE_COMPARATOR: Alcon VISCOAT®
Ophthalmic viscosurgical device
|
Ophthalmic viscosurgical device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percent Change in Mean Epithelial Cell Density (ECD)
Time Frame: Day 90
|
Day 90
|
|
Percentage of Participants With Postoperative Intraocular Pressure of at Least 30 mm Hg
Time Frame: 90 days
|
90 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S877
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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