Clinical Investigation of the Bacterially-Derived Healon5 Ophthalmic Viscosurgical Device (OVD)
NCT02782676 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 241
Last updated 2025-02-04
Summary
Prospective, multicenter, paired-eye, randomized, masked, clinical trial of the bacterially-derived Healon5 OVD versus the currently available Healon5 OVD control.
Conditions
- Cataract
Interventions
- DEVICE
-
Investigational Healon5 OVD
ophthalmic viscosurgical device
- DEVICE
-
Healon5 OVD
ophthalmic viscosurgical device
Sponsors & Collaborators
-
Abbott Medical Optics
lead INDUSTRY
Principal Investigators
-
Kendra Hileman, PhD · Abbott Medical Optics
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 22 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-06-21
- Primary Completion
- 2017-05-04
- Completion
- 2017-05-04
- FDA Device
- Yes
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