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Clinical Investigation of the Bacterially-Derived Healon5 Ophthalmic Viscosurgical Device (OVD)

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ClinicalTrials.gov Identifier: NCT02782676
Recruitment Status : Completed
First Posted : May 25, 2016
Results First Posted : May 24, 2018
Last Update Posted : May 24, 2018
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics

Brief Summary:
Prospective, multicenter, paired-eye, randomized, masked, clinical trial of the bacterially-derived Healon5 OVD versus the currently available Healon5 OVD control.

Condition or disease Intervention/treatment Phase
Cataract Device: Investigational Healon5 OVD Device: Healon5 OVD Not Applicable

Detailed Description:
This study will include only subjects undergoing bilateral, primary, cataract extraction and intraocular lens (IOL) implantation and who meet all of the study inclusion and exclusion criteria in both eyes. Subjects who meet the inclusion/exclusion criteria and agree to participate will be randomly assigned to receive the investigational OVD in one eye and the currently-available (i.e., commercial) OVD in the fellow eye (control). Thus, a single group of subjects will provide data for both the investigational OVD and the control OVD.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 241 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Investigation of the Bacterially-Derived Healon5 Ophthalmic Viscosurgical Device (OVD)
Actual Study Start Date : June 21, 2016
Actual Primary Completion Date : May 4, 2017
Actual Study Completion Date : May 4, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Investigational Healon5 OVD
Subjects to receive investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.
Device: Investigational Healon5 OVD
ophthalmic viscosurgical device

Active Comparator: Approved Healon5 OVD
Subjects to receive investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.
Device: Healon5 OVD
ophthalmic viscosurgical device




Primary Outcome Measures :
  1. Cumulative Rates of Intraocular Pressure (IOP) Spikes 30mm of Mercury (mmHg) or Greater Measured Postoperatively [ Time Frame: 3 months ]
    The cumulative rate of IOP spikes with the bacterially-derived Healon5 will be statistically non-inferior to that with the animal-derived Healon5 control using a non-inferiority margin of 10%.

  2. Mean Percent Endothelial Cell Count (ECC) Change Preoperatively vs. Postoperatively [ Time Frame: 3 months ]
    The mean percent ECC change with the bacterially-derived Healon5 will be statistically non-inferior to that with the animal-derived Healon5 control using a non-inferiority margin of 5%.


Secondary Outcome Measures :
  1. Ocular Serious Adverse Events (SAE) [ Time Frame: 3 months ]

    Ocular serious and/or device related adverse event rates was be tabulated with the frequency and proportion of eyes with these events reported over time and cumulatively by OVD group.

    * in the results table denotes SAEs determined to be device-related


  2. Mean Change in IOP From Baseline [ Time Frame: 3 months ]
    The mean change in IOP from baseline for both OVD groups over time at the 6 hour, 1 day, 1 week, 1 month, and 3 month postoperative time points are presented.

  3. Rate of IOP Spikes 30 mmHg or Greater at 3 Month Postoperatively [ Time Frame: 3 months ]
    The rate of IOP spike 30 mmHg or greater at 6 hour, 1 day, 1 week, 1 month and 3 months postoperatively was tabulated with frequency and proportion by OVD group.

  4. Grade of Inflammation: Epithelial Edema [ Time Frame: Upto 3 months ]
    The grades of inflammation for epithelial edema was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.

  5. Grade of Inflammation: Stromal Edema [ Time Frame: Upto 3 months ]
    The grades of inflammation for stromal edema was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.

  6. Grade of Inflammation: Cells [ Time Frame: Upto 3 months ]
    The grades of inflammation for cells was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.

  7. Grade of Inflammation: Flare [ Time Frame: Upto 3 months ]
    The grades of inflammation for flare was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.

  8. Grade of Inflammation: Anterior Synechiae [ Time Frame: Upto 3 months ]
    The grades of inflammation for Anterior Synechiae was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.

  9. Grade of Inflammation: Posterior Synechiae [ Time Frame: Upto 3 Months ]
    The grades of inflammation for Posterior Synechiae was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.

  10. Grade of Inflammation: Fibrin Presence [ Time Frame: Upto 3 Months ]
    The grades of inflammation for Fibrin Presence was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Minimum 22 years of age
  • Cataracts for which extraction and posterior IOL implantation have been planned for both eyes
  • Potential for postoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or better
  • Clear intraocular media, other than cataract
  • Availability, willingness and sufficient cognitive awareness to comply with examination procedures
  • Signed informed consent and HIPAA authorization

Exclusion Criteria:

  • Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)
  • Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject
  • Prior corneal refractive (LASIK- laser-assisted in situ keratomileusis, LASEK-laser-assisted sub-epithelial keratectomy, RK- radial keratectomy, PRK- photorefractive keratectomy, etc.) or intraocular surgery
  • Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level worse than 20/40 Snellen during the study
  • Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity losses to a level worse than 20/40 Snellen during the study.
  • Conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as pseudoexfoliation, trauma, or posterior capsule defects
  • Use of systemic or ocular medications that may affect vision
  • Prior, current, or anticipated use during the course of the 3-month study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) that may, in the opinion of the investigator, confound the outcome or increase the risk to the subject (e.g., poor dilation or a lack of adequate iris structure to perform standard cataract surgery)
  • Poorly-controlled diabetes
  • Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.).
  • Known steroid responder
  • Ocular hypertension of ≥ 20 mmHg, medically-controlled ocular hypertension (regardless of IOP value ), or glaucomatous changes in the optic nerve
  • Endothelial cell count (ECC) lower than 1800 cells/mm2 preoperatively (based on the lowest value of the three cell counts as taken by the Konan Specular Microscope)
  • Known ocular disease or pathology that may affect visual acuity or that may be expected to require retinal laser treatment or other surgical intervention during the course of the study (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.)
  • Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes
  • Concurrent participation, or participation within 45 days prior to preoperative visit, in any other clinical trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02782676


Locations
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United States, California
Empire Eye & Laser Center
Bakersfield, California, United States, 93309
United States, Florida
Cape Coral Eye Center
Cape Coral, Florida, United States, 33904
Katzen Eye Care & Laser Center
West Palm Beach, Florida, United States, 33401
United States, Pennsylvania
Scott & Christie and Associates
Cranberry Township, Pennsylvania, United States, 16066
United States, Tennessee
Loden Vision Center
Goodlettsville, Tennessee, United States, 37072
United States, Texas
Whitsett Vision Group
Houston, Texas, United States, 77084
Parkhurst NuVision
San Antonio, Texas, United States, 78229
United States, Washington
Clarus Eye Centre
Lacey, Washington, United States, 98503
Sponsors and Collaborators
Abbott Medical Optics
Investigators
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Study Director: Kendra Hileman, PhD Abbott Medical Optics
  Study Documents (Full-Text)

Documents provided by Abbott Medical Optics:
Study Protocol  [PDF] September 21, 2016
Statistical Analysis Plan  [PDF] January 22, 2016


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Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT02782676     History of Changes
Other Study ID Numbers: VSCO-109-HLN5
First Posted: May 25, 2016    Key Record Dates
Results First Posted: May 24, 2018
Last Update Posted: May 24, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Serious adverse event or other adverse event data and other data as needed.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents