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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 23, 2016
First Posted Date  ICMJE May 25, 2016
Results First Submitted Date  ICMJE April 13, 2018
Results First Posted Date  ICMJE May 24, 2018
Last Update Posted Date May 24, 2018
Actual Study Start Date  ICMJE June 21, 2016
Actual Primary Completion Date May 4, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2018)
  • 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%.
  • 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%.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT02782676 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2018)
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Investigation of the Bacterially-Derived Healon5 Ophthalmic Viscosurgical Device (OVD)
Official Title  ICMJE Clinical Investigation of the Bacterially-Derived Healon5 Ophthalmic Viscosurgical Device (OVD)
Brief Summary Prospective, multicenter, paired-eye, randomized, masked, clinical trial of the bacterially-derived Healon5 OVD versus the currently available Healon5 OVD control.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cataract
Intervention  ICMJE
  • Device: Investigational Healon5 OVD
    ophthalmic viscosurgical device
  • Device: Healon5 OVD
    ophthalmic viscosurgical device
Study Arms  ICMJE
  • Experimental: Investigational Healon5 OVD
    Subjects to receive investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.
    Intervention: Device: Investigational Healon5 OVD
  • Active Comparator: Approved Healon5 OVD
    Subjects to receive investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.
    Intervention: Device: Healon5 OVD
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 22, 2018)
241
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 4, 2017
Actual Primary Completion Date May 4, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02782676
Other Study ID Numbers  ICMJE VSCO-109-HLN5
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Serious adverse event or other adverse event data and other data as needed.
Responsible Party Abbott Medical Optics
Study Sponsor  ICMJE Abbott Medical Optics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Kendra Hileman, PhD Abbott Medical Optics
PRS Account Abbott Medical Optics
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP