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Study to Evaluate the Safety for the Treatment of Inflammation Associated With Cataract Surgery

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: NCT02547623
Recruitment Status : Completed
First Posted : September 11, 2015
Results First Posted : June 19, 2018
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
ICON Bioscience Inc

Tracking Information
First Submitted Date  ICMJE September 9, 2015
First Posted Date  ICMJE September 11, 2015
Results First Submitted Date  ICMJE April 6, 2018
Results First Posted Date  ICMJE June 19, 2018
Last Update Posted Date August 21, 2018
Actual Study Start Date  ICMJE November 6, 2015
Actual Primary Completion Date August 16, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2018)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Baseline to postoperative day 90/ early termination ]
Treatment-emergent Adverse Events were defined as events that started after the study drug administration, and occurred before termination of the study, or were present before study drug administration and worsened after dose administration.
Original Primary Outcome Measures  ICMJE
 (submitted: September 10, 2015)
Endothelial cell count as measured by specular microscopy [ Time Frame: 90 days post op ]
Change History Complete list of historical versions of study NCT02547623 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2018)
  • Intraocular Pressure Measurement [ Time Frame: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination ]
    Intraocular Pressure was measured by Goldmann applanation tonometry.
  • Visual Acuity in Study Eye [ Time Frame: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination ]
    Visual Acuity assessed by the Snellen chart, was expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1
  • Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade [ Time Frame: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination ]
    Slit lamp biomicroscopy of the anterior chamber was performed using a slit beam of 1-mm height and 1-mm width with maximum luminance through the highest-powered lens using the Investigator's standard slit lamp equipment and procedure. Conjunctiva hyperemia slit lamp results were summarized by treatment group and time point.
  • Slit Lamp Biomicroscopy - Cornea Edema Grade [ Time Frame: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination ]
    Slit lamp biomicroscopy of the anterior chamber was performed using a slit beam of 1-mm height and 1-mm width with maximum luminance through the highest-powered lens using the Investigator's standard slit lamp equipment and procedure. Cornea edema slit lamp results in the study eye were summarized by treatment group and time point.
  • Summary of Concomitant Medications Used in the Study Eye or Both Eyes [ Time Frame: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination ]
  • Changes in the Corneal Endothelial Cell Count [ Time Frame: Baseline, Postoperative day 90/Early termination ]
    Corneal Endothelial Cell Density was measured by specular microscopy.
  • Optic Disc Cup-disc Ratio for the Study Eye [ Time Frame: Baseline, POD 90/Early termination ]
    Calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc).
  • Dilated Opthalmoscopy Findings - Optic Disc (Study Eye) [ Time Frame: Baseline, POD 90/Early termination ]
    The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's optic disc
  • Dilated Opthalmoscopy Findings - Retina (Study Eye) [ Time Frame: Baseline, POD 90/Early termination ]
    The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's retina
  • Dilated Opthalmoscopy Findings - Macula (Study Eye) [ Time Frame: Baseline, POD 90/Early termination ]
    The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's macula.
  • Dilated Opthalmoscopy Findings - Choroid (Study Eye) [ Time Frame: Baseline, POD 90/Early termination ]
    The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's choroid
  • Dilated Opthalmoscopy Findings - Vitreous (Study Eye) [ Time Frame: Baseline, POD 90/Early termination ]
    The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's vitreous
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 Study to Evaluate the Safety for the Treatment of Inflammation Associated With Cataract Surgery
Official Title  ICMJE A Phase 3, Prospective, Randomized, Parallel-design, Multicenter Study to Evaluate the Safety of Icon Bioscience-10090 for the Treatment of Inflammation Associated With Cataract Surgery
Brief Summary

The study is a prospective, randomized, parallel-design, multicenter trial in patients ≥40 years of age undergoing cataract surgery. Patients who meet all inclusion and no exclusion criteria will be randomized to 1 of 2 treatment groups

  • A single 5 mcl anterior chamber injection of IBI 10090, 103.4 mcg/mcl dexamethasone, equivalent dexamethasone dose: 517 mcg at the conclusion of cataract surgery or;
  • Prednisolone acetate ophthalmic suspension 1% eye drops administered 1 drop 4 times daily (QID) for 3 weeks Safety will be assessed by adverse events (AEs), slit lamp biomicroscopy, fundus examination, intraocular pressure (IOP), visual acuity, and specular microscopy endothelial cell count.
Detailed Description

The study is a prospective, randomized, parallel-design, multicenter trial in patients ≥40 years of age undergoing cataract surgery. Patients who meet all inclusion and no exclusion criteria will be randomized to 1 of 2 treatment groups

  • A single 5 mcl anterior chamber injection of IBI 10090, 103.4 mcg/mcl dexamethasone, equivalent dexamethasone dose: 517 mcg at the conclusion of cataract surgery or;
  • Prednisolone acetate ophthalmic suspension 1% eye drops administered 1 drop 4 times daily (QID) for 3 weeks
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cataract
Intervention  ICMJE
  • Drug: Dexamethasone
    depot intracameral
    Other Name: Dexycu
  • Drug: Prednisolone
    Prednisolone eye drops 1%
    Other Name: standard of care
Study Arms  ICMJE
  • Active Comparator: dexamethasone depot
    dexamethasone depot 517 mcg
    Intervention: Drug: Dexamethasone
  • Active Comparator: standard of care
    prednisolone drops 1%
    Intervention: Drug: Prednisolone
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 21, 2018)
194
Original Estimated Enrollment  ICMJE
 (submitted: September 10, 2015)
180
Actual Study Completion Date  ICMJE August 16, 2016
Actual Primary Completion Date August 16, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • undergoing cataract surgery

Exclusion Criteria:

  • glaucoma patient, pregnancy, allergy to dexamethasone
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT02547623
Other Study ID Numbers  ICMJE C15-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ICON Bioscience Inc
Study Sponsor  ICMJE ICON Bioscience Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eric Donnenfeld, MD Ophthalmic Consultants of Long Island
PRS Account ICON Bioscience Inc
Verification Date July 2018

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