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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

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.

Condition or disease Intervention/treatment Phase
Cataract Drug: Dexamethasone Drug: Prednisolone Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 194 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 6, 2015
Actual Primary Completion Date : August 16, 2016
Actual Study Completion Date : August 16, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Active Comparator: dexamethasone depot
dexamethasone depot 517 mcg
Drug: Dexamethasone
depot intracameral
Other Name: Dexycu

Active Comparator: standard of care
prednisolone drops 1%
Drug: Prednisolone
Prednisolone eye drops 1%
Other Name: standard of care




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.


  4. 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.


  5. 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 ]
  6. Changes in the Corneal Endothelial Cell Count [ Time Frame: Baseline, Postoperative day 90/Early termination ]
    Corneal Endothelial Cell Density was measured by specular microscopy.

  7. 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).

  8. 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

  9. 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

  10. 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.

  11. 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

  12. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • undergoing cataract surgery

Exclusion Criteria:

  • glaucoma patient, pregnancy, allergy to dexamethasone

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): NCT02547623


Locations
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United States, California
Kislinger MD inc
Glendora, California, United States, 91741
Inland Eye Specialists
Hemet, California, United States, 92545
Harvard Eye Associated
Laguna Hills, California, United States, 92653
Feinerman Vision Center
Newport Beach, California, United States, 92663
United States, Kentucky
Cincinnati Eye Institute
Edgewood, Kentucky, United States, 41017
United States, Minnesota
Associated Eye Care
Stillwater, Minnesota, United States, 55082
United States, New Jersey
Matossian Eye Associates
Pennington, New Jersey, United States, 08534
United States, New York
Ophthalmic Consultants of Long Island
Garden City, New York, United States, 11530
United States, Ohio
Cincinnati Eye Institute
Cincinnati, Ohio, United States, 45242
United States, South Carolina
Carolina Eye Care Physicians
Mount Pleasant, South Carolina, United States, 29464
United States, Utah
the eye institute of Utah
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
ICON Bioscience Inc
Investigators
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Principal Investigator: Eric Donnenfeld, MD Ophthalmic Consultants of Long Island

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Responsible Party: ICON Bioscience Inc
ClinicalTrials.gov Identifier: NCT02547623     History of Changes
Other Study ID Numbers: C15-01
First Posted: September 11, 2015    Key Record Dates
Results First Posted: June 19, 2018
Last Update Posted: August 21, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
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Inflammation
Cataract
Pathologic Processes
Lens Diseases
Eye Diseases
Dexamethasone
Dexamethasone acetate
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents