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

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

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Drug: Dexamethasone; Drug: Prednisolone

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: Interventional
• Enrollment (Actual): 194
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Glendora, California, United States, 91741
      • Kislinger MD inc
    • Hemet, California, United States, 92545
      • Inland Eye Specialists
    • Laguna Hills, California, United States, 92653
      • Harvard Eye Associated
    • Newport Beach, California, United States, 92663
      • Feinerman Vision Center
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • Cincinnati Eye Institute
  • Minnesota
    • Stillwater, Minnesota, United States, 55082
      • Associated Eye Care
  • New Jersey
    • Pennington, New Jersey, United States, 08534
      • Matossian Eye Associates
  • New York
    • Garden City, New York, United States, 11530
      • Ophthalmic Consultants of Long Island
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Cincinnati Eye Institute
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • Carolina Eye Care Physicians
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • The Eye Institute of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• undergoing cataract surgery

Exclusion Criteria:

• glaucoma patient, pregnancy, allergy to dexamethasone

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: dexamethasone depot; dexamethasone depot 517 mcg	Drug: Dexamethasone; depot intracameral; Other Names: Dexycu
Active Comparator: standard of care; prednisolone drops 1%	Drug: Prednisolone; Prednisolone eye drops 1%; Other Names: standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	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.	Baseline to postoperative day 90/ early termination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular Pressure Measurement	Intraocular Pressure was measured by Goldmann applanation tonometry.	Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination
Visual Acuity in Study Eye	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	Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination
Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	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.	Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination
Slit Lamp Biomicroscopy - Cornea Edema Grade	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.	Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination
Summary of Concomitant Medications Used in the Study Eye or Both Eyes		Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination
Changes in the Corneal Endothelial Cell Count	Corneal Endothelial Cell Density was measured by specular microscopy.	Baseline, Postoperative day 90/Early termination
Optic Disc Cup-disc Ratio for the Study Eye	Calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc).	Baseline, POD 90/Early termination
Dilated Opthalmoscopy Findings - Optic Disc (Study Eye)	The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's optic disc	Baseline, POD 90/Early termination
Dilated Opthalmoscopy Findings - Retina (Study Eye)	The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's retina	Baseline, POD 90/Early termination
Dilated Opthalmoscopy Findings - Macula (Study Eye)	The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's macula.	Baseline, POD 90/Early termination
Dilated Opthalmoscopy Findings - Choroid (Study Eye)	The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's choroid	Baseline, POD 90/Early termination
Dilated Opthalmoscopy Findings - Vitreous (Study Eye)	The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's vitreous	Baseline, POD 90/Early termination

Collaborators and Investigators

• Sponsor: ICON Bioscience Inc

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2015
• Primary Completion (Actual): August 16, 2016
• Study Completion (Actual): August 16, 2016

Study Registration Dates

• First Submitted: September 9, 2015
• First Submitted That Met QC Criteria: September 10, 2015
• First Posted (Estimate): September 11, 2015

Study Record Updates

• Last Update Posted (Actual): August 21, 2018
• Last Update Submitted That Met QC Criteria: July 24, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Lens Diseases; Inflammation; Cataract; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone; Prednisolone
• Other Study ID Numbers: C15-01