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

Cataract Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02547623
• Other study ID #: C15-01
• Status: Completed
• Phase: Phase 3
• Start date: November 6, 2015
• Est. completion date: August 16, 2016

Study information

• Verified date: July 2018
• Source: ICON Bioscience Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: August 16, 2016
• Est. primary completion date: August 16, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• undergoing cataract surgery

Exclusion Criteria:

• glaucoma patient, pregnancy, allergy to dexamethasone

Related Conditions & MeSH terms

• Cataract
• Inflammation

Intervention

Drug:
• Dexamethasone
depot intracameral
• Prednisolone
Prednisolone eye drops 1%

Locations

Country	Name	City	State
United States	Cincinnati Eye Institute	Cincinnati	Ohio
United States	Cincinnati Eye Institute	Edgewood	Kentucky
United States	Ophthalmic Consultants of Long Island	Garden City	New York
United States	Kislinger MD inc	Glendora	California
United States	Inland Eye Specialists	Hemet	California
United States	Harvard Eye Associated	Laguna Hills	California
United States	Carolina Eye Care Physicians	Mount Pleasant	South Carolina
United States	Feinerman Vision Center	Newport Beach	California
United States	Matossian Eye Associates	Pennington	New Jersey
United States	the eye institute of Utah	Salt Lake City	Utah
United States	Associated Eye Care	Stillwater	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
ICON Bioscience Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Intraocular Pressure Measurement	Intraocular Pressure was measured by Goldmann applanation tonometry.	Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination
Secondary	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
Secondary	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
Secondary	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
Secondary	Summary of Concomitant Medications Used in the Study Eye or Both Eyes		Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination
Secondary	Changes in the Corneal Endothelial Cell Count	Corneal Endothelial Cell Density was measured by specular microscopy.	Baseline, Postoperative day 90/Early termination
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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