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

Primary Purpose

Cataract

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Dexamethasone

Prednisolone

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

undergoing cataract surgery

Exclusion Criteria:

glaucoma patient, pregnancy, allergy to dexamethasone

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

dexamethasone depot

standard of care

Arm Description

dexamethasone depot 517 mcg

prednisolone drops 1%

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Intraocular Pressure Measurement

Intraocular Pressure was measured by Goldmann applanation tonometry.

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

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.

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.

Summary of Concomitant Medications Used in the Study Eye or Both Eyes

Changes in the Corneal Endothelial Cell Count

Corneal Endothelial Cell Density was measured by specular microscopy.

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).

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

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

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.

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

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

Full Information

NCT ID

NCT02547623

First Posted

September 9, 2015

Last Updated

July 24, 2018

Sponsor

ICON Bioscience Inc

1. Study Identification

Unique Protocol Identification Number

NCT02547623

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

November 6, 2015 (Actual)

Primary Completion Date

August 16, 2016 (Actual)

Study Completion Date

August 16, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ICON Bioscience Inc

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

194 (Actual)

8. Arms, Groups, and Interventions

Arm Title

dexamethasone depot

Arm Type

Active Comparator

Arm Description

dexamethasone depot 517 mcg

Arm Title

standard of care

Arm Type

Active Comparator

Arm Description

prednisolone drops 1%

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Other Intervention Name(s)

Dexycu

Intervention Description

depot intracameral

Intervention Type

Drug

Intervention Name(s)

Prednisolone

Other Intervention Name(s)

standard of care

Intervention Description

Prednisolone eye drops 1%

Primary Outcome Measure Information:

Title

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Description

Time Frame

Baseline to postoperative day 90/ early termination

Secondary Outcome Measure Information:

Title

Intraocular Pressure Measurement

Description

Intraocular Pressure was measured by Goldmann applanation tonometry.

Time Frame

Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination

Title

Visual Acuity in Study Eye

Description

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

Time Frame

Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination

Title

Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade

Description

Time Frame

Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination

Title

Slit Lamp Biomicroscopy - Cornea Edema Grade

Description

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.

Time Frame

Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination

Title

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

Title

Changes in the Corneal Endothelial Cell Count

Description

Corneal Endothelial Cell Density was measured by specular microscopy.

Time Frame

Baseline, Postoperative day 90/Early termination

Title

Optic Disc Cup-disc Ratio for the Study Eye

Description

Calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc).

Time Frame