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The Efficacy and Safety of IBI-10090 for the Treatment of Inflammation Associated With Cataract Surgery

Primary Purpose

Inflammation, Cataracts

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

IBI-10090

Placebo

About this trial

This is an interventional treatment trial for Inflammation focused on measuring Inflammation, cataract surgery

Eligibility Criteria

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

Inclusion Criteria:

The patient must provide written informed consent by signing the Informed Consent approved by the Institutional Review Board (IRB).
Male or female patients at least 40 years of age scheduled for unilateral cataract surgery by phacoemulsification with posterior chamber intraocular lens implantation.
The patient must demonstrate best corrected visual acuity (BCVA) of 20/30-20/200 (with glare testing, if necessary) in the study eye and better than 20/200 in the fellow eye.
The patient must be considered by the Investigator to have visual acuity potential greater than 20/30 in the study eye.
The patient must have a corneal endothelial cell count by specular microscopy in the study eye of at least 2000 cells/mm2 with normal cell morphology.
A female patient of childbearing potential (premenopausal by medical history) must have a negative pregnancy test on Day 0 and be using an effective method of birth control (although no birth control method is 100% effective, the following are considered effective means of contraception: surgical sterilization, use of oral contraceptives, barrier contraception using either a condom or diaphragm with spermicidal gel, an intrauterine device, or contraceptive hormone implant or patch) from Screening for the duration of the study.
The patient must be willing and able to understand and comply with the study procedures and to communicate meaningfully with study personnel.

Key Exclusion Criteria:

Patients who have used any ocular, topical or oral corticosteroids within 7 days prior to Day 0.
Patients who have received a periocular corticosteroid injection in the study eye in the 3 months prior to screening.
Patients who have received any intravitreal corticosteroid delivery vehicle (e.g., Retisert, Ozurdex, Iluvien) in the study eye at any time.
Patients who anticipate requiring treatment with any corticosteroids by any route, except inhalation, during the study.
Patients with an allergy or hypersensitivity to dexamethasone.
Patients who are known steroid responders (corticosteroid-related intraocular pressure elevation in either eye).
Patients who have used topical ocular NSAIDs in the study eye within 15 days prior to Day 0.
Patients who have undergone prior intraocular (non-laser) surgery in the study eye within 6 months prior to screening.
Patients who have undergone prior intraocular laser surgery in the study eye within 3 months prior to screening.
Patients with planned intraocular or laser surgery in the study eye for the duration of the study.

Sites / Locations

Hull Eye Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

IBI-10090 low dose

IBI-10090 med dose

Placebo

Arm Description

IBI-10090 low dose

IBI-10090 med dose

Placebo

Outcomes

Primary Outcome Measures

Number of Participants With Anterior Chamber Cell Clearing

The primary efficacy outcome is anterior chamber cell clearing in the study eye at Day 8. The slit lamp examination for anterior chamber cells (ACC) is a recognized way to measure inflammation in the anterior chamber. During the slit lamp examination, the number of anterior chamber cells are quantified and graded: grade 0 (absent, 0 cells), grade 1 (1 to 5 cells), grade 2 (6 to 15 cells), grade 3 (16 to 30+ cells), or grade 4 (hypopyon). Anterior chamber cell clearing occurs when all the ACC are absent (grade 0).

Secondary Outcome Measures

Full Information

NCT ID

NCT02006888

First Posted

December 5, 2013

Last Updated

March 23, 2018

Sponsor

ICON Bioscience Inc

1. Study Identification

Unique Protocol Identification Number

NCT02006888

Brief Title

The Efficacy and Safety of IBI-10090 for the Treatment of Inflammation Associated With Cataract Surgery

Official Title

The Efficacy and Safety of IBI-10090 for the Treatment of Inflammation Associated With Cataract Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

January 2014 (undefined)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ICON Bioscience Inc

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to determine whether IBI-10090 injection is effective in the treatment of inflammation associated with cataract surgery.

Detailed Description

A double blinded randomized trial to assess the efficacy and safety of IBI-10090, in two separate doses as compared to placebo (ATEC carrier only sans dexamethasone)

6. Conditions and Keywords

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

Inflammation, Cataracts

Keywords

Inflammation, cataract surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

394 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IBI-10090 low dose

Arm Type

Experimental

Arm Description

IBI-10090 low dose

Arm Title

IBI-10090 med dose

Arm Type

Experimental

Arm Description

IBI-10090 med dose

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

IBI-10090

Other Intervention Name(s)

Dexycu

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Number of Participants With Anterior Chamber Cell Clearing

Description

Time Frame

Day 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The patient must provide written informed consent by signing the Informed Consent approved by the Institutional Review Board (IRB). Male or female patients at least 40 years of age scheduled for unilateral cataract surgery by phacoemulsification with posterior chamber intraocular lens implantation. The patient must demonstrate best corrected visual acuity (BCVA) of 20/30-20/200 (with glare testing, if necessary) in the study eye and better than 20/200 in the fellow eye. The patient must be considered by the Investigator to have visual acuity potential greater than 20/30 in the study eye. The patient must have a corneal endothelial cell count by specular microscopy in the study eye of at least 2000 cells/mm2 with normal cell morphology. A female patient of childbearing potential (premenopausal by medical history) must have a negative pregnancy test on Day 0 and be using an effective method of birth control (although no birth control method is 100% effective, the following are considered effective means of contraception: surgical sterilization, use of oral contraceptives, barrier contraception using either a condom or diaphragm with spermicidal gel, an intrauterine device, or contraceptive hormone implant or patch) from Screening for the duration of the study. The patient must be willing and able to understand and comply with the study procedures and to communicate meaningfully with study personnel. Key Exclusion Criteria: Patients who have used any ocular, topical or oral corticosteroids within 7 days prior to Day 0. Patients who have received a periocular corticosteroid injection in the study eye in the 3 months prior to screening. Patients who have received any intravitreal corticosteroid delivery vehicle (e.g., Retisert, Ozurdex, Iluvien) in the study eye at any time. Patients who anticipate requiring treatment with any corticosteroids by any route, except inhalation, during the study. Patients with an allergy or hypersensitivity to dexamethasone. Patients who are known steroid responders (corticosteroid-related intraocular pressure elevation in either eye). Patients who have used topical ocular NSAIDs in the study eye within 15 days prior to Day 0. Patients who have undergone prior intraocular (non-laser) surgery in the study eye within 6 months prior to screening. Patients who have undergone prior intraocular laser surgery in the study eye within 3 months prior to screening. Patients with planned intraocular or laser surgery in the study eye for the duration of the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

howard franklin, md

Organizational Affiliation

ICON Bioscience Inc

Official's Role

Study Director

Facility Information:

Facility Name

Hull Eye Center

City

Lancaster

State/Province

California

ZIP/Postal Code

93534

Country

United States

12. IPD Sharing Statement

Learn more about this trial

The Efficacy and Safety of IBI-10090 for the Treatment of Inflammation Associated With Cataract Surgery

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