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

• ClinicalTrials.gov Identifier: NCT02006888
• Recruitment Status: Completed
• First Posted: December 10, 2013
• Results First Posted: April 23, 2018
• Last Update Posted: April 23, 2018
• Sponsor: ICON Bioscience Inc
• Information provided by (Responsible Party): ICON Bioscience Inc

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.

Condition or disease	Intervention/treatment	Phase
Inflammation; Cataracts	Drug: IBI-10090; Drug: Placebo	Phase 3

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)

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 394 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Efficacy and Safety of IBI-10090 for the Treatment of Inflammation Associated With Cataract Surgery
• Study Start Date: January 2014
• Actual Primary Completion Date: October 2014
• Actual Study Completion Date: October 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: IBI-10090 low dose; IBI-10090 low dose	Drug: IBI-10090; Other Name: Dexycu
Experimental: IBI-10090 med dose; IBI-10090 med dose	Drug: IBI-10090; Other Name: Dexycu
Placebo Comparator: Placebo; Placebo	Drug: Placebo; Placebo

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Anterior Chamber Cell Clearing [ Time Frame: Day 8 ]
   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).

Eligibility Criteria

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

Criteria

Inclusion Criteria:

1. The patient must provide written informed consent by signing the Informed Consent approved by the Institutional Review Board (IRB).
2. Male or female patients at least 40 years of age scheduled for unilateral cataract surgery by phacoemulsification with posterior chamber intraocular lens implantation.
3. 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.
4. The patient must be considered by the Investigator to have visual acuity potential greater than 20/30 in the study eye.
5. 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.
6. 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.
7. 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:

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

Contacts and Locations

Locations

United States, California

Hull Eye Center

Lancaster, California, United States, 93534

Sponsors and Collaborators

ICON Bioscience Inc

Investigators

• Study Director: howard franklin, md; ICON Bioscience Inc

More Information

• Responsible Party: ICON Bioscience Inc
• ClinicalTrials.gov Identifier: NCT02006888
• Other Study ID Numbers: C13-04
• First Posted: December 10, 2013
• Results First Posted: April 23, 2018
• Last Update Posted: April 23, 2018
• Last Verified: March 2018

Keywords provided by ICON Bioscience Inc:

Inflammation; cataract surgery

Additional relevant MeSH terms:

Cataract; Inflammation; Pathologic Processes; Lens Diseases; Eye Diseases