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History of Changes for Study: NCT02006888
The Efficacy and Safety of IBI-10090 for the Treatment of Inflammation Associated With Cataract Surgery
Latest version (submitted March 23, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 9, 2013 None (earliest Version on record)
2 January 22, 2014 Recruitment Status, Study Status and Contacts/Locations
3 September 2, 2014 Recruitment Status, Study Status and Contacts/Locations
4 March 23, 2015 Recruitment Status, Study Status, Study Design
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Results Submission Events
5 March 23, 2018 Study Status, Outcome Measures, Results, Contacts/Locations, Arms and Interventions, Study Description and Study Identification
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Study NCT02006888
Submitted Date:  December 9, 2013 (v1)

Open or close this module Study Identification
Unique Protocol ID: C13-04
Brief Title: The Efficacy and Safety of IBI-10090 for the Treatment of Inflammation Associated With Cataract Surgery
Official Title:
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2013
Overall Status: Not yet recruiting
Study Start: December 2013
Primary Completion: September 2014 [Anticipated]
Study Completion:
First Submitted: December 5, 2013
First Submitted that
Met QC Criteria:
December 9, 2013
First Posted: December 10, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:
December 9, 2013
Last Update Posted: December 10, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: ICON Bioscience Inc
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module 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:
Open or close this module Conditions
Conditions: Inflammation
Cataracts
Keywords: Inflammation
cataract surgery
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 352 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: IBI-10090 low dose
IBI-10090 low dose
Drug: IBI-10090
Experimental: IBI-10090 med dose
IBI-10090 med dose
Drug: IBI-10090
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo
Open or close this module Outcome Measures
Primary Outcome Measures:
1. The primary efficacy outcome is anterior chamber cell clearing (ACC = 0) in the study eye at Day 8.
[ Time Frame: Day 8 ]

Open or close this module Eligibility
Minimum Age: 40 Years
Maximum Age:
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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