CClinicalTrials.gg
Sign In
CompletedNCT02006888Updated Apr 23, 2018Results posted

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

A Phase 3 interventional study of IBI-10090 and Placebo in Inflammation and Cataracts, sponsored by ICON Bioscience Inc. Completed at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2018-04-23.

Sponsored by ICON Bioscience Inc · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
394
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study summary

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

Read the 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)

02

Conditions studied

  • Inflammation
  • Cataracts

Keywords

  • Inflammation
  • cataract surgery
03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 394 is above the median of 80 across 1,155 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

ICON Bioscience Inc is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
394 participants (actual)

Study arms

  • 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

Interventions

  • DrugIBI-10090

    Also known as: Dexycu

  • DrugPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Day 8

07

Results

Posted Apr 23, 2018

Participant flow

The first patient was enrolled into the study on 19 December 2013 and the last patient completed the study on 03 October 2014.

Participant flow — Overall Study
MilestoneIBI-10090 Low DoseIBI-10090 Med DosePlacebo
Started15815680
Completed12212258
Not completed363422

Outcome measures

PrimaryNumber 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).

Time frame:
Day 8
Reported as:
Count of participants · Participants
Number of Participants With Anterior Chamber Cell Clearing
ParticipantsIBI-10090 Low DoseIBI-10090 Med DosePlacebo
Number of Participants With Anterior Chamber Cell Clearing9910320

Adverse events

Non-serious events are listed at a 2.5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
IBI-10090 Low Dose0/158 (0%)1/158 (0.6%)16/158 (10.1%)
IBI-10090 Med Dose0/156 (0%)0/156 (0%)4/156 (2.6%)
Placebo0/80 (0%)0/80 (0%)7/80 (8.8%)
Most frequent serious events
Most frequent serious events
EventIBI-10090 Low DoseIBI-10090 Med DosePlacebo
Corneal decompensationEye disorders1/1580/1560/80
Most frequent other events
Most frequent other events
EventIBI-10090 Low DoseIBI-10090 Med DosePlacebo
eye painEye disorders16/1584/1567/80

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)IBI-10090 Low DoseIBI-10090 Med DosePlaceboTotal
<=18 years0000
Between 18 and 65 years41411799
>=65 years11711563295
Age, Continuous
Age, Continuous(years)IBI-10090 Low DoseIBI-10090 Med DosePlaceboTotal
Mean70 ± 970 ± 971 ± 970 ± 9
Sex: Female, Male
Sex: Female, Male(Participants)IBI-10090 Low DoseIBI-10090 Med DosePlaceboTotal
Female756939183
Male838741211
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)IBI-10090 Low DoseIBI-10090 Med DosePlaceboTotal
Hispanic or Latino19231456
Not Hispanic or Latino13913366338
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)IBI-10090 Low DoseIBI-10090 Med DosePlaceboTotal
American Indian or Alaska Native1304
Asian4116
Native Hawaiian or Other Pacific Islander2103
Black or African American17211149
White12912367319
More than one race0000
Unknown or Not Reported57113
Region of Enrollment
Region of Enrollment(participants)IBI-10090 Low DoseIBI-10090 Med DosePlaceboTotal
United States15815680394
08

Study locations

1 site
  • Hull Eye Center
    Lancaster, California 93534, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02006888
Lead sponsor
ICON Bioscience Inc
Responsible party
Sponsor
First posted
Dec 10, 2013
Start date
Jan 2014
Primary completion
Oct 2014
Completion
Oct 2014
Results posted
Apr 23, 2018
Last update
Apr 23, 2018

Study contacts

howard franklin, md
study director · ICON Bioscience Inc
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Cataract→

Other studies from this sponsor

ICON Bioscience Inc

Start the discussion