Ocular InflammationPhase 2NCT01214174
Efficacy and Safety Study of IBI-10090 in Cataract Surgery Patients
A Phase 2 study testing IBI-10090 in people with Ocular Inflammation, run by ICON Bioscience Inc at 1 site in United States.
Trial summary
This study will test the efficacy and safety of IBI-10090 in the treatment of ocular inflammation after cataract surgery. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Ocular Inflammation
- What is being tested?
- IBI-10090
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to May 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients 40 years of age scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation.
Who cannot join
- Patients who have used any ocular, topical, or oral corticosteroids within 7 days prior to Day 0.
- Patients who have used topical ocular NSAIDs in the study eye within 15 days prior to screening.
- Patients with any signs of intraocular inflammation in either eye at screening.
- Patients who have received any prior intravitreal injections in the study eye.
Trial locations and contacts
1 site in 1 country.
United States1 site
Drs. Fine, Hoffman, and Packer
Eugene, Oregon, 97401
About this study
Official title: A Multicenter, Randomized, Double-masked, Dose-ranging, Phase 2 Study to Evaluate the Efficacy and Safety of IBI-10090 in Treating Inflammation in Cataract Surgery Patients
This study will test the efficacy and safety of IBI-10090 in the treatment of ocular inflammation after cataract surgery.
- Conditions
- Ocular Inflammation
- Being tested
- IBI-10090
- Keywords
- cataract, inflammation
- Medical subject headings
- Cataract, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI-10090Drug
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 | Experimental | 513ug Receives: Drug: IBI-10090 |
| Dose 2 | Experimental | 776ug Receives: Drug: IBI-10090 |
| Dose 3 | Experimental | 1046ug Receives: Drug: IBI-10090 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients With Anterior Chamber Cell Clearing at Day 8 Post-Treatment
This study will measure as its primary endpoint the anterior chamber cell count at Day 8 post-treatment in the study eye. The proportion of patients with anterior chamber cell count = 0 at Day 8 in the study eye for each dosage group will be compared. Only one eye was treated per participant.
Measured: 8 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionMay 2012
- Study completionMay 2012
Why it stopped: Study C11-01 started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ocular InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- ICON Bioscience Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Packer, MD, Principal investigator, Drs. Fine, Hoffman, Packer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01214174
- Sponsor's protocol ID
- C10-01
- Status last verified
- Sep 2013
- First submitted
- 21 Sep 2010
- Last updated
- 18 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-masked, Dose-ranging, Phase 2 Study to Evaluate the Efficacy and Safety of IBI-10090 in Treating Inflammation in Cataract Surgery Patients
- ClinicalTrials.gov ID
- NCT01214174
- Acronym / sponsor ID
- C10-01
- Conditions
- Ocular Inflammation
- Keywords
- cataract, inflammation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study C11-01 started
- Enrolment
- 42 participants (actual)
- Lead sponsor
- ICON Bioscience IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 4 Oct 2010 (estimated)
- Results
- Posted 18 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the efficacy and safety of IBI-10090 in the treatment of ocular inflammation after cataract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose 1 | Experimental | Drug: IBI-10090513ug |
| Dose 2 | Experimental | Drug: IBI-10090776ug |
| Dose 3 | Experimental | Drug: IBI-100901046ug |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female patients 40 years of age scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation.
Key exclusion criteria (4 listed)
- Patients who have used any ocular, topical, or oral corticosteroids within 7 days prior to Day 0.
- Patients who have used topical ocular NSAIDs in the study eye within 15 days prior to screening.
- Patients with any signs of intraocular inflammation in either eye at screening.
- Patients who have received any prior intravitreal injections in the study eye.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IBI-10090 | Drug | Dose 1, Dose 2, Dose 3 |
Primary outcome
Proportion of Patients With Anterior Chamber Cell Clearing at Day 8 Post-Treatment
Time frame: 8 days post-treatment
This study will measure as its primary endpoint the anterior chamber cell count at Day 8 post-treatment in the study eye. The proportion of patients with anterior chamber cell count = 0 at Day 8 in the study eye for each dosage group will be compared. Only one eye was treated per participant.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Packer, MD principal investigator
Drs. Fine, Hoffman, Packer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IBI-10090 in people with Ocular Inflammation, run by ICON Bioscience Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients With Anterior Chamber Cell Clearing at Day 8 Post-Treatment (time frame: 8 days post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2013.