Inflammation Associated With Cataract SurgeryPhase 2NCT01606735
Efficacy and Safety of IBI-10090 in Ocular Surgery Patients
A Phase 2 study testing IBI-10090 in people with Inflammation Associated With Cataract Surgery, run by ICON Bioscience Inc at 2 sites in United States.
Trial summary
This study will test the efficacy and safety of IBI-10090 in the treatment of ocular inflammation after ocular surgery. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Inflammation Associated With Cataract Surgery
- What is being tested?
- IBI-10090
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2012to Mar 2013
- 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
- Patients scheduled for unilateral cataract surgery
Who cannot join
- Ocular, topical, or oral corticosteroids within 7 days of Day 0
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Inland Eye Specialists
Hemet, California, 92545
California Eye Professionals
Temecula, California, 92591
About this study
Official title: A Multicenter, Randomized, Double-masked, Dose-ranging, Phase 2 Study to Evaluate the Efficacy and Safety of IBI-10090 for the Treatment of Inflammation Associated With Ocular Surgery
This study will test the efficacy and safety of IBI-10090 in the treatment of ocular inflammation after ocular surgery.
- Being tested
- IBI-10090
- Keywords
- cataract surgery, ocular inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI-10090Drug
dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 | Experimental | Not described Receives: Drug: IBI-10090 |
| Dose 2 | Experimental | Not described Receives: Drug: IBI-10090 |
| Dose 3 | Experimental | Not described Receives: Drug: IBI-10090 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior Chamber Cell Count at Day 8 Post-Treatment
This study will measure as its primary endpoint the anterior chamber cell count at Day 8 post-treatment. The proportion of patients with anterior chamber cell count = 0 at Day 8 for each dosage group will be compared.
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 posted28 May 2012 (estimated)
- Study startApr 2012
- Primary completionMar 2013
- Study completionMar 2013
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 Inflammation Associated With Cataract SurgeryStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- ICON Bioscience Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wendy Murahashi, MD, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01606735
- Sponsor's protocol ID
- C11-01
- Status last verified
- Sep 2014
- First submitted
- 24 May 2012
- Last updated
- 22 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2014. 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 for the Treatment of Inflammation Associated With Ocular Surgery
- ClinicalTrials.gov ID
- NCT01606735
- Acronym / sponsor ID
- C11-01
- Keywords
- cataract surgery, ocular inflammation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- ICON Bioscience IncIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 28 May 2012 (estimated)
- Results
- Posted 22 Sep 2014
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 ocular surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose 1 | Experimental | Drug: IBI-10090 |
| Dose 2 | Experimental | Drug: IBI-10090 |
| Dose 3 | Experimental | Drug: IBI-10090 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for unilateral cataract surgery
Key exclusion criteria (1 listed)
- Ocular, topical, or oral corticosteroids within 7 days of Day 0
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-10090dexamethasone | Drug | Dose 1, Dose 2, Dose 3 |
Primary outcome
Anterior Chamber Cell Count 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. The proportion of patients with anterior chamber cell count = 0 at Day 8 for each dosage group will be compared.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Wendy Murahashi, MD study director
Sponsor GmbH
2 sites 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 Inflammation Associated With Cataract Surgery, run by ICON Bioscience Inc at 2 sites 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 1 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: finished, as of the sponsor's last update on 22 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 22 Sep 2014). 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?
Anterior Chamber Cell Count 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 22 Sep 2014.