Inflammatory Reaction Due to Ocular Lens ProsthesisPhase 2NCT01048593
Efficacy and Safety Study of IBI-10090 in Patients Undergoing Cataract Surgery
A Phase 2 study testing IBI-10090 in people with Inflammatory Reaction Due to Ocular Lens Prosthesis, run by ICON Bioscience Inc at 1 site in United States.
Trial summary
This study will test the efficacy and safety of IBI-10090 for the reduction 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
- Inflammatory Reaction Due to Ocular Lens Prosthesis
- What is being tested?
- IBI-10090
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jun 2010
- 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.
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 Cataract Surgery Patients
This study will test the efficacy and safety of IBI-10090 for the reduction of ocular inflammation after cataract surgery.
Read the detailed description
All patients received active treatment in this study. Dose group 1 received 114ug of dexamethasone, Dose group 2 received 513ug and Dose group 3 received 684ug.
- Being tested
- IBI-10090
- Keywords
- ocular inflammation cataract surgery, post cataract surgery inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI-10090Drug
Single intraocular injection
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 | Experimental | 114ug Receives: Drug: IBI-10090 |
| Dose 2 | Experimental | 513ug Receives: Drug: IBI-10090 |
| Dose 3 | Experimental | 684ug Receives: Drug: IBI-10090 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance of Anterior Chamber Cells
Efficacy was assessed by slit lamp biomicroscopy to evaluate the anterior chamber cells (ACC) graded on a scale of 0 to 4. The primary efficacy endpoint was complete clearing of ACC, where grade 0 = 0 cells in the anterior chamber on POD 8.
Measured: Day 8 post treatment
Secondary outcomes (4)
Anterior Chamber Flare (ACF) Grade
Efficacy was assessed by slit lamp biomicroscopy to evaluate the anterior chamber flare (ACF) graded on a scale of 0 to 4.
Measured: Day 90 post-treatment
Conjunctival Erythema Grade
Conjunctival erythema was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 3.
Measured: Day 90 post-treatment
Corneal Edema Grade
Cornea edema was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 3.
Measured: Day 90 post-treatment
Anterior Chamber Cell Grade
Anterior chamber cells (ACC) grade was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 4.
Measured: Day 90 post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionMay 2010
- Study completionJun 2010
Why it stopped: Study was terminated in order to examine study data.
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 Inflammatory Reaction Due to Ocular Lens ProsthesisStudies 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- ICON Bioscience Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Chang, MD, Principal investigator, Altos Eye Physicians
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01048593
- Sponsor's protocol ID
- C09-01
- Status last verified
- Nov 2018
- First submitted
- 11 Jan 2010
- Last updated
- 4 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. 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 Cataract Surgery Patients
- ClinicalTrials.gov ID
- NCT01048593
- Acronym / sponsor ID
- C09-01
- Keywords
- ocular inflammation cataract surgery, post cataract surgery inflammation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated in order to examine study data.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- ICON Bioscience IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 13 Jan 2010 (estimated)
- Results
- Posted 16 Aug 2012
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 for the reduction of ocular inflammation after cataract surgery.
Detailed description
All patients received active treatment in this study. Dose group 1 received 114ug of dexamethasone, Dose group 2 received 513ug and Dose group 3 received 684ug.
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-10090114ug |
| Dose 2 | Experimental | Drug: IBI-10090513ug |
| Dose 3 | Experimental | Drug: IBI-10090684ug |
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-10090Single intraocular injection | Drug | Dose 1, Dose 2, Dose 3 |
Primary outcome
Clearance of Anterior Chamber Cells
Time frame: Day 8 post treatment
Efficacy was assessed by slit lamp biomicroscopy to evaluate the anterior chamber cells (ACC) graded on a scale of 0 to 4. The primary efficacy endpoint was complete clearing of ACC, where grade 0 = 0 cells in the anterior chamber on POD 8.
4 secondary outcomes
Anterior Chamber Flare (ACF) Grade
Time frame: Day 90 post-treatment
Conjunctival Erythema Grade
Time frame: Day 90 post-treatment
Corneal Edema Grade
Time frame: Day 90 post-treatment
Anterior Chamber Cell Grade
Time frame: Day 90 post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2018.
- 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.
David Chang, MD principal investigator
Altos Eye Physicians
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 Inflammatory Reaction Due to Ocular Lens Prosthesis, 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 4 Dec 2018. 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 16 Aug 2012). 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?
Clearance of Anterior Chamber Cells (time frame: Day 8 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 4 Dec 2018.