CataractPhase 3NCT02547623
Study to Evaluate the Safety for the Treatment of Inflammation Associated With Cataract Surgery
A Phase 3 study testing Dexamethasone and Prednisolone in people with Cataract, run by ICON Bioscience Inc at 11 sites in United States.
Trial summary
The study is a prospective, randomized, parallel-design, multicenter trial in patients ≥40 years of age undergoing cataract surgery. Patients who meet all inclusion and no exclusion criteria will be randomized to 1 of 2 treatment groups A single 5 mcl anterior chamber injection of IBI 10090, 103.4 mcg/mcl… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Dexamethasone and Prednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 11 sitesUnited States
- Study dates
- 6 Nov 2015to 16 Aug 2016
- Phase
- Phase 3
- 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
- undergoing cataract surgery
Who cannot join
- glaucoma patient, pregnancy, allergy to dexamethasone
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Cincinnati Eye Institute
Cincinnati, Ohio, 45242
Cincinnati Eye Institute
Edgewood, Kentucky, 41017
Ophthalmic Consultants of Long Island
Garden City, New York, 11530
Kislinger MD inc
Glendora, California, 91741
Inland Eye Specialists
Hemet, California, 92545
Harvard Eye Associated
Laguna Hills, California, 92653
Carolina Eye Care Physicians
Mt. Pleasant, South Carolina, 29464
Feinerman Vision Center
Newport Beach, California, 92663
Matossian Eye Associates
Pennington, New Jersey, 08534
the eye institute of Utah
Salt Lake City, Utah, 84107
Associated Eye Care
Stillwater, Minnesota, 55082
About this study
Official title: A Phase 3, Prospective, Randomized, Parallel-design, Multicenter Study to Evaluate the Safety of Icon Bioscience-10090 for the Treatment of Inflammation Associated With Cataract Surgery
The study is a prospective, randomized, parallel-design, multicenter trial in patients ≥40 years of age undergoing cataract surgery. Patients who meet all inclusion and no exclusion criteria will be randomized to 1 of 2 treatment groups
- A single 5 mcl anterior chamber injection of IBI 10090, 103.4 mcg/mcl dexamethasone, equivalent dexamethasone dose: 517 mcg at the conclusion of cataract surgery or;
- Prednisolone acetate ophthalmic suspension 1% eye drops administered 1 drop 4 times daily (QID) for 3 weeks Safety will be assessed by adverse events (AEs), slit lamp biomicroscopy, fundus examination, intraocular pressure (IOP), visual acuity, and specular microscopy endothelial cell count.
Read the detailed description
The study is a prospective, randomized, parallel-design, multicenter trial in patients ≥40 years of age undergoing cataract surgery. Patients who meet all inclusion and no exclusion criteria will be randomized to 1 of 2 treatment groups
- A single 5 mcl anterior chamber injection of IBI 10090, 103.4 mcg/mcl dexamethasone, equivalent dexamethasone dose: 517 mcg at the conclusion of cataract surgery or;
- Prednisolone acetate ophthalmic suspension 1% eye drops administered 1 drop 4 times daily (QID) for 3 weeks
- Conditions
- Cataract
- Being tested
- Dexamethasone, Prednisolone
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Dexycu
depot intracameral
PrednisoloneDrug
Also called standard of care
Prednisolone eye drops 1%
| Study group | Role | What they receive |
|---|---|---|
| dexamethasone depot | Active comparator | dexamethasone depot 517 mcg Receives: Drug: Dexamethasone |
| standard of care | Active comparator | prednisolone drops 1% Receives: Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Treatment-emergent Adverse Events were defined as events that started after the study drug administration, and occurred before termination of the study, or were present before study drug administration and worsened after dose administration.
Measured: Baseline to postoperative day 90/ early termination
Secondary outcomes (12)
Intraocular Pressure Measurement
Intraocular Pressure was measured by Goldmann applanation tonometry.
Measured: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination
Visual Acuity in Study Eye
Visual Acuity assessed by the Snellen chart, was expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1
Measured: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination
Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade
Slit lamp biomicroscopy of the anterior chamber was performed using a slit beam of 1-mm height and 1-mm width with maximum luminance through the highest-powered lens using the Investigator's standard slit lamp equipment and procedure.
Conjunctiva hyperemia slit lamp results were summarized by treatment group and time point.
Measured: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination
Slit Lamp Biomicroscopy - Cornea Edema Grade
Slit lamp biomicroscopy of the anterior chamber was performed using a slit beam of 1-mm height and 1-mm width with maximum luminance through the highest-powered lens using the Investigator's standard slit lamp equipment and procedure.
Cornea edema slit lamp results in the study eye were summarized by treatment group and time point.
Measured: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination
Summary of Concomitant Medications Used in the Study Eye or Both Eyes
Measured: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination
Changes in the Corneal Endothelial Cell Count
Corneal Endothelial Cell Density was measured by specular microscopy.
Measured: Baseline, Postoperative day 90/Early termination
Optic Disc Cup-disc Ratio for the Study Eye
Calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc).
Measured: Baseline, POD 90/Early termination
Dilated Opthalmoscopy Findings - Optic Disc (Study Eye)
The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's optic disc
Measured: Baseline, POD 90/Early termination
Dilated Opthalmoscopy Findings - Retina (Study Eye)
The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's retina
Measured: Baseline, POD 90/Early termination
Dilated Opthalmoscopy Findings - Macula (Study Eye)
The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's macula.
Measured: Baseline, POD 90/Early termination
Dilated Opthalmoscopy Findings - Choroid (Study Eye)
The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's choroid
Measured: Baseline, POD 90/Early termination
Dilated Opthalmoscopy Findings - Vitreous (Study Eye)
The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's vitreous
Measured: Baseline, POD 90/Early termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study start6 Nov 2015
- Primary completion16 Aug 2016
- Study completion16 Aug 2016
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 CataractStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- ICON Bioscience Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Donnenfeld, MD, Principal investigator, Ophthalmic Consultants of Long Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02547623
- Sponsor's protocol ID
- C15-01
- Status last verified
- Jul 2018
- First submitted
- 9 Sep 2015
- Last updated
- 21 Aug 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 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Prospective, Randomized, Parallel-design, Multicenter Study to Evaluate the Safety of Icon Bioscience-10090 for the Treatment of Inflammation Associated With Cataract Surgery
- ClinicalTrials.gov ID
- NCT02547623
- Acronym / sponsor ID
- C15-01
- Conditions
- Cataract
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- ICON Bioscience IncIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2015 (actual)
- Primary completion
- 16 Aug 2016 (actual)
- Study completion
- 16 Aug 2016 (actual)
- First posted
- 11 Sep 2015 (estimated)
- Results
- Posted 19 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a prospective, randomized, parallel-design, multicenter trial in patients ≥40 years of age undergoing cataract surgery. Patients who meet all inclusion and no exclusion criteria will be randomized to 1 of 2 treatment groups
- A single 5 mcl anterior chamber injection of IBI 10090, 103.4 mcg/mcl dexamethasone, equivalent dexamethasone dose: 517 mcg at the conclusion of cataract surgery or;
- Prednisolone acetate ophthalmic suspension 1% eye drops administered 1 drop 4 times daily (QID) for 3 weeks Safety will be assessed by adverse events (AEs), slit lamp biomicroscopy, fundus examination, intraocular pressure (IOP), visual acuity, and specular microscopy endothelial cell count.
Detailed description
The study is a prospective, randomized, parallel-design, multicenter trial in patients ≥40 years of age undergoing cataract surgery. Patients who meet all inclusion and no exclusion criteria will be randomized to 1 of 2 treatment groups
- A single 5 mcl anterior chamber injection of IBI 10090, 103.4 mcg/mcl dexamethasone, equivalent dexamethasone dose: 517 mcg at the conclusion of cataract surgery or;
- Prednisolone acetate ophthalmic suspension 1% eye drops administered 1 drop 4 times daily (QID) for 3 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexamethasone depot | Active comparator | Drug: Dexamethasonedexamethasone depot 517 mcg |
| standard of care | Active comparator | Drug: Prednisoloneprednisolone drops 1% |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- undergoing cataract surgery
Key exclusion criteria (1 listed)
- glaucoma patient, pregnancy, allergy to dexamethasone
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 |
|---|---|---|
| DexamethasoneAlso: Dexycudepot intracameral | Drug | dexamethasone depot |
| PrednisoloneAlso: standard of carePrednisolone eye drops 1% | Drug | standard of care |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Baseline to postoperative day 90/ early termination
Treatment-emergent Adverse Events were defined as events that started after the study drug administration, and occurred before termination of the study, or were present before study drug administration and worsened after dose administration.
12 secondary outcomes
Intraocular Pressure Measurement
Time frame: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination
Visual Acuity in Study Eye
Time frame: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination
Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade
Time frame: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination
Slit Lamp Biomicroscopy - Cornea Edema Grade
Time frame: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination
Summary of Concomitant Medications Used in the Study Eye or Both Eyes
Time frame: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination
Changes in the Corneal Endothelial Cell Count
Time frame: Baseline, Postoperative day 90/Early termination
Optic Disc Cup-disc Ratio for the Study Eye
Time frame: Baseline, POD 90/Early termination
Dilated Opthalmoscopy Findings - Optic Disc (Study Eye)
Time frame: Baseline, POD 90/Early termination
Dilated Opthalmoscopy Findings - Retina (Study Eye)
Time frame: Baseline, POD 90/Early termination
Dilated Opthalmoscopy Findings - Macula (Study Eye)
Time frame: Baseline, POD 90/Early termination
Dilated Opthalmoscopy Findings - Choroid (Study Eye)
Time frame: Baseline, POD 90/Early termination
Dilated Opthalmoscopy Findings - Vitreous (Study Eye)
Time frame: Baseline, POD 90/Early termination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
- 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.
Eric Donnenfeld, MD principal investigator
Ophthalmic Consultants of Long Island
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone and Prednisolone in people with Cataract, run by ICON Bioscience Inc at 11 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 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 19 Jun 2018). 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?
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: Baseline to postoperative day 90/ early termination). 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 21 Aug 2018.