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NCT02547623 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Safety for the Treatment of Inflammation Associated With Cataract Surgery
A Phase 3 study, sponsored by ICON Bioscience.
- Completed
- Registry status
- Phase 3
- Development phase
- 194
- Enrollment target
NCT02547623: Completed Phase 3 study, sponsored by ICON Bioscience.
NCT02547623 is a Phase 3 study that has completed, run by ICON Bioscience. The registered enrollment target is 194 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02547623, a Phase 3 study, has completed, sponsored by ICON Bioscience.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 194 participants
- Enrollment target
Study 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 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.
Primary Outcome
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.
Interventions
- DRUG Dexamethasone
- DRUG Prednisolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 194 participants |
| Start Date | 2015-11-06 |
| Est. Completion | 2016-08-16 |
| Phase | Phase 3 |
What the finished NCT02547623 record still lists
NCT02547623 is an interventional study that assigns participants to a tested intervention. The registered 194 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 2 interventions - of which Dexamethasone is the first listed.
NCT02547623 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02547623 about?
NCT02547623 is a clinical study titled "Study to Evaluate the Safety 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....
What is the current status of trial NCT02547623?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 194 participants. The study started on 2015-11-06. Estimated completion is 2016-08-16.
What interventions are being tested in trial NCT02547623?
The interventions under investigation include: Dexamethasone (DRUG), Prednisolone (DRUG).
Who is sponsoring clinical trial NCT02547623?
This trial is sponsored by ICON Bioscience, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02547623's enrollment target sits among peer trials
194 1395th of 2000 higher than 604 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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