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NCT04316936 · ClinicalTrials.gov registry record · Phase 4
Omidria and Dexycu, or Omidria and Dextenza Compared to Topical Prednisolone Acetate 1% Following Cataract Surgery
A Phase 4 study of Cataract Surgery, sponsored by Silverstein Eye Centers.
- Completed
- Registry status
- Phase 4
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT04316936: Completed Phase 4 study of Cataract Surgery, sponsored by Silverstein Eye Centers.
NCT04316936 is a Phase 4 study of Cataract Surgery that has completed, run by Silverstein Eye Centers. The registered enrollment target is 15 participants, below the 144-participant average among 7 other Cataract Surgery trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04316936, a Phase 4 study of Cataract Surgery, has completed, sponsored by Silverstein Eye Centers.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
This research will evaluate the efficacy of Omidria and Dexycu, Omidria and Dextenza, and Omidria and prednisolone acetate 1% in the resolution of post-operative inflammation and pain following cataract surgery.
Primary Outcome
The primary efficacy end point is the complete resolution of anterior chamber inflammation (cell and flare). This is a non-contact, non-invasive test performed by the physician using a slit lamp. The evaluation requires less than one minute.
Conditions Studied
Interventions
- DRUG Prednisolone Acetate 1%
- DRUG Omidria
- DRUG Dextenza (dexamethasone ophthalmic insert) 0.4mg
- DRUG Dexycu, 9% Intraocular Suspension
Study Locations (1)
Missouri
- Silverstein Eye Centers - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2019-12-10 |
| Est. Completion | 2020-12-23 |
| Phase | Phase 4 |
What the finished NCT04316936 record still lists
NCT04316936 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 144-participant average among 7 other Cataract Surgery trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Cataract Surgery appearing as the primary indexed condition, and to 4 interventions - of which Prednisolone Acetate 1% is the first listed.
NCT04316936 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT04316936 about?
NCT04316936 is a clinical study titled "Omidria and Dexycu, or Omidria and Dextenza Compared to Topical Prednisolone Acetate 1% Following Cataract Surgery". This research will evaluate the efficacy of Omidria and Dexycu, Omidria and Dextenza, and Omidria and prednisolone acetate 1% in the resolution of post-operative inflammation and pain following cataract surgery.
What is the current status of trial NCT04316936?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 15 participants. The study started on 2019-12-10. Estimated completion is 2020-12-23.
What conditions does trial NCT04316936 study?
This clinical trial studies the following conditions: Cataract Surgery.
What interventions are being tested in trial NCT04316936?
The interventions under investigation include: Prednisolone Acetate 1% (DRUG), Omidria (DRUG), Dextenza (dexamethasone ophthalmic insert) 0.4mg (DRUG), Dexycu, 9% Intraocular Suspension (DRUG).
Who is sponsoring clinical trial NCT04316936?
This trial is sponsored by Silverstein Eye Centers, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04316936 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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