Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04539548 · ClinicalTrials.gov registry record · Phase 3
A Study Assessing the Safety and Efficacy of Dextenza® for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract
A Phase 3 study of Cataract, sponsored by Ocular Therapeutix.
- Completed
- Registry status
- Phase 3
- Development phase
- 65
- Enrollment target
- 14
- Study locations
NCT04539548 is a Phase 3 study of Cataract that has completed, run by Ocular Therapeutix. The registered enrollment target is 65 participants, below the 228-participant average among 83 other Cataract trials with a reported enrollment target (71% lower). The trial reports 14 study locations across 12 states.
The verdict
NCT04539548, a Phase 3 study of Cataract, has completed, sponsored by Ocular Therapeutix.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 65 participants
- Enrollment target
- 14
- Study locations
Study Summary
To assess the safety of Dextenza compared to an active control, prednisolone acetate suspension, for the treatment of postoperative pain and inflammation following ocular surgery for pediatric cataract.
Conditions Studied
Interventions
- DRUG Dextenza Ophthalmic Insert
- DRUG Prednisolone acetate ophthalmic suspension USP 1%
Study Locations (14)
Colorado
- Ocular Therapeutix - Aurora
- Ocular Therapeutix - Fort Collins
Minnesota
- Ocular Therapeutix - Minneapolis
- Ocular Therapeutix - Rochester
Florida
- Ocular Therapeutix - Jacksonville
Indiana
- Ocular Therapeutix - Indianapolis
Kentucky
- Ocular Therapeutix - Lexington
Massachusetts
- Ocular Therapeutix - Boston
Missouri
- Ocular Therapeutix - St Louis
Pennsylvania
- Ocular Therapeutix - Erie
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2020-09-04 |
| Est. Completion | 2023-12-21 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04539548
The ClinicalTrials.gov registry entry for NCT04539548 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 228-participant average among 83 other Cataract trials with a reported enrollment target (71% lower). The listed sponsor is Ocular Therapeutix, which has 20 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cataract appearing as the primary indexed condition, and to 2 interventions - of which Dextenza Ophthalmic Insert is the first listed.
NCT04539548 reports 14 study locations spanning 12 distinct geographic areas - top geographies include Colorado, Minnesota, Florida.
Frequently Asked Questions
What is clinical trial NCT04539548 about?
NCT04539548 is a clinical study titled "A Study Assessing the Safety and Efficacy of Dextenza® for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract". To assess the safety of Dextenza compared to an active control, prednisolone acetate suspension, for the treatment of postoperative pain and inflammation following ocular surgery for pediatric cataract.
What is the current status of trial NCT04539548?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 65 participants. The study started on 2020-09-04. Estimated completion is 2023-12-21.
What conditions does trial NCT04539548 study?
This clinical trial studies the following conditions: Cataract.
What interventions are being tested in trial NCT04539548?
The interventions under investigation include: Dextenza Ophthalmic Insert (DRUG), Prednisolone acetate ophthalmic suspension USP 1% (DRUG).
Who is sponsoring clinical trial NCT04539548?
This trial is sponsored by Ocular Therapeutix, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04539548 being conducted?
This trial has 14 study locations across Colorado, Florida, Indiana, Kentucky, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cataract
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Study to Evaluate Efficacy and Safety of MELT-300 for Procedural Sedation in Subjects Undergoing Cataract Extraction With Lens Replacement (CELR)
RECRUITING · Phase 3
-
Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhine)
RECRUITING · Phase 3
-
Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhone)
RECRUITING · Phase 3
-
Safety and Efficacy of a Violet Visible Light Blocking Intraocular Lens (IOL)
COMPLETED · Phase 3
-
Efficacy and Safety of XG-102 in Reduction of Post-cataract Surgery Intraocular Inflammation
COMPLETED · Phase 3
-
Study of T-PRED(TM) Compared to Pred Forte(R) II
COMPLETED · Phase 3
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.