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: Completed Phase 3 study of Cataract, sponsored by Ocular Therapeutix.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of Ocular Treatment Emergent Adverse Events (TEAEs) and Non-ocular Treatment Emergent Adverse Events (TEAEs)
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 |
What the finished NCT04539548 record still lists
NCT04539548 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 228-participant average among 83 other Cataract trials with a reported enrollment target (71% lower).
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 lists 14 locations in 12 states (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.
Where NCT04539548's enrollment target sits among peer trials
65 50th of 83 higher than 33 of 83 other Cataract trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cataract 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
-
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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03366116 · 65 participants · Phase 1
5-aza-4'-Thio-2'-Deoxycytidine (Aza-TdC) in People With Advanced Solid Tumors
- NCT03603730 · 65 participants · NA
Vagal Nerve Stimulation for Functional Dyspepsia and Gastroparesis
- NCT03796559 · 65 participants · NA
Magseed Enabled Long-Term Localization of Axillary Lymph Nodes
- NCT03993106 · 65 participants · Phase 2
A Study of sEphB4-HSA in Kaposi Sarcoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI