Last reviewed · How we verify
NCT04549935
The PRIME Study: A Randomized, Controlled, Prospective Study
Phase 4 trial testing Dextenza in Patient Preference in 20 participants. Currently enrolling.
27 August 2021
Quick facts
| Lead sponsor | Vance Thompson Vision - MT |
|---|---|
| Phase | Phase 4 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 14 September 2020 |
| Primary completion | 27 August 2021 |
| Estimated completion | 27 August 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Dextenza — full drug profile →
- Topical Prednisolone — full drug profile →
Conditions studied
- Patient Preference — all drugs for Patient Preference →
- Patient Outcomes — all drugs for Patient Outcomes →
- Post-Operative Inflammation — all drugs for Post-Operative Inflammation →
- Grade of Post-Operative Cystoid Macular Edema — all drugs for Grade of Post-Operative Cystoid Macular Edema →
Sponsor
Vance Thompson Vision - MT — full company profile →
Who can join
Adults 22 to 75, any sex, with Patient Preference or Patient Outcomes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To investigate the outcomes of patients undergoing bilateral RLE surgery with treatment of dexamethasone intracanilicular insert compared to topical standard care steroid. Desiged to look at patient preference comparing the insert to drops and will also look at patient outcomes including inflammatin and risk of cystoid macular edema post-operatively.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Deep learning for the prediction of early on-treatment response in metastatic colorectal cancer from serial medical imaging.
Lu L, Dercle L, Zhao B, Schwartz LH. · · 2021 · cited 72× · PMID 34789774 · DOI 10.1038/s41467-021-26990-6
Verify or expand the search:
- PubMed search for NCT04549935
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Dextenza
Trials testing the same drug.
- NCT04464629 — Assessing the Efficacy and Safety of DEXTENZA in Pseudo Phakic Patients Undergoing Gas Bubble Repair and Laser Following · Phase 4 · terminated
- NCT04168112 — Intracanalicular Dexamethasone Insert for Post-Corneal Cross-Linking Inflammation and Pain- The LINK Study · Phase 4 · completed
Other recruiting trials for Patient Preference
Currently open trials in the same condition.
- NCT06508697 — CT-Angiography Plaque Characteristics and Events in Deferral Patients by Invasive Fractional Flow Reserve · recruiting
- NCT06240260 — TENS Unit for Analgesia During IUD Insertion · NA · recruiting
- NCT06376799 — Which Health-care Professional(s) to Talk About Advance Care Planning ? · recruiting
- NCT06002113 — Eliciting Informed Goals of Care in Elderly Patients · NA · recruiting
- NCT04205916 — A Trial Evaluating Patient Preference of Dropless vs Drops Post Cataract Surgery · Phase 4 · recruiting
Other Vance Thompson Vision - MT trials
Trials by the same sponsor.
- NCT05136924 — IIT Assessing OC-01Nasal Spray on Symptoms of DED Following CXL · Phase 2 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04549935 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Vance Thompson Vision - MT
- Last refreshed: 16 September 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04549935.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing