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NCT04413279
Lipiflow Treatment Alone vs. Lipiflow + Dextenza Treatment for Dry Eye Disease
Phase 4 trial testing LipiFlow Thermal Pulsation in Dry Eye Syndromes in 20 participants. Completed in 1 July 2021.
1 July 2021
Quick facts
| Lead sponsor | Eye Surgeons of Indiana |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 August 2020 |
| Primary completion | 1 July 2021 |
| Estimated completion | 1 July 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- LipiFlow Thermal Pulsation
- Dexamethasone Intracanalicular Insert, 0.4mg with LipiFlow Thermal Pulsation — full drug profile →
Conditions studied
- Dry Eye Syndromes — all drugs for Dry Eye Syndromes →
Sponsor
Eye Surgeons of Indiana — full company profile →
Who can join
Eligibility, any sex, with Dry Eye Syndromes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To evaluate the benefit of treatment with a physician administered intracanalicular dexamethasone insert in evaporative dry eye disease (DED) patients with meibomian gland disfunction (MGD) and underlying inflammation undergoing LipiFlow Thermal Pulsation.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Dry eye syndrome: comprehensive etiologies and recent clinical trials.
Huang R, Su C, Fang L, Lu J, et al · · 2022 · cited 52× · PMID 35678897 · DOI 10.1007/s10792-022-02320-7 -
Thermal Pulsation with or without Dexamethasone Intracanalicular Insert for Meibomian Gland Dysfunction: A Prospective, Masked Trial.
Dierker DS, Hauswirth SG. · · 2022 · cited 2× · PMID 35585875 · DOI 10.2147/opth.s359719
Verify or expand the search:
- PubMed search for NCT04413279
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Dry Eye Syndromes
Currently open trials in the same condition.
- NCT07412860 — Clinical Investigation Between the Topical Administration of a Tear Substitute With Ancillary Medicinal Substance and Hy · NA · recruiting
- NCT06913504 — Comparison Of Blue Light Filter Feature and Blue Blocking Lenses in Digital Device Users With Dry Eye Patients · NA · active not recruiting
- NCT06913465 — The Impact of Hypothyroidism on Tear Production and Dry Eye Symptoms: Implications for Optometric Care · active not recruiting
- NCT06831253 — Efficacy of Platelet-Rich Plasma Injection in Dry Eye Syndrome · NA · recruiting
- NCT06220474 — Therapeutic Efficacy and Safety of Non-Invasive RF Treatment in Refractory MGD · NA · recruiting
Other Eye Surgeons of Indiana trials
Trials by the same sponsor.
- NCT04413253 — Xiidra vs. Xiidra + Dextenza Treatment for Dry Eye Disease · Phase 4 · terminated
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 NCT04413279 (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 Eye Surgeons of Indiana
- Last refreshed: 18 April 2022
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/NCT04413279.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing