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NCT05321251
Topical Insulin Drops for the Treatment of Neurotrophic Keratopathy.
Phase 2, PHASE3 trial testing Insulin in Neurotrophic Keratitis. Withdrawn.
18 October 2023
Quick facts
| Lead sponsor | University of Alberta |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Start date | 1 June 2022 |
| Primary completion | 18 October 2023 |
| Estimated completion | 18 October 2023 |
| Sites | 6 locations across Canada |
Drugs / interventions tested
- Insulin (insulin) — full drug profile →
- Tarsorrhaphy
Conditions studied
- Neurotrophic Keratitis — all drugs for Neurotrophic Keratitis →
Sponsor
University of Alberta
Who can join
18 and older, any sex, with Neurotrophic Keratitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Many diseases can affect corneal nerves. Corneas that lack normal sensation are considered neurotrophic. Neurotrophic corneas are predisposed to persistent epithelial defects, recurrent erosions, and corneal ulcers. These can lead to a variety of complications, from subjective pain, discomfort, and blurry vision, to corneal perforation and endophthalmitis. Neurotrophic corneas and the persistent epithelial defects associated with them can be very difficult to treat. Non-invasive measures include topical drops (artificial tears, antibiotics, or steroids), bandage contact lens, and punctal plugs. More invasive surgical treatments include membrane grafts, tarsorrhaphy, and keratoplasty. Despite these treatments, many neurotrophic corneas still do not heal. This study aims to test the efficacy of topical insulin in the treatment of neurotrophic keratopathy.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Recent United States Developments in the Pharmacological Treatment of Dry Eye Disease.
Valdés-Arias D, Locatelli EVT, Sepulveda-Beltran PA, Mangwani-Mordani S, et al · · 2024 · cited 16× · PMID 38652355 · DOI 10.1007/s40265-024-02031-6
Verify or expand the search:
- PubMed search for NCT05321251
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Neurotrophic Keratitis
Currently open trials in the same condition.
- NCT06964269 — Use of Acthar Gel Single-Dose Pre-Filled SelfJectTM Injector in Patients With Moderate-Severe Keratitis and Autoimmune D · Phase 4 · recruiting
- NCT05927428 — Assessment of the Initial Efficacy and Safety of BRM424 Ophthalmic Solutions in Patients With Neurotrophic Keratitis · Phase 2 · recruiting
- NCT06947850 — DOMPE -MT Neurotrophic Keratitis · Phase 4 · active not recruiting
- NCT04573647 — OCT Evaluation of Neurotrophic Ulcer Following Treatment With Oxervate · recruiting
Other University of Alberta trials
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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 NCT05321251 (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 University of Alberta
- Last refreshed: 5 February 2024
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/NCT05321251.
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