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NCT04945824
A Human Factors Study to Evaluate a Novel Intracanalicular Insertion Device in Healthy Subjects
EARLY_PHASE1 trial testing Dexamethasone Ophthalmic in Healthy in 2 participants. Terminated before completion.
1 November 2022
Quick facts
| Lead sponsor | Ocular Therapeutix, Inc. |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 2 |
| Start date | 1 June 2021 |
| Primary completion | 1 November 2022 |
| Estimated completion | 1 November 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Dexamethasone Ophthalmic
- Dilator
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Ocular Therapeutix, Inc. — full company profile →
Who can join
18 and older, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is an open-label, multi-center, bilateral, human factors study designed to evaluate the utilization and safety of a novel intracanalicular insertion device in healthy subjects and to evaluate the concentration of DEXTENZA in tears. Each subject's participation is expected to last for approximately 1 month from the DEXTENZA insertion.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04945824
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Ocular Therapeutix, Inc. trials
Trials by the same sponsor.
- NCT07516132 — Study to Evaluate Long-Term Safety of Intravitreal OTX-TKI (Axitinib Implant) in Participants With Neovascular Age-Relat · Phase 3 · not yet recruiting
- NCT06495918 — Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- R · Phase 3 · active not recruiting
- NCT06223958 — Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Ocular Therapeutix) (Axitinib Implant) in Subjects Wi · Phase 3 · active not recruiting
- NCT05814757 — OTX-DED for the Short-term Treatment of the Symptoms of Dry Eye Disease (DED) · Phase 2 · completed
- NCT05335122 — A Study to Evaluate the Efficacy and Safety of OTX-TIC (Travoprost) Intracameral Implant for Patients With Open-angle Gl · Phase 2 · completed
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 NCT04945824 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ocular Therapeutix, Inc.
- Last refreshed: 6 February 2023
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/NCT04945824.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing