Last reviewed · How we verify
NCT03942419
Microdosed Atropine 0.1% and 0.01% Ophthalmic Solutions for Reduction of Pediatric Myopia Progression
Phase 3 trial testing Atropine 0.1% Ophthalmic Solution in Myopia in 438 participants. Terminated before completion.
31 October 2024
Quick facts
| Lead sponsor | Eyenovia Inc. |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 438 |
| Start date | 3 June 2019 |
| Primary completion | 31 October 2024 |
| Estimated completion | 20 November 2024 |
| Sites | 18 locations across United States |
Drugs / interventions tested
- Atropine 0.1% Ophthalmic Solution — full drug profile →
- Atropine 0.01% Ophthalmic Solution — full drug profile →
- Placebo Ophthalmic Solution — full drug profile →
Conditions studied
- Myopia — all drugs for Myopia →
Sponsor
Eyenovia Inc. — full company profile →
Who can join
Adults 3 to 12, any sex, with Myopia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study evaluates the progression of myopia in participants using microdosed atropine 0.01%, atropine 0.1%, or placebo ophthalmic solution. Eligible subjects will administer study medication daily in each eye for 48 months. Efficacy and safety assessments will be performed at visits scheduled for 1, 6, 12, 18, 24, 30 and 36 months after initiation of medication use. Subjects will be re-randomized at the 36 month visit, then followed at 6 month intervals for an additional year.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Interventions for myopia control in children: a living systematic review and network meta-analysis.
Lawrenson JG, Shah R, Huntjens B, Downie LE, et al · · 2023 · cited 117× · PMID 36809645 · DOI 10.1002/14651858.cd014758.pub2 -
Atropine 0.01% Eye Drops for Myopia Control in American Children: A Multiethnic Sample Across Three US Sites.
Larkin GL, Tahir A, Epley KD, Beauchamp CL, et al · · 2019 · cited 41× · PMID 31602553 · DOI 10.1007/s40123-019-00217-w
Verify or expand the search:
- PubMed search for NCT03942419
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Myopia
Currently open trials in the same condition.
- NCT07284966 — Comfort and Vision With TOTAL30 Multifocal Lenses · recruiting
- NCT07078799 — Wavefront-guided LASIK Surgery Compared to Ray Tracing-Guided LASIK Surgery · NA · recruiting
- NCT07585877 — Effect of Branched-Chain Amino Acid Supplementation on Myopia Progression · NA · active not recruiting
- NCT07354945 — An Evaluation of Myopia Control Lenses on Wearing Experience in Myopic Children · NA · recruiting
- NCT07229365 — Children's Viewing Behavior · NA · recruiting
Other Eyenovia Inc. trials
Trials by the same sponsor.
- NCT06217796 — Safety and Efficacy of Fixed Combination Phenylephrine-Tropicamide for Pupil Dilation · Phase 4 · completed
- NCT05114486 — Safety & Efficacy of Pilocarpine Ophthalmic Spray for Temporary Improvement of Near Vision in Presbyopic Adults · Phase 3 · completed
- NCT04907474 — Evaluation of Pupil Dilation Speed With the MAP Dispenser · Phase 4 · completed
- NCT04657172 — Safety & Efficacy of Pilocarpine Eye Solutions for Temporary Improvement of Near Vision in Presbyopic Adults · Phase 3 · completed
- NCT03751098 — Safety and Efficacy of Phenylephrine 2.5%-Tropicamide 1% Microdose Ophthalmic Solution for Pupil Dilation · Phase 3 · 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 NCT03942419 (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 Eyenovia Inc.
- Last refreshed: 6 January 2025
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/NCT03942419.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing