Last reviewed · How we verify
NCT02946125
A Single-Center, Open-Label, Observer-Masked, Active-Controlled, Phase 2 Study of the Safety, Efficacy and Pharmacokinetics of EYN-1601 in Dilation of the Pupil
Phase 2 trial testing MDD-administered EYN-1601 in Mydriasis in 12 participants. Completed in 1 November 2016.
1 November 2016
Quick facts
| Lead sponsor | Eyenovia Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 1 October 2016 |
| Primary completion | 1 November 2016 |
| Estimated completion | 1 November 2016 |
| Sites | 1 location across United States |
Drugs / interventions tested
- MDD-administered EYN-1601
- Phenylephrine 2.5% Eyedrop — full drug profile →
- Phenylephrine 10% Eyedrop — full drug profile →
Conditions studied
- Mydriasis — all drugs for Mydriasis →
Sponsor
Eyenovia Inc. — full company profile →
Who can join
18 and older, any sex, with Mydriasis. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Pupil Dilation
Time frame: 15, 30, 45, 60, 75, 120 and 180 minutes post administration of study drug
Mean change in pupil diameter from baseline (prior to study drug administration)
Sponsor's own description
This is a Phase 2 study to investigate the safety, efficacy and pharmacokinetics of EYN-1601 for dilation of the pupil. A single microdose of EYN-1601 will be compared to single doses of commercially available phenylephrine hydrochloride 2.5% and 10% ophthalmic solutions.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02946125
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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
- NCT03942419 — Microdosed Atropine 0.1% and 0.01% Ophthalmic Solutions for Reduction of Pediatric Myopia Progression · Phase 3 · 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 NCT02946125 (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 Eyenovia Inc.
- Last refreshed: 25 July 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/NCT02946125.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing