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NCT02420730
Safety, Tolerability and Systemic Pharmacokinetics of AGN-232411 in Healthy Participants and Participants With Dry Eye
Phase 1 trial testing AGN-232411 in Healthy Volunteers in 77 participants. Completed in 1 March 2016.
1 March 2016
Quick facts
| Lead sponsor | Allergan |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 77 |
| Start date | 1 June 2015 |
| Primary completion | 1 March 2016 |
| Estimated completion | 1 March 2016 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- AGN-232411 — full drug profile →
- AGN-232411 Vehicle — full drug profile →
Conditions studied
- Healthy Volunteers — all drugs for Healthy Volunteers →
- Dry Eye Syndromes — all drugs for Dry Eye Syndromes →
Sponsor
Allergan — full company profile →
Who can join
18 and older, any sex, with Healthy Volunteers or Dry Eye Syndromes. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 56 days
Sponsor's own description
This study will examine the safety, tolerability, and systemic pharmacokinetics of up to 3 different concentrations of AGN-232411 topical ophthalmic solution in healthy participants and participants with dry eye.
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 NCT02420730
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT02420730 (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 Allergan
- Last refreshed: 13 July 2016
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/NCT02420730.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing