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NCT03293992
A Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7058584 Following 7 Days of Instillation of Eye Drops in Patients With Primary Open Angle Glaucoma or Ocular Hypertension
Phase 1 trial testing 0.01% RO7058584 in Glaucoma, Open-angle in 27 participants. Completed in 21 December 2017.
15 December 2017
Quick facts
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 27 |
| Start date | 10 October 2017 |
| Primary completion | 15 December 2017 |
| Estimated completion | 21 December 2017 |
| Sites | 8 locations across United States |
Drugs / interventions tested
- 0.01% RO7058584 — full drug profile →
- 0.1% RO7058584 — full drug profile →
- 1% RO7058584 — full drug profile →
- Matching Placebo — full drug profile →
- Latanoprost 0.005% — full drug profile →
Conditions studied
- Glaucoma, Open-angle — all drugs for Glaucoma, Open-angle →
- Ocular Hypertension — all drugs for Ocular Hypertension →
Sponsor
Hoffmann-La Roche — full company profile →
Who can join
Adults 18 to 90, any sex, with Glaucoma, Open-angle or Ocular Hypertension. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Phase I, multi-center, randomized, adaptive, investigator/patient-masked, placebo-controlled, parallel multiple-ascending dose study (Part A) with an extension including up to two selected doses from Part A and latanoprost 0.005% as active comparator (Part B).
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 NCT03293992
- 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 NCT03293992 (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 Hoffmann-La Roche
- Last refreshed: 31 March 2020
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/NCT03293992.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing