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NCT00990743
Phase I Study With SYL040012. Tolerance and Effect on Intraocular Pressure
Phase 1 trial testing SYL040012 in Ocular Hypertension in 30 participants. Completed in 1 June 2010.
1 June 2010
Quick facts
| Lead sponsor | Sylentis, S.A. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 September 2009 |
| Primary completion | 1 June 2010 |
| Estimated completion | 1 June 2010 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- SYL040012 — full drug profile →
Conditions studied
- Ocular Hypertension — all drugs for Ocular Hypertension →
- Glaucoma — all drugs for Glaucoma →
Sponsor
Sylentis, S.A. — full company profile →
Who can join
Adults 18 to 45, any sex, with Ocular Hypertension or Glaucoma. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
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Part I: Local tolerance after administration of one dose of SYL040012.
Time frame: Part I: 3 days -
Part II: Local tolerance after 7 days administration of SYL040012 with one dose per day.
Time frame: Part II: 11 days
Sponsor's own description
The purpose of this study is to determine whether SYL040012 is safe for the treatment of ocular hypertension and glaucoma.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Noncoding RNA therapeutics - challenges and potential solutions.
Winkle M, El-Daly SM, Fabbri M, Calin GA. · · 2021 · cited 1123× · PMID 34145432 · DOI 10.1038/s41573-021-00219-z -
Therapeutic siRNA: state of the art.
Hu B, Zhong L, Weng Y, Peng L, et al · · 2020 · cited 991× · PMID 32561705 · DOI 10.1038/s41392-020-0207-x -
RNA-based therapeutics: current progress and future prospects.
Burnett JC, Rossi JJ. · · 2012 · cited 648× · PMID 22284355 · DOI 10.1016/j.chembiol.2011.12.008 -
Preclinical and clinical development of siRNA-based therapeutics.
Ozcan G, Ozpolat B, Coleman RL, Sood AK, et al · · 2015 · cited 331× · PMID 25666164 · DOI 10.1016/j.addr.2015.01.007 -
Current progress of siRNA/shRNA therapeutics in clinical trials.
Burnett JC, Rossi JJ, Tiemann K. · · 2011 · cited 313× · PMID 21744502 · DOI 10.1002/biot.201100054 -
Nanotoxicity: a key obstacle to clinical translation of siRNA-based nanomedicine.
Xue HY, Liu S, Wong HL. · · 2014 · cited 179× · PMID 24552562 · DOI 10.2217/nnm.13.204 -
Progress toward in vivo use of siRNAs-II.
Rettig GR, Behlke MA. · · 2012 · cited 163× · PMID 22186795 · DOI 10.1038/mt.2011.263 -
The landscape of nanoparticle-based siRNA delivery and therapeutic development.
Moazzam M, Zhang M, Hussain A, Yu X, et al · · 2024 · cited 116× · PMID 38204162 · DOI 10.1016/j.ymthe.2024.01.005
Verify or expand the search:
- PubMed search for NCT00990743
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Ocular Hypertension
Currently open trials in the same condition.
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- NCT07217678 — Biomarkers of Ocular Surface Damage in the Setting of Topical Ocular Hypotensive Medication Use · Phase 4 · recruiting
- NCT07218796 — Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compar · Phase 3 · recruiting
- NCT06629649 — Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers · NA · recruiting
- NCT07218783 — Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compar · Phase 3 · recruiting
Other Sylentis, S.A. trials
Trials by the same sponsor.
- NCT05637255 — A Randomized, Double Masked, Parallel Group, Dose-finding Study to Evaluate SYL1801 in Patients With Neovascular Age-rel · Phase 2 · completed
- NCT05310422 — Safety Study of Tivanisiran to Treat Dry Eye · Phase 3 · completed
- NCT04819269 — Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome · Phase 3 · completed
- NCT04782271 — Safety, Tolerability and Pharmacokinetic Profile of SYL1801 Eye Drops · Phase 1 · completed
- NCT03108664 — HELIX, a Double-masked Study of SYL1001 in Patients With Moderate to Severe Dry Eye Disease (DED) · 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 NCT00990743 (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 Sylentis, S.A.
- Last refreshed: 21 October 2010
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/NCT00990743.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing