NCT01227291 is a Phase 1/Phase 2 clinical trial of SYL040012 in Glaucoma, sponsored by Sylentis, S.A..

Who is sponsoring NCT01227291?

NCT01227291 is sponsored by Sylentis, S.A..

What drugs are being tested in NCT01227291?

Interventions in NCT01227291: SYL040012.

What condition does NCT01227291 study?

NCT01227291 studies Glaucoma, Ocular Hypertension.

Is NCT01227291 still recruiting?

NCT01227291 is currently completed. Last updated 26 September 2012.

Last reviewed 2012-09-26 · How we verify

NCT01227291

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study With SYL040012. Tolerance and Effect on Intraocular Pressure in Subjects With IOP >= 21 mm Hg.

Completed Phase 1/Phase 2 Last updated 26 September 2012

What this trial tests

Phase 1/Phase 2 trial testing SYL040012 in Glaucoma in 30 participants. Completed in 1 September 2012.

Timeline

1 October 2010

Primary endpoint
1 March 2012

1 September 2012

Quick facts

Lead sponsor	Sylentis, S.A.
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 October 2010
Primary completion	1 March 2012
Estimated completion	1 September 2012
Sites	2 locations across Spain

Drugs / interventions tested

SYL040012 — full drug profile →

Conditions studied

Glaucoma — all drugs for Glaucoma →
Ocular Hypertension — all drugs for Ocular Hypertension →

Sponsor

Sylentis, S.A. — full company profile →

Who can join

18 and older, any sex, with Glaucoma or Ocular Hypertension. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Tolerance on ocular surface (ocular and conjunctiva)
Time frame: 7 days + 24 hours
Local Tolerance and ocular surface(cornea and conjunctival) on the area of administration 24 hours after last administration of multiple dose during 7 days of administration. It will be performed using a slit lamp which will be performed before, during and after the administration at established times. Adverse events will be registered and the determination of subjective tolerance will use the vis

Sponsor's own description

The aim of this study is to evaluate the tolerance and effect on unmedicated subjects with elevated IOP.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

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
Therapeutic nucleic acids: current clinical status.
Sridharan K, Gogtay NJ. · · 2016 · cited 153× · PMID 27111518 · DOI 10.1111/bcp.12987

Verify or expand the search:

Other recruiting trials for Glaucoma

Currently open trials in the same condition.

NCT07455786 — Modified Trabeculectomy After Failure of Combined Phaco With GATT · NA · recruiting
NCT07298356 — Automated Applanation Tonometry - Updated · NA · recruiting
NCT07217678 — Biomarkers of Ocular Surface Damage in the Setting of Topical Ocular Hypotensive Medication Use · Phase 4 · recruiting
NCT07145073 — Repetitive Transcranial Alternating Current Stimulation (rtACS) for the Treatment of Optic Neuropathies · NA · recruiting
NCT07209410 — Evaluating Injection With the Use of Brimonidine Tartrate Ophthalmic 0.025% on Patients Using Netarsudil 0.02%/Latanopro · Phase 4 · 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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01227291 (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: 26 September 2012

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/NCT01227291.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing