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NCT02250612: SYLTAG
A Phase II, Observer Masked, Active Controlled Study of SYL040012 for the Treatment of Elevated Intraocular Pressure in Patients With Open-angle Glaucoma or Ocular Hypertension
Phase 2 trial testing 1 drop of 0.375% SYL040012 (bamosiran) in Open Angle Glaucoma in 184 participants. Completed in 1 January 2016.
1 August 2015
Quick facts
| Lead sponsor | Sylentis, S.A. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 184 |
| Start date | 1 October 2014 |
| Primary completion | 1 August 2015 |
| Estimated completion | 1 January 2016 |
| Sites | 21 locations across United States, Estonia, Germany, Spain |
Drugs / interventions tested
- 1 drop of 0.375% SYL040012 (bamosiran) — full drug profile →
- 1 drop of 0.750% SYL040012 (bamosiran) — full drug profile →
- 1 drop of 1.125% SYL040012 (bamosiran) — full drug profile →
- 1 drop of 1.5% SYL040012 (bamosiran) — full drug profile →
- 1 drop of 0.5 % timolol maleate — full drug profile →
Conditions studied
- Open Angle Glaucoma — all drugs for Open Angle Glaucoma →
- Ocular Hypertension — all drugs for Ocular Hypertension →
Sponsor
Sylentis, S.A. — full company profile →
Who can join
18 and older, any sex, with Open Angle 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.
-
Change From Baseline in the Mean Diurnal IOP Within Each Treatment Arm
Time frame: Baseline and Day 28
Sponsor's own description
The purpose of this double-masked, randomized, controlled study is to assess the safety and ocular hypotensive efficacy of four different doses of SYL040012 (bamosiran) eye drops compared to Timolol maleate 0.5% after 28 treatment days in patients with elevated intraocular pressure.
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 -
Advances in the delivery of RNA therapeutics: from concept to clinical reality.
Kaczmarek JC, Kowalski PS, Anderson DG. · · 2017 · cited 467× · PMID 28655327 · DOI 10.1186/s13073-017-0450-0 -
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 -
Therapeutic siRNA: State-of-the-Art and Future Perspectives.
Friedrich M, Aigner A. · · 2022 · cited 256× · PMID 35997897 · DOI 10.1007/s40259-022-00549-3 -
Paving the Road for RNA Therapeutics.
Dammes N, Peer D. · · 2020 · cited 159× · PMID 32893005 · DOI 10.1016/j.tips.2020.08.004 -
Therapeutic nucleic acids: current clinical status.
Sridharan K, Gogtay NJ. · · 2016 · cited 153× · PMID 27111518 · DOI 10.1111/bcp.12987 -
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 NCT02250612
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Open Angle Glaucoma
Currently open trials in the same condition.
- NCT07228221 — Standalone iStent Infinite and iDose TR for Management of Moderate to Severe Open Angle Glaucoma · Phase 4 · recruiting
- NCT06883123 — Efficacy of Simbrinza and Rocklatan vs Cosopt and Latanoprost · Phase 4 · recruiting
- NCT06666855 — A Phase III Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension in China · Phase 3 · active not recruiting
- NCT06246136 — Comparative Effectiveness and Safety of ELIOS in Patients With Open-Angle Glaucoma Undergoing Cataract Surgery · NA · recruiting
- NCT06061718 — Travoprost Intraocular Implant in Conjunction With Cataract Surgery · Phase 3 · active not 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 NCT02250612 (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: 11 December 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/NCT02250612.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing