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NCT04701086: PROSIKA
3 Month Study of Cationorm Pro Versus Vismed in Adults With Dry Eye Disease Related to Keratitis or Keratoconjunctivitis
NA trial testing Cationorm Pro in Dry Eye Syndromes in 83 participants. Completed in 28 April 2025.
28 April 2025
Quick facts
| Lead sponsor | Santen SAS |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 83 |
| Start date | 30 September 2021 |
| Primary completion | 28 April 2025 |
| Estimated completion | 28 April 2025 |
| Sites | 8 locations across France, Spain, Poland |
Drugs / interventions tested
- Cationorm Pro
- Vismed
Conditions studied
- Dry Eye Syndromes — all drugs for Dry Eye Syndromes →
Sponsor
Santen SAS — full company profile →
Who can join
18 and older, any sex, with Dry Eye Syndromes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is a prospective, multicentre, parallel-group, active-controlled, non-inferiority study conducted in adult patients with moderate-to-severe dry eye disease (DED) related to keratitis or keratoconjunctivitis. This study is to be conducted in France, Poland and Spain. The patients will be randomised to receive Cationorm Pro® or the reference treatment, VISMED® (ratio 1:1) in an investigator-masked fashion
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 NCT04701086
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Dry Eye Syndromes
Currently open trials in the same condition.
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- NCT06913504 — Comparison Of Blue Light Filter Feature and Blue Blocking Lenses in Digital Device Users With Dry Eye Patients · NA · active not recruiting
- NCT06913465 — The Impact of Hypothyroidism on Tear Production and Dry Eye Symptoms: Implications for Optometric Care · active not recruiting
- NCT06831253 — Efficacy of Platelet-Rich Plasma Injection in Dry Eye Syndrome · NA · recruiting
- NCT06220474 — Therapeutic Efficacy and Safety of Non-Invasive RF Treatment in Refractory MGD · NA · recruiting
Other Santen SAS trials
Trials by the same sponsor.
- NCT06514612 — LIDRISE Study: A Phase 3 Study on the Efficacy and Safety of STN1013800 (Oxymetazoline HCl 0.1% Eye Drops, Single Dose) · Phase 3 · recruiting
- NCT04685109 — 3 Month Study of Alocross Versus Vismed in Adults With Dry Eye Disease Related to Keratitis or Keratoconjunctivitis · NA · active not recruiting
- NCT04144413 — 3-year Study in Dry Eye Disease Patients With Severe Keratitis Receiving Ikervis® (1mg/mL Ciclosporin) · Phase 3 · completed
- NCT04133311 — A Phase III Multinational Multicenter Investigator-Masked Randomized Active-Controlled Trial Comparing the Efficacy and · Phase 3 · completed
- NCT03237936 — Effect of IKERVIS® Eye Drops Once Daily on the Quality of Vision in Dry Eye Disease Patients With Severe Keratitis · Phase 4 · 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 NCT04701086 (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 Santen SAS
- Last refreshed: 21 May 2025
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/NCT04701086.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing