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NCT06291194
The Purpose of This Clinical Study is to Prove That the Test Drug (AJU-S56 5%) is Superior to the Control Drug After 24 Weeks of Administration to Patients Who Have Moderate or Severe Dry Eye Syndrome
Phase 3 trial testing AJU-S56 5% in Dry Eye Syndromes in 396 participants. Status unknown.
1 May 2024
Quick facts
| Lead sponsor | AJU Pharm Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 396 |
| Start date | 10 November 2023 |
| Primary completion | 1 May 2024 |
| Estimated completion | 1 May 2024 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- AJU-S56 5% — full drug profile →
- Placebo Group(Vehicle) — full drug profile →
Conditions studied
- Dry Eye Syndromes — all drugs for Dry Eye Syndromes →
Sponsor
AJU Pharm Co., Ltd. — full company profile →
Who can join
19 and older, any sex, with Dry Eye Syndromes. 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.
-
Total corneal staining score (TCSS)
Time frame: WEEK 4, 8, 12
TCSS ≥4 at baseline (Total Max score : 15)
Sponsor's own description
This study is planned to Evaluate the Efficacy and Safety of test drug (AJU-S56 5%) compared to control drug(vehicle) in Patients with Dry Eye Disease.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06291194
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of AJU-S56 5%
Trials testing the same drug.
- NCT06337981 — Efficacy and Safety of AJU-S56 in Dry Eye Syndrome Patients · Phase 2 · completed
Other recruiting trials for Dry Eye Syndromes
Currently open trials in the same condition.
- NCT07412860 — Clinical Investigation Between the Topical Administration of a Tear Substitute With Ancillary Medicinal Substance and Hy · NA · recruiting
- 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 AJU Pharm Co., Ltd. trials
Trials by the same sponsor.
- NCT06933459 — To Evaluate the Safety and Pharmacokinetic Characteristics of AJU-C714 and C714R in Healthy Adults · Phase 1 · active not recruiting
- NCT06931327 — To Evaluate the Safety and Pharmacokinetic Characteristics of AJU-C711 in Healthy Adults · Phase 1 · completed
- NCT06345014 — The Efficacy and Safety of OM-89 in Patients With Recurrent Chronic Prostatitis/Chronic Pelvic Pain Syndrome · Phase 4 · recruiting
- NCT06416865 — Efficacy and Safety of AJU-C52 in Essential Hypertension Patients · Phase 3 · recruiting
- NCT07230184 — To Evaluate the Efficacy and Safety of Combination Therapy With B55R1 and B55R2 Compared to B55R1 Monotherapy in Patient · 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 NCT06291194 (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 AJU Pharm Co., Ltd.
- Last refreshed: 4 April 2024
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/NCT06291194.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing