Assessment of Both Systemic and Ocular Adverse Events
Primary
· 10 weeks
Number of patients experiencing Adverse Events during the study
| Group | Value | 95% CI |
|---|---|---|
| TRS01 Low Dose | 2 | |
| TRS01 High Dose | 5 |
Last reviewed · How we verify
NCT04222712
A Study to Evaluate TRS01 Eye Drops in Participants With Active Non-infectious Anterior Uveitis
Completed
Phase 1, PHASE2
Results posted
Last updated 5 October 2023
What this trial tests
Phase 1, PHASE2 trial testing TRS01 eye drops in Non-infectious Anterior Uveitis in 16 participants. Completed in 24 August 2020.
Timeline
1 February 2020
Primary endpoint
24 August 2020
24 August 2020
24 August 2020
Quick facts
| Lead sponsor | Tarsier Pharma |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 16 |
| Start date | 1 February 2020 |
| Primary completion | 24 August 2020 |
| Estimated completion | 24 August 2020 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- TRS01 eye drops — full drug profile →
- TRS01 eye drops — full drug profile →
Conditions studied
- Non-infectious Anterior Uveitis — all drugs for Non-infectious Anterior Uveitis →
Sponsor
Tarsier Pharma — full company profile →
Who can join
18 and older, any sex, with Non-infectious Anterior Uveitis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Adverse events — posted to ClinicalTrials.gov
Time frame: 10 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
TRS01 Low Dose
Serious: 0/8 (0%)
Deaths: 0/8
TRS01 High Dose
Serious: 0/8 (0%)
Deaths: 0/8
Other adverse events (16 terms — click to expand)
| Reaction | System | TRS01 Low Dose | TRS01 High Dose |
|---|---|---|---|
| Anxiety | Psychiatric disorders | — | — |
| Arthropod bite | Injury, poisoning and procedural complications | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Instillation site pain | General disorders | — | — |
| Fatigue | General disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Iritis | Eye disorders | — | — |
| Gastric ulcer | Gastrointestinal disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Psoriasis | Skin and subcutaneous tissue disorders | — | — |
| Hordeolum | Infections and infestations | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Syphilis | Infections and infestations | — | — |
| Vitamin D deficiency | Metabolism and nutrition disorders | — | — |
| Muscle strain | Injury, poisoning and procedural complications | — | — |
Data from ClinicalTrials.gov NCT04222712 adverse events section.
Sponsor's own description
The objective of this study is to evaluate the safety of TRS01 eye drops in participants with active non-infectious anterior uveitis .
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 NCT04222712
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of TRS01 eye drops
Trials testing the same drug.
- NCT04222725 — A Study of TRS01 in Participants With Post-surgical Ocular Inflammation · Phase 1, PHASE2 · completed
Other Tarsier Pharma trials
Trials by the same sponsor.
- NCT05042609 — A Study of TRS01 in Subjects With Active Non-infectious Anterior Uveitis Including Subjects With Uveitic Glaucoma · Phase 3 · completed
- NCT04222725 — A Study of TRS01 in Participants With Post-surgical Ocular Inflammation · Phase 1, PHASE2 · 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 NCT04222712 (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 Tarsier Pharma
- Last refreshed: 5 October 2023
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/NCT04222712.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing