# Safety and Efficacy Study on Cenegermin (Oxervate®) vs Vehicle in Severe Sjogren's Dry Eye Disease (PROTEGO-1 Study)

> **NCT05133180** · PHASE3 · COMPLETED · sponsor: **Dompé Farmaceutici S.p.A** · enrollment: 104 (actual)

## Conditions studied

- Dry Eye

## Interventions

- **DRUG:** Oxervate
- **OTHER:** Vehicle

## Key facts

- **NCT ID:** NCT05133180
- **Lead sponsor:** Dompé Farmaceutici S.p.A
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2022-01-19
- **Primary completion:** 2022-09-22
- **Final completion:** 2022-12-19
- **Target enrollment:** 104 (ACTUAL)
- **Last updated:** 2024-06-07


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05133180

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05133180, "Safety and Efficacy Study on Cenegermin (Oxervate®) vs Vehicle in Severe Sjogren's Dry Eye Disease (PROTEGO-1 Study)". Retrieved via AI Analytics 2026-06-05 from https://api.ai-analytics.org/clinical/NCT05133180. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*