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NCT05133180 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study on Cenegermin (Oxervate®) vs Vehicle in Severe Sjogren's Dry Eye Disease (PROTEGO-1 Study)
A Phase 3 study of Dry Eye, sponsored by Dompé Farmaceutici S.p.A.
- Completed
- Registry status
- Phase 3
- Development phase
- 104
- Enrollment target
- 10
- Study locations
NCT05133180 is a Phase 3 study of Dry Eye that has completed, run by Dompé Farmaceutici S.p.A. The registered enrollment target is 104 participants, above the 93-participant average among 41 other Dry Eye trials with a reported enrollment target (12% higher). The trial reports 10 study locations across 6 states.
The verdict
NCT05133180, a Phase 3 study of Dry Eye, has completed, sponsored by Dompé Farmaceutici S.p.A.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 104 participants
- Enrollment target
- 10
- Study locations
Study Summary
Primary objectives * To compare the efficacy of cenegermin vs vehicle in Schirmer I test (without anaesthesia) \>10mm/5min at Week 4 by testing the superiority. * To compare the efficacy of cenegermin vs vehicle in Symptom Assessment in Dry Eye questionnaire (SANDE) global score at Week 12 by testing the superiority. Secondary objectives * To compare the efficacy of cenegermin vs vehicle in Schirmer I test at Week 4, 8, 12 and 16 by testing the superiority. * To compare the efficacy of cenegermin vs vehicle in Cornea and conjunctiva vital staining with fluorescein (National Eye Institute \[NEI\] scales) at Week 4, 8, 12 and 16 by testing the superiority. * To compare the efficacy of cenegermin vs vehicle in Tear Film Break-Up Time (TFBUT) at Week 4, 8, 12 and 16 by testing the superiority. * To compare the efficacy of cenegermin vs vehicle in SANDE scores at Week 8, 12 and 16 by testing the superiority. * To compare the efficacy of cenegermin vs vehicle in worsening in symptom scores (SANDE) and/or NEI score at Week 4 by testing the superiority. * To compare the efficacy of cenegermin vs vehicle in impact of dry eye on everyday life (IDEEL) questionnaire at Week 4, 8, 12 and 16 by testing the superiority.
Conditions Studied
Interventions
- OTHER Vehicle
- DRUG Oxervate
Study Locations (10)
Other
- AOU Gaspare Rodolico - Ospedale San Marco - Catania
- Università degli Studi di Milano - Ospedale San Giuseppe - UO Oculistica - Milan
- AOU Policlinico Umberto I - Dipartimento Organi di Senso - Clinica Oculistica - Roma
California
- Lugene Eye Institute - Glendale Office - Glendale
- David Wirta, M.D. & Associates - Newport Beach
Tennessee
- Houston Eye Associates HEA - Gramercy Location - Houston
- Toyos Clinic - Nashville - Nashville
Maryland
- The Johns Hopkins University - Baltimore
Massachusetts
- Tufts University School of Medicine (TUSM) - New England Eye Center/Tufts Medical Center - Boston - Boston
Virginia
- Virginia Eye Consultants (VEC) - Norfolk Office - Norfolk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2022-01-19 |
| Est. Completion | 2022-12-19 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05133180
The ClinicalTrials.gov registry entry for NCT05133180 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 93-participant average among 41 other Dry Eye trials with a reported enrollment target (12% higher). The listed sponsor is Dompé Farmaceutici S.p.A, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Dry Eye appearing as the primary indexed condition, and to 2 interventions - of which Vehicle is the first listed.
NCT05133180 reports 10 study locations spanning 6 distinct geographic areas - top geographies include Other, California, Tennessee.
Frequently Asked Questions
What is clinical trial NCT05133180 about?
NCT05133180 is a clinical study titled "Safety and Efficacy Study on Cenegermin (Oxervate®) vs Vehicle in Severe Sjogren's Dry Eye Disease (PROTEGO-1 Study)". Primary objectives * To compare the efficacy of cenegermin vs vehicle in Schirmer I test (without anaesthesia) \>10mm/5min at Week 4 by testing the superiority. * To compare the efficacy of cenegermin vs vehicle in Symptom Assessment in Dry Eye questionnaire (SANDE) global score at Week 12 by testi...
What is the current status of trial NCT05133180?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 104 participants. The study started on 2022-01-19. Estimated completion is 2022-12-19.
What conditions does trial NCT05133180 study?
This clinical trial studies the following conditions: Dry Eye.
What interventions are being tested in trial NCT05133180?
The interventions under investigation include: Vehicle (OTHER), Oxervate (DRUG).
Who is sponsoring clinical trial NCT05133180?
This trial is sponsored by Dompé Farmaceutici S.p.A, which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05133180 being conducted?
This trial has 10 study locations across California, Maryland, Massachusetts, Tennessee, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
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