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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: Completed Phase 3 study of Dry Eye, sponsored by Dompé Farmaceutici S.p.A.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Schirmer test type I (without anaesthesia) was performed to measure aqueous tear secretion. The rounded bend end of a sterile strip was inserted into the lower conjunctival sac over the temporal one-third of the lower eyelid margin. After 5 minutes had elapsed, the Schirmer's test strip was removed and the length of the tear absorption on the strip was measured (millimeters/5 minutes). The longer the wetted length, the healthier the status of the eye.
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 |
What the finished NCT05133180 record still lists
NCT05133180 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, above the 93-participant average among 41 other Dry Eye trials with a reported enrollment target (12% higher).
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 lists 10 locations in 6 states (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.
Learn More About Clinical Trials
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Where NCT05133180's enrollment target sits among peer trials
104 10th of 41 higher than 31 of 41 other Dry Eye trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dry Eye trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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