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NCT05136170 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate Safety and Efficacy of Cenegermin (Oxervate®) vs Vehicle in Severe Sjogren's Dry Eye Disease
A Phase 3 study of Dry Eye Disease, sponsored by Dompé Farmaceutici S.p.A.
- Completed
- Registry status
- Phase 3
- Development phase
- 85
- Enrollment target
- 10
- Study locations
NCT05136170 is a Phase 3 study of Dry Eye Disease that has completed, run by Dompé Farmaceutici S.p.A. The registered enrollment target is 85 participants, below the 252-participant average among 33 other Dry Eye Disease trials with a reported enrollment target (66% lower). The trial reports 10 study locations across 7 states.
The verdict
NCT05136170, a Phase 3 study of Dry Eye Disease, has completed, sponsored by Dompé Farmaceutici S.p.A.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 85 participants
- Enrollment target
- 10
- Study locations
Study Summary
Primary Objectives: * To compare the efficacy of cenegermin vs vehicle in Schirmer I test (without anaesthesia) \> 10 mm/5 min 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 Cenegermin
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
Tennessee
- Houston Eye Associates HEA - Gramercy Location - Houston
- Toyos Clinic - Nashville - Nashville
California
- Lugene Eye Institute - Glendale Office - Glendale
Maryland
- The Johns Hopkins University - Baltimore
Massachusetts
- Tufts University School of Medicine (TUSM) - New England Eye Center/Tufts Medical Center - Boston
New York
- OCLI (Ophthalmic Consultants of Long Island) - Garden City
Pennsylvania
- Scheie Eye Institute - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2022-01-27 |
| Est. Completion | 2023-05-24 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05136170
The ClinicalTrials.gov registry entry for NCT05136170 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 85 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 252-participant average among 33 other Dry Eye Disease trials with a reported enrollment target (66% lower). 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 Disease appearing as the primary indexed condition, and to 2 interventions - of which Vehicle is the first listed.
NCT05136170 reports 10 study locations spanning 7 distinct geographic areas - top geographies include Other, Tennessee, California.
Frequently Asked Questions
What is clinical trial NCT05136170 about?
NCT05136170 is a clinical study titled "Study to Evaluate Safety and Efficacy of Cenegermin (Oxervate®) vs Vehicle in Severe Sjogren's Dry Eye Disease". Primary Objectives: * To compare the efficacy of cenegermin vs vehicle in Schirmer I test (without anaesthesia) \> 10 mm/5 min 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 t...
What is the current status of trial NCT05136170?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 85 participants. The study started on 2022-01-27. Estimated completion is 2023-05-24.
What conditions does trial NCT05136170 study?
This clinical trial studies the following conditions: Dry Eye Disease.
What interventions are being tested in trial NCT05136170?
The interventions under investigation include: Vehicle (OTHER), Cenegermin (DRUG).
Who is sponsoring clinical trial NCT05136170?
This trial is sponsored by Dompé Farmaceutici S.p.A, which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05136170 being conducted?
This trial has 10 study locations across California, Maryland, Massachusetts, New York, Pennsylvania. 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.
Related
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