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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: Completed Phase 3 study of Dry Eye Disease, sponsored by Dompé Farmaceutici S.p.A.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

The Schirmer test was used in ophthalmic examination to measure tear production for the diagnosis of conditions such as keratoconjunctivitis sicca and dry eye. Without previously instilling anesthetic drops, the Schirmer strip was inserted into the lower conjunctival sac at the junction of the lateral and middle thirds, avoiding touching the cornea, and the length of wetting strips in millimeters was recorded after 5 minutes. After 5 minutes had elapsed, the Schirmer's test strip was removed a

Conditions Studied

Dry Eye Disease

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

FieldValue
Enrollment Target 85 participants
Start Date 2022-01-27
Est. Completion 2023-05-24
Phase Phase 3
Dompé Farmaceutici S.p.A

27 total trials

What the finished NCT05136170 record still lists

NCT05136170 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 252-participant average among 33 other Dry Eye Disease trials with a reported enrollment target (66% lower).

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 lists 10 locations in 7 states (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.

Learn More About Clinical Trials

Similar trials for Dry Eye Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05136170's enrollment target sits among peer trials

85 25th of 33 higher than 9 of 33 other Dry Eye Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Dry Eye Disease 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT05136170, the US trial registry maintained by the National Library of Medicine. NCT05136170 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.