CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 104 enrolled
Drug / intervention
Oxervate +1 moredrug
Likely dose
Oxervate 20 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05133180
NCT05133180Phase 3Completed
CompareCT.gov

A 4-week, Phase III, Multicenter, Double-masked, Vehicle-controlled Clinical Study to Evaluate Safety and Efficacy of Oxervate® (Cenegermin) 20 mcg/mL Ophthalmic Solution vs Vehicle in Severe Sjogren's Dry Eye Disease

Dompé Farmaceutici S.p.A·interventional·Posted Nov 24, 2021·Updated Jun 7, 2024

In Brief

A Phase 3 clinical trial evaluating Oxervate and Vehicle for Dry Eye. Completed, enrolled 104 participants across 10 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye
CountriesItaly, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedNov 24, 2021
Enrollment StartJan 19, 2022
Primary CompletionSep 22, 2022
Study CompletionDec 19, 2022
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 4.6 years ago

Interventions

Oxervatedrug

Oxervate®, an ophthalmic solution containing cenegermin 20 mcg/mL, which is a recombinant human Nerve Growth Factor (rhNGF); one drop of the test product will be instilled in both eyes three times daily (TID).

Vehicleother

Vehicle will be instilled with the same scheme of the test product