CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 350 enrolled
Drug / intervention
Open-label Ikervis +2 moredrug
Likely dose
Open-label Ikervis 1mgfrom 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/NCT04144413
NCT04144413Phase 3Completed
CompareCT.gov

A Phase IIIb, Prospective, Interventional, Multicentre, 3-year Study to Explore the Long-term Evolution of Sign and Symptoms, and Occurence of Complications in Dry Eye Patients With Severe Keratitis Receiving Ikervis® (1mg/mL Ciclosporin)

Santen SAS·interventional·Posted Oct 30, 2019·Updated Aug 28, 2024

In Brief

A Phase 3 clinical trial evaluating Open-label Ikervis, Masked Ikervis, and 1 other intervention for Dry Eye Disease With Severe Keratitis. Completed, enrolled 350 participants across 45 sites in 7 countries.

Detailed Summary

The proposed 36-month Post Approval Efficacy Study (PAES) is a prospective, interventional, multicentre study to explore the long-term evolution of signs and symptoms, and occurrence of complications in Dry Eye Disease (DED) patients with severe keratitis receiving Ikervis® (1mg/mL ciclosporin) eye drops administered once daily

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Disease With Severe Keratitis
CountriesCzechia, France, Italy, Poland, Russia, Spain, Turkey (Türkiye)
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedOct 30, 2019
Enrollment StartMay 31, 2019
Primary CompletionJul 14, 2023
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 6.7 years ago

Interventions

Open-label Ikervisdrug

NOVA22007, IKERVIS® is a sterile, ophthalmic cationic oil-in-water emulsion containing 1mg/ml CsA.

Masked Ikervisdrug

NOVA22007, IKERVIS® is a sterile, ophthalmic cationic oil-in-water emulsion containing 1mg/ml CsA.

Vehicle Comparator: Masked Vehicleother

Vehicle of IKERVIS® - sterile, ophthalmic cationic oil-in-water emulsion containing no active substance.