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Rebamipide

Phase 3

Keratoconjunctivitis Sicca | Small molecule | Ophthalmology |Novartis AG|Last Updated: Jan 7, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials2
Total Enrollment1,480

FDA Designations

No designations recorded

Clinical trial landscape

Rebamipide · 2 trials · 1 indication

Phase 3 2
NCT00201981Study of Rebamipide Eye Drops to Treat Dry EyeKeratoconjunctivitis Sicca
COMPLETED740 Analytics
NCT00201955Study of Rebamipide Eye Drops to Treat Dry EyeKeratoconjunctivitis Sicca
COMPLETED740 Analytics
PHASE3COMPLETED
Study of Rebamipide Eye Drops to Treat Dry Eye
Keratoconjunctivitis SiccaUnlock trial analytics
PHASE3COMPLETED
Study of Rebamipide Eye Drops to Treat Dry Eye
Keratoconjunctivitis SiccaUnlock trial analytics

Study Endpoints

Primary Endpoints

fluorescein corneal staining (FCS) total score at week 12 and the average primary ocular discomfort (POD) severity score at week 12
12 week and 26 week

Secondary Endpoints

fluorescein corneal staining (FCS) total score at week 26 and the average primary ocular discomfort (POD) severity score at week 26
12 week and 26 week
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATORrebamipide 1%
2ACTIVE_COMPARATORRebamipide 2%
3NO_INTERVENTIONplacebo

Interventions

NameTypeDescription
RebamipideDRUG1. OPC as a single drop per eye (approx 50 µL) 4 times per day for 52 weeks 2. OPC as a single drop per eye (approx 50 µL) 4 times per day for 52 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites63

Inclusion Criteria: * must have symptoms of dry eye for a minimum of 6 months * must be able to sign and date an informed consent Exclusion Criteria: * presence of anterior segment disease * glaucoma or ocular hypertension * using Restasis * use of topically instilled ocular medications during st...

Countries:United States
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Frequently asked questions about Rebamipide

What is Rebamipide used for in Keratoconjunctivitis Sicca?

Rebamipide is an investigational small molecule being studied for the treatment of Keratoconjunctivitis Sicca, commonly known as dry eye syndrome. It is developed by Novartis AG (NVS) and is currently in Phase 3 clinical development. The drug is administered as eye drops and is intended to address the symptoms of this condition.

What does Rebamipide target?

Rebamipide is a small molecule developed for ophthalmology, specifically for Keratoconjunctivitis Sicca (dry eye). Its mechanism of action involves promoting mucin production in the conjunctival epithelial cells, which helps stabilize the tear film and protect the ocular surface. This activity is relevant for patients with dry eye disease.

Who makes Rebamipide?

Rebamipide is being developed by Novartis AG, a global healthcare company traded on the New York Stock Exchange under the ticker NVS. The drug is currently in Phase 3 clinical trials for the treatment of Keratoconjunctivitis Sicca, also known as dry eye syndrome.

What phase is Rebamipide in?

Rebamipide is in Phase 3 clinical development for Keratoconjunctivitis Sicca (dry eye). It is an investigational drug, meaning it has not yet been approved by regulatory authorities. Two Phase 3 trials have been completed, each enrolling 740 participants, with a total of 1,480 patients across both studies.

What clinical trials is Rebamipide in?

Rebamipide has been studied in two Phase 3 clinical trials, both completed. The trials are NCT00201955 and NCT00201981, each titled 'Study of Rebamipide Eye Drops to Treat Dry Eye.' Both enrolled 740 participants with Keratoconjunctivitis Sicca in the United States, with a minimum age of 18 years.

Is Rebamipide the same as any other drug?

Rebamipide is a distinct drug entity developed by Novartis AG for Keratoconjunctivitis Sicca. It is not known by any other names in the clinical trial data. The drug is being evaluated as an eye drop formulation in Phase 3 studies, and no alternative names have been reported.