Efficacy and Safety Assessment of T4020 Versus Vehicule in Patients With Chronic Neurotrophic Keratitis or Corneal Ulcer

Thea Pharma

Status and phase: Completed; Phase 3

Conditions: Corneal Ulcer; Keratitis

Treatments: Device: T4020; Device: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT01794312

LT4020-PIII-12/11

Details and patient eligibility

About

The purpose of this study is to assess the efficacy and safety of T4020 versus vehicle.

Enrollment: 152 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients diagnosed with one chronic keratitis/corneal ulcer
• Patients who signed and dated informed consent

Exclusion criteria

• Patient under 18 years
• Patient with a perforated corneal ulcer OR any risk of immediate perforation of corneal ulcer.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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152 participants in 2 patient groups, including a placebo group

T4020

Experimental group

Description:

One drop every 2 days

Treatment:

Device: T4020

Vehicle

Placebo Comparator group

Description:

One drop every 2 days

Treatment:

Device: Vehicle