Patients suffering from keratitis or keratouveitits of infectious origin
Conditions
Interventions
Product Code: GS101 0.43mg/ml
Pharmaceutical Form: Eye drops*
Pharmaceutical form of the placebo: Eye drops*
Route of administration of the placebo: Intraocular use
Product Code: GS101 0.86mg/ml
Phar
Sponsors
Les Laboratoires CTRS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Men or non-pregnant women. At least 18 years old. Suffering from keratitis or keratouveitis due to contact lens microbial keratitis, bacteria or other microorganisms, viruses, protozoa, immunologic diseases, trauma or prior surgery, alkali burns, graft rejection or degenerative disorders. Evidence of documented progression of neovascularisation during a period of minimum 2 weeks and maximum 3 months before inclusion Patients who are able to understand the protocol and give informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pregnancy. Patients who cannot communicate reliably with the investigator. Patients who are unlikely to cooperate with the requirements of the study Patients who are unwilling and/or unable to give informed consent Patients suffering from a life-threatening progressive disease Patients participating in another clinical study Patients who have used any other investigational drugs within 1 month of first dosing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of 3 doses of GS101 eye drops in prevention or decrease of neovascularisaton of the cornea (epithelial and stromal);Secondary Objective: To determine the efficacy of GS101 with regard to the visual acuity;Primary end point(s): Progression of corneal (epithelial or stromal) neovascularisation. | — |
Countries
Germany
Outcome results
None listed