Chronic neurotrophische keratitis & Chronische neurotrophische corneal ulcus
Conditions
Interventions
Intervention :
- Informed Consent Form will be recovered prior the first visit (selection
visit = V1)
- Questionnary during 1st visit : demography, ocular medical and surgical
history, Systemic m
Sponsors
LABORATOIRES THEA
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: At Selection Visit (Visit 1) - Signed and dated informed consent, - Male or female aged * 18 years, - Patient with one chronic neurotrophic keratitis or one chronic neurotrophic corneal ulcer defined by: A maximal depth * 2/3 of the stroma and a partial or complete corneal anaesthesia;At Inclusion Visit (Visit 2) - No improvement of the chronic neurotrophic keratitis or chronic neurotrophic corneal ulcer after 7 days with preservative free lachrymal substitute treatment (NaCl 0.9%).
Exclusion criteria
Exclusion criteria: Ophthalmic non-inclusion criteria;In the affected eye: - Risk of immediate perforation of corneal ulcer. - Descemetocele. - Perforated corneal ulcer. - Corneal abscess.;In the controlateral eye: - Best far corrected visual acuity * 1/10.;In both eyes: - Active ocular infection. - Glaucoma / ocular hypertension;Systemic/non ophthalmic non-inclusion criteria;- General history judged by the investigator to be incompatible with the study (life-threatening patient condition). - Known allergic hypersensitivity history to one of the components of the study medications or to test products.;Specific non-inclusion criteria for women - Pregnancy, lactation. - Childbearing women without an effective method of contraception (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant, vaginal ring) or women not hysterectomised, menopaused or surgically sterilized.;Non-inclusion criteria related to general conditions - Inability of patient and/or relatives to understand the study procedures and thus inability to give informed consent. - Non-compliant patient and/or relatives (e.g. not willing to attend the follow-up visits, way of life interfering with compliance). - Participation in another clinical study within the last 3 months. - Already included once in this study. - Ward of court. - Patient not covered by the Social Security scheme (For France).;CONCOMITANT MEDICATIONS / NON PRODUCT THERAPIES NOT ALLOWED BEFORE (7 days before Visit 1) AND DURING THE STUDY - Any plan or predicable change in dose regimen for the following systemic treatments (anti-inflammatory drugs, psychotropic drugs) - Contact lenses wear;CONCOMITANT MEDICATIONS / NON PRODUCT THERAPIES NOT ALLOWED DURING THE STUDY - Any systemic steroids treatment - Any topical ocular treatments except allowed treatments (Allowed treatments = cyclosporine preservative free + free artificial tears: NaCl 0.9% 3 to 8 times daily)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of the study is : - Reduction of 50% or more in Keratitis/ulcer area from baseline assessed at Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| The secundary outcome of the study is : Clinical efficacy - Complete corneal healing at Day 28. - Partial response at Day 28 defined as a reduction in the ulcer/keratitis area of 75% or more. - Partial Response (50%) at Day 28 defined by investigator judgment. - Complete corneal healing at Day 28 defined by investigator judgment. - Complete corneal healing at Day 7, Day 14 and Day 21. - Partial response at Day 7, Day 14 and Day 21 defined as a reduction in the ulcer/keratitis area of 75% or more. - Partial response at Day 7, Day 14 and Day 21 defined as a reduction in the ulcer/keratitis area of 50% or more. - Partial Response (50%) at Day 7, Day 14 and Day 21 defined by investigator judgement. - Complete corneal healing at Day 7, Day 14 and Day 21 defined by investigator judgement. - Corneal ulcer/keratitis depth assessment at Day 7, Day 14, Day 21 and Day 28. Ocular and systemic safety - Best corrected visual acuity at Day 28. - Global tolerance assessed by the investigator at Day 7, Day 14, Day 21 and Day 28. - Global tolerance assessed by the patient at Day 7, Day 14, Day 21 and Day 28. - Adverse events recorded from Day 0 and throughout the study. - Ocular pain assessment with the Visual Analog Scale. - Use of analgesics treatments. | — |
Countries
Netherlands
Outcome results
None listed