Efficacy and Safety assessment of T4020 versus vehicle in patients with chronic neurotrophic keratitis or corneal ulcer. Phase III study, international, multicentre, randomised, double-masked, 2 parallel groups, versus vehicle, in 124 evaluable patients treated for 28 days.
- Conditions
- Chronic neurotrophische keratitis & Chronische neurotrophische corneal ulcus10015919
- Registration Number
- NL-OMON44908
- Lead Sponsor
- ABORATOIRES THEA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 4
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%).
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p> The primary outcome of the study is :<br /><br>- Reduction of 50% or more in Keratitis/ulcer area from baseline assessed at<br /><br>Day 28</p><br>
- Secondary Outcome Measures
Name Time Method