NL-OMON44908已完成3 期
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. - Clinical Study Protocol N° LT4020-PIII-12/11
ABORATOIRES THEA0 个研究点目标入组 4 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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%).
排除标准
- •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)
研究者
相似试验
已完成
3 期
Efficacy and Safety Assessment of T4020 Versus Vehicule in Patients With Chronic Neurotrophic Keratitis or Corneal UlcerCorneal UlcerKeratitisNCT01794312Laboratoires Thea152
进行中（未招募）
1 期
Efficacy and Safety Assessment of T1580 versus Vehicle in Dry Eye Disease TreatmentDry Eye DiseaseMedDRA version: 21.1Level: LLTClassification code 10013778Term: Dry eyesSystem Organ Class: 100000004853MedDRA version: 21.1Level: LLTClassification code 10013777Term: Dry eye syndromeSystem Organ Class: 100000004853EUCTR2015-005405-36-ITABORATOIRES THEA450
进行中（未招募）
1 期
Efficacy and safety assessment of T4032 versus Lumigan® in ocular hypertensive or glaucomatous patients.glaucoma, ocular hypertensionMedDRA version: 20.0Level: HLGTClassification code 10018307Term: Glaucoma and ocular hypertensionSystem Organ Class: 10015919 - Eye disordersEUCTR2017-000846-23-ITABORATOIRES THEA434
进行中（未招募）
1 期
Efficacy and safety assessment of T4032 versus Lumigan® in ocular hypertensive or glaucomatous patients.glaucoma, ocular hypertensionMedDRA version: 20.0Level: HLGTClassification code 10018307Term: Glaucoma and ocular hypertensionSystem Organ Class: 10015919 - Eye disordersEUCTR2017-000846-23-LTaboratoires THEA668
进行中（未招募）
1 期
Efficacy and safety assessment of T4032 versus Lumigan® in ocular hypertensive or glaucomatous patients.glaucoma, ocular hypertensionMedDRA version: 20.0 Level: HLGT Classification code 10018307 Term: Glaucoma and ocular hypertension System Organ Class: 10015919 - Eye disordersEUCTR2017-000846-23-GBaboratoires THEA668