Efficacy and Safety Assessment of T1580 versus Vehicle in Dry Eye Disease Treatment - LT1580-301

ABORATOIRES THEA0 个研究点目标入组 450 人开始时间: 2021年9月7日最近更新: 2021年10月8日

研究概览

暂无简介。

•1.1. Informed consent signed and dated by Screening visit.
•1.2. Menopausal woman.
•1.3. Final menstrual period at least 3 years before the Screening visit.
•1.4. Patient with BILATERAL persistent DED having required continuous tear substitute for the last 2 years at Screening visit.
•1.5. Patient with at least ONE eye with:
•a. Schirmer test without anaesthesia scored = 2 mm/5 min, and < 10 mm/5 min at Screening visit,
•b. Keratitis with a count of corneal dots stained by fluorescein > 32 dots AND corresponding to a grade 3 or a grade 4 on the Oxford scale at Baseline visit (please, refer to Oxford scale).
•1.6. Patient with Ocular Surface Disease Index (OSDI) = 23 (i.e., at least moderate symptomatology of DED) at Baseline visit.
•1.7. Patient having completed the patient daily diary on ocular symptoms during period # 2 of run-in at Baseline visit (only one day with missing data is permitted).
•1.8. Patient not having instilled any drop at least 6 hours prior to corneal fluorescein staining (CFS) assessment at Baseline visit.
•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 270
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 180

•Presence of an active condition :
•a. Ocular rosacea, uveitis,
•b. Abnormal eye lid anatomy, blinking, or naso-lachrymal drainage system,
•c. Ocular hypertension or glaucoma requiring an ophthalmic medicinal product,
•d. Infectious conjunctivitis, severe blepharitis, and/or progressive pterygium.
•Major corneal hypoaesthesia value = 20 mm as measured with a Cochet-Bonnet aesthesiometer.
•Far best corrected visual acuity (BCVA) worse than or equal to + 0.7 LogMar.
•Any history of, or active, relevant ocular disorder condition other than those listed above which is likely to interfere with the study results as judged by the investigator at Screening or Baseline visits. Any ophthalmic disease likely to change the assessment of fluctuating blurred vision linked to dry eye disease or may result in a visual acuity deterioration in the following year.
•Other exclusion criteria are defined in the protocol (Exclusion criteria regarding ocular history, Systemic/non Ophthalmic Exclusion Criteria, Specific Exclusion Criteria Regarding Childbearing Potential Women, Exclusion Criteria Related to General Conditions).

发起方

ABORATOIRES THEA