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

• Register: EUCTR
• Last refreshed on: 28 February 2019
• Main ID: EUCTR2015-005405-36-HU
• Date of registration: 21/04/2016
• Prospective Registration: Yes
• Primary sponsor: Laboratoires Théa
• Public title: Efficacy and Safety Assessment of T1580 versus Vehicle in Dry Eye Disease Treatment
• Scientific title: EFFICACY AND SAFETY ASSESSMENT OF T1580 VERSUS VEHICLE IN DRY EYE DISEASE TREATMENT
• Date of first enrolment: 17/05/2016
• Target sample size: 450
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-005405-36
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: The first 6-month period will be double-masked followed by an open-label 6-month treatment period If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Armenia, Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Croatia, Czech Republic, Estonia, Georgia, Greece, Hungary, Israel, Italy, Latvia, Lithuania, Macedonia, the former Yugoslav Republic of, Mexico, Poland, Romania, Russian Federation, Serbia, Slovakia, Slovenia, Spain, Tunisia, Ukraine, United Kingdom

Contacts

• Name: Clinical department
• Affiliation: Laboratoires Thea

• Name: Clinical department
• Affiliation: Laboratoires Thea

Key inclusion & exclusion criteria

Inclusion criteria:
Informed consent signed and dated
Menopausal woman.
Patient with BILATERAL persistent DED

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

Exclusion criteria:
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).


Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Eye Diseases [C11]

Dry Eye
MedDRA version: 19.0 Level: LLT Classification code 10013778 Term: Dry eyes System Organ Class: 100000004853
MedDRA version: 19.0 Level: LLT Classification code 10013777 Term: Dry eye syndrome System Organ Class: 100000004853

Intervention(s)

Product Name: Ciclosporin
Product Code: T1580
Pharmaceutical Form: Eye drops, solution in single-dose container
INN or Proposed INN: CICLOSPORIN
CAS Number: 59865-13-3
Current Sponsor code: T1580
Concentration unit: % (W/V) percent weight/volume
Concentration type: equal
Concentration number: 0.1-
Pharmaceutical form of the placebo: Eye drops, solution in single-dose container
Route of administration of the placebo: Ocular use

Primary Outcome(s)

Secondary Objective: The secondary objective is to evaluate the safety of T1580.

Main Objective: The primary objective of this study is to evaluate the efficacy of T1580 versus vehicle in Dry Eye Disease (DED).

Primary end point(s): The change from Baseline in Corneal Fluorescein Staining (CFS)

Timepoint(s) of evaluation of this end point: Assessed at Month 6

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Key Secondary efficacy Endpoints
Assessed at Month 6

Secondary end point(s): Key Secondary efficacy Endpoints
-CFS response to treatment
-Combined CFS and OSDI response to treatment

Secondary ID(s)

2015-005405-36-BE

LT1580-301

Source(s) of Monetary Support

Laboratoires Théa

Ethics review

Status: Approved
Approval date:
Contact: