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

EFFICACY AND SAFETY ASSESSMENT OF T1580 VERSUS VEHICLE IN DRY EYE DISEASE TREATMENT

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005405-36-BE

Enrollment

450

Registered

2016-04-21

Start date

2016-05-10

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye MedDRA version: 20.0 Level: LLT Classification code 10013778 Term: Dry eyes System Organ Class: 100000014904 MedDRA version: 20.0 Level: LLT Classification code 10013777 Term: Dry eye syndrome System Organ Class: 100000014904

Interventions

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 Con

Eligibility

Sex/Gender

All

Inclusion 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

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).

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to evaluate the efficacy of T1580 versus vehicle in Dry Eye Disease (DED).;Secondary Objective: The secondary objective is to evaluate the safety of T1580.;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

Measure	Time frame
Secondary end point(s): Key Secondary efficacy Endpoints -CFS response to treatment -Combined CFS and OSDI response to treatment ;Timepoint(s) of evaluation of this end point: Key Secondary efficacy Endpoints Assessed at Month 6	—

Countries

Armenia, Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Czech Republic, Estonia, Georgia, Greece, Hungary, Italy, Latvia, Lithuania, Poland, Romania, Russian Federation, Serbia, Spain, Ukraine, United Kingdom

Contacts

Public ContactClinical department

Laboratoires Thea

s.guyon@theapharma.com00 33 4 73 98 14 36

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026