Evaluation of the safety and efficacy of PAD ciclosporin in dry eye patients

A phase II, multicenter, randomized, double-masked, 4 parallel arms, controlled 6-month trial designed to evaluate the safety and efficacy of PAD ciclosporin (CsA 0.06% and 0.03%) ophthalmic dispersion administered once daily in combination with lubricant therapy and a 3-month post-treatment safety follow-up in moderate to severe dry eye patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000937-54-GB

Enrollment

264

Registered

2015-04-21

Start date

2015-08-03

Completion date

Unknown

Last updated

2019-02-28

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

Conditions

ocular dryness (Dry Eye Disease - DED) 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: PADciclo 0.06% Pharmaceutical Form: Eye drops, emulsion INN or Proposed INN: CICLOSPORIN CAS Number: 59865-13-3 Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients are at least 18 years of age 2. Patients with at least a 12-month documented history of moderate to severe DED in both eyes persisting despite conventional management (which may include artificial tear drops, gels, ointments and/or punctual occlusion), and defined as the following: a. Corneal fluorescein staining (CFS) = 3 or 4 (modified Oxford scale, scale 0 – 5) AND b. Global ocular discomfort score of = 30mm using a 100 mm VAS. Patients will assess burning/stinging, foreign body sensation, eye dryness and pain and the mean score will be calculated: (where "0" means no symptom and "100" means the worst that have ever experienced). 3. Patients must provide written informed consent 4. Patients must be willing and able to undergo and return for scheduled study-related examinations. 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 77 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 143

Exclusion criteria

Exclusion criteria: Patients presenting with any of the following will not be included in the study: 1. History of the disease for less than 12 months (symptoms stabilized) 2. Best corrected distance visual acuity (BCDVA) score = +1.0 LogMAR (= 35 ETDRS letters, = 20/200 Snellen or = 0.1) in each eye 3. Within the 3 months before the screening visit, history of ocular trauma, infection (viral, bacterial, fungal), inflammation not associated with dry eye Other exclusion criteria are defined in the protocol (they are referring to the ocular history, the medical history and the contraindications to treatment).

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objectives of this study are to: 1. Evaluate the ocular tolerance and overall ocular safety of PADciclo (0.06% and 0.03%) in dry eye patients. 2. Evaluate the efficacy of PADciclo (0.06% and/or 0.03%) compared to current BSC administered once daily for 6 months in improving CFS in dry eye patients using a responder approach analysis. ; Secondary Objective: The key secondary study objective is to: 1. Evaluate the efficacy of PADciclo (0.06% and 0.03%) to current BSC administered once daily for 6 months in improving corneal fluorescein staining and global ocular discomfort score (VAS) in dry eye patients using a composite responder approach analysis. Additional secondary study objectives are to: 1. Evaluate the efficacy of PADciclo (0.06% and/or 0.03%) compared to PADciclo vehicle administered once daily for 6 months in improving CFS in dry eye patients using a responder approach analysis. 2. Evaluate the efficacy of PADciclo (0.06% and 0.03%) to PADciclo vehicle administered once daily for 6 months in improving corneal fluorescein staining and global ocular discomfort score (VAS) in dry eye patients using a composite responder approach analysis. 3. Compare efficacy of PADciclo 0.03% and PADciclo 0.06%. ; Primary end point(s): The primary safety variable is the incidence and severity of ocular and systemic adverse events throughout the study. The primary efficacy variable is CFS response in the worse eye at Month 6, defined as at least a 2-grade improvement from baseline, as assessed with the modified Oxford scale. ; Timepoint(s) of evaluation of this end point: Primary safety variable Timepoint: Baseline and Months 1, 3, 6 and 9 Primary efficacy variable Timepoint: at Month 6	—

Measure

Time frame

Main Objective: The primary objectives of this study are to: 1. Evaluate the ocular tolerance and overall ocular safety of PADciclo (0.06% and 0.03%) in dry eye patients. 2. Evaluate the efficacy of PADciclo (0.06% and/or 0.03%) compared to current BSC administered once daily for 6 months in improving CFS in dry eye patients using a responder approach analysis. ; Secondary Objective: The key secondary study objective is to: 1. Evaluate the efficacy of PADciclo (0.06% and 0.03%) to current BSC administered once daily for 6 months in improving corneal fluorescein staining and global ocular discomfort score (VAS) in dry eye patients using a composite responder approach analysis. Additional secondary study objectives are to: 1. Evaluate the efficacy of PADciclo (0.06% and/or 0.03%) compared to PADciclo vehicle administered once daily for 6 months in improving CFS in dry eye patients using a responder approach analysis. 2. Evaluate the efficacy of PADciclo (0.06% and 0.03%) to PADciclo vehicle administered once daily for 6 months in improving corneal fluorescein staining and global ocular discomfort score (VAS) in dry eye patients using a composite responder approach analysis. 3. Compare efficacy of PADciclo 0.03% and PADciclo 0.06%. ; Primary end point(s): The primary safety variable is the incidence and severity of ocular and systemic adverse events throughout the study. The primary efficacy variable is CFS response in the worse eye at Month 6, defined as at least a 2-grade improvement from baseline, as assessed with the modified Oxford scale. ; Timepoint(s) of evaluation of this end point: Primary safety variable Timepoint: Baseline and Months 1, 3, 6 and 9 Primary efficacy variable Timepoint: at Month 6

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Secondary

Measure	Time frame
Secondary end point(s): Secondary safety and tolerability variables: • BCVA assessed in both eyes • Slit lamp examination performed in both eyes • IOP recorded for both eyes • Vital signs (blood pressure and heart rate) • Ciclosporin concentration in plasma Key secondary efficacy variable • Composite response endpoint (defined in the protocol and based on an improvement from baseline in CFS and VAS) Other secondary efficacy variables are defined in the protocol (eg. CFS assessment at different timepoints, CFS improvement, VAS response, Shirmer test, TBUT...). ; Timepoint(s) of evaluation of this end point: Secondary safety and tolerability variables: Timepoint: Baseline and Months 1, 3, 6 and 9 for all variables except ciclosporin concentration which will be assessed at baseline and Month 6. Key secondary efficacy variable Timepoint: Month 6	—

Measure

Time frame

Secondary end point(s): Secondary safety and tolerability variables: • BCVA assessed in both eyes • Slit lamp examination performed in both eyes • IOP recorded for both eyes • Vital signs (blood pressure and heart rate) • Ciclosporin concentration in plasma Key secondary efficacy variable • Composite response endpoint (defined in the protocol and based on an improvement from baseline in CFS and VAS) Other secondary efficacy variables are defined in the protocol (eg. CFS assessment at different timepoints, CFS improvement, VAS response, Shirmer test, TBUT...). ; Timepoint(s) of evaluation of this end point: Secondary safety and tolerability variables: Timepoint: Baseline and Months 1, 3, 6 and 9 for all variables except ciclosporin concentration which will be assessed at baseline and Month 6. Key secondary efficacy variable Timepoint: Month 6

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Countries

Austria, Czech Republic, Denmark, France, Norway, Portugal, Slovakia, Spain, Switzerland, United Kingdom

Contacts

Public ContactClinical operations

DRUG DELIVERY SOLUTIONS ApS (PART OF MC2 BIOTEK GROUP)

mpr@mc2biotek.com+45 25 338 893

Outcome results

None listed

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