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

Phase 1

Conditions: ocular dryness (Dry Eye Disease - DED)
MedDRA version: 18.0Level: LLTClassification code 10013778Term: Dry eyesSystem Organ Class: 100000004853
MedDRA version: 18.0Level: LLTClassification code 10013777Term: Dry eye syndromeSystem Organ Class: 100000004853
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2015-000937-54-ES

Lead Sponsor: DRUG DELIVERY SOLUTIONS ApS (PART OF MC2 BIOTEK GROUP)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 264

Inclusion Criteria

1.Patients are at least 18 years of age
2.Patients with at least a 3 month documented history of moderate to severe DED 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

Patients presenting with any of the following will not be included in the study:
1.History of the disease for less than 3 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).