Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT02113293
Eligibility Criteria:
Inclusion Criteria:
* Healthy male or female subject aged 18 - 45 years
* Nonsmoker, for at least three months prior to first dose of trial medication
* BMI from 18.5 to 29.9 (kg/m2)
* Corneal/Conjunctival staining Oxford grading = 0°
* Schirmer I more than 10 mm/5min
* Tear Film Break-Up Time (TFBUT) equal or more than 10 s
* Intra-ocular pressure between 10 and 20 mmHg
* Normal funduscopy
* Subject will have given their voluntary written informed consent to participate in the study in their own language and are willing to comply with the protocol
Exclusion Criteria:
* History of clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing)
* History of dry eye disease, ocular surgery, corneal disease
* Known hypersensitivity to the drug substance
* Limbal stem cell deficiency
* Cicatricial pemphigoid
* Glaucoma or known steroid response on intraocular pressure
* Ocular allergy or incompatibility against Ciclosporin or semifluorinated alkanes
* Punctual occlusion
* Corrected vision with glasses less than 0.7 on one or both eyes
* Contact lens wear 3 weeks before to the planned first drug administration and/or during the study
* Acute infection of ocular surface (bacterial, viral, fungal...)
* Acute trauma of ocular surface
* No acceptable methods of birth control
* Pregnancy or breast-feeding period (females only)
* Use of any drugs whatsoever (including vitamins and herbals) for fourteen (14) days prior to the planned first drug administration (excluding contraceptives in women and single use of paracetamol or ibuprofen)
* Topical or systemic therapy with steroids, Ciclosporin, non-steroidal anti- inflammatory drugs, tetracyclines or other immunomodulatory substances within last 90 days prior to the planned first drug administration or during this trial
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02113293
Study Brief:
Protocol Section:
NCT02113293