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 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 12:12 AM
NCT ID:
NCT01776658
Eligibility Criteria:
Inclusion Criteria:
* Patients of both genders
* Age ≥ 18 years old
* Give written informed consent to participate in the study after having been informed of the study design, objectives and possible derived risks
* Common mild to moderate dry eye symptoms. Persistent daily symptoms for more than three months:
* OSDI scale: 13-30
* VAS scale: 2-7
* Ocular tests in both eyes:
* Corneal staining with fluorescein. Oxford scale \> 0
* Tear Breakup Time Test: (BUT) \< 10 seconds
* Schirmer test with anaesthesia \< 10 mm/5min
Exclusion Criteria:
* Pregnant or breastfeeding females or those with a positive pregnancy test.
* Females of childbearing potential who will not use a medically acceptable contraceptive method from selection and during the whole study.
* Current relevant disease, including respiratory disease, cardiovascular, endocrine, neurological, haematological, renal, neoplasic, hepatopathy, gastrointestinal distress, hypertension, or infectious acute processes.
* Past history of a chronic o recurring condition that could interfere with study according to the investigator's judgement.
* Concomitant use of other drugs with analgesic activity by any route of administration at the enrolment period.
* Changes in any ocular and/or systemic concomitant medication one month prior to the study commencement and during the study development.
* Changes on the preestablished artificial tears dosage 15 days prior to the study commencement and during the study development.
* Cyclosporine treatment initiation or changes in cyclosporine dosage or dosing regimen during the 6 months prior to enrolment.
* Previous history of drug hypersensitivity.
* Use of contact lenses
* Case history of drug or alcohol abuse or dependence.
* Relevant abnormal laboratory results as judged by the investigator
* Previous refractive surgery
* Participation in a clinical trial within 2 months before the enrolment visit
* Relevant ocular pathology judged by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01776658
Study Brief:
Protocol Section:
NCT01776658