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:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT01051804
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years or more.
* Non contact lens wearer.
* Symptomatology as defined below for the Ocular Surface Disease Index (OSDI) questionnaire:
* Score ≥13 for OSDI Questionnaire total score; AND
* Scores of at least 2 for 2 out of the 6 vision related questions of the OSDI questionnaire
* Best visual acuity of 6/9 or better in each eye.
* Willingness to adhere to the instructions set in the clinical protocol.
* Signature of the subject informed consent form.
Exclusion Criteria:
* Use of systemic medication which might produce dry eye side effects.
* Systemic disease which might produce dry eye side effects.
* Active ocular infection.
* Use of ocular medication.
* Significant ocular anomaly.
* Previous ocular surgery
* Previous use of Restasis
* Any medical condition that might be prejudicial to the study.
* The subject, based on their knowledge, must NOT be pregnant or lactating at the time of enrolment.
* The subject, based on his/her knowledge, must NOT have an infectious disease (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. Human Immunodeficiency Virus).
* The subject, based on their knowledge, must NOT have diabetes.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01051804
Study Brief:
Protocol Section:
NCT01051804