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 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT03569202
Eligibility Criteria:
Inclusion Criteria:
1. Ability and willingness to give informed written consent prior to any screening procedure after explanation of the nature and possible consequences of the study.
2. Age between 18 and 80 years.
3. At least two the following conditions (A and B):
A. Symptomatic dry eye with OSDI score ≥20. AND B1. Tear film break-up time (TBUT) \<10 seconds. OR B2. Positive ocular (corneal and conjunctival) staining pattern
4. Body weight at least 45 kg.
5. Under stable topical and/or systemic therapy for at least 4 weeks before the study procedures and apparent ability and willingness to abstain from other therapies until completion of the study period.
6. Ability and willingness to self-administer eye drops.
7. Ability and willingness to understand and fill in the OSDI questionnaire.
8. Ability and willingness to comply with the study protocol and other study-related procedures.
Exclusion Criteria:
1. History of ocular surgery, trauma, or refractive laser vision correction procedure less than 3 months earlier.
2. Evidence of acute or chronic infection in the cornea or conjunctiva.
3. Diagnosis of Sjögren's syndrome.
4. Unwillingness or apparent disability to discontinue contact lens use during study period and at least one week before the first dosing day.
5. Current ocular allergy symptoms.
6. Known allergy to any constituent of the trehalose emulsion eye drops or control eye drops.
7. Currently pregnant, nursing or planning to become pregnant before completion of the study period.
8. Any other condition that may, in the Investigator's opinion, jeopardize the safety or availability of the subject or adherence to the study protocol or may interfere with the interpretation of the results and would thus make the subject inappropriate for entry in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03569202
Study Brief:
Protocol Section:
NCT03569202