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 @ 2:14 PM
Ignite Modification Date:
2025-12-24 @ 2:14 PM
NCT ID:
NCT04357795
Eligibility Criteria:
Inclusion Criteria:
1. Male or female subjects with a history of bilateral dry eye disease for a period of at least 3 months.
2. Aged of at least 18 years.
3. Subjects with total corneal fluorescein staining ≥6 or corneal fluorescein staining in an individual zone ≥2 as per National Eye Institute Grading Scale.
4. Subjects with modified symptom assessment in dry eye global symptom score, ≥40 using visual analogue scale.
5. Subjects with best-corrected visual acuity 20/200 or better in both eyes at the Screening/Baseline visit
Exclusion Criteria:
1. Subjects who have used cyclosporin 0.05% ophthalmic emulsion in both eyes for less than 3 months prior to the Screening/Baseline visit.
2. Subjects with history of treatment failure with cyclosporin 0.05% ophthalmic emulsion.
3. Subjects who have active seasonal and/or perennial allergic conjunctivitis in either eye.
4. Subjects who had already Use initiated any systemic or topical ocular medication.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04357795
Study Brief:
Protocol Section:
NCT04357795