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 @ 12:45 PM
Ignite Modification Date:
2025-12-24 @ 12:45 PM
NCT ID:
NCT02369861
Eligibility Criteria:
Inclusion Criteria:
1. Subjects ages 18 years and older.
2. Subjects with symptoms and signs of Dry Eye for \> four months supported by previous clinical diagnosis or self-reported history.
3. Visual acuity corrected 20/40 or better in each eye.
4. If wearing contact lenses, subjects must be willing to refrain from wearing the contact lenses during the study (including washout period).
5. Score of 25-75 on the Ocular Surface Disorder Index (OSDI) questionnaire.
6. Corneal staining of grade 2 or more anywhere on the cornea (scale 0-4).
Exclusion Criteria:
1. Pregnant or breast feeding.
2. Anterior segment disease other than Dry Eye which in the opinion of the investigator would confound the study.
3. Macular and neovascular eye diseases
4. History of corneal surgery or LASIK (laser in situ keratomileusis) surgery in either eye within the past year.
5. Use of cyclosporine, steroid eye drops, serum eye drops, or any other eye medication (except for artificial tears) or experimental drug within the past 30 days.
6. Subjects with glaucoma or in whom glaucoma is suspected.
7. Use of anticholinergic drugs, antihistamines, beta-blockers, or tricyclic anti-depressants within the past 30 days.
8. Asymmetric punctal plugs or punctal cauterization within the past three months.
9. History of Stevens-Johnson disease, ocular cicatricial pemphigoid, alkali burn of the eye, or graft-versus-host disease.
10. Immune compromise for any reason.
11. Kidney or liver function studies \>2x the upper limit of normal.
12. Symptomatic abnormalities od the lid.
13. History of cancer within the past 5 years
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02369861
Study Brief:
Protocol Section:
NCT02369861