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 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT02219204
Eligibility Criteria:
Inclusion Criteria:
1. Age: 40-85 years, visual acuity better than logMAR of 1.0
2. Chief complaint should be dry eye
3. Symptoms:
3.1. SPEED score \> 6
3.2. TCM score satisfies lung-kidney yin deficiency profile
4. Signs:
4.1. TBUT (\<10s) or Schirmer's test (\<10mm/5 mins) 4.2 Any corneal fluorescein staining
Exclusion Criteria:
1. Glaucoma or other ophthalmic disease, eg. Extraocular muscle palsies, ectropion, entropion
2. Ocular allergies, eg. Allergic conjunctivitis, sinusitis, eczema, atopic keratoconjuntivitis
3. Known of thyroid disorders (diagnosed by physician)
4. Trichiasis
5. Eye surgeries patients including LASIK (within 1 year)
6. Steven-Johnson syndrome
7. Sjogren's syndrome
8. Eye related trauma (within 1 year)
9. Contact lens wear (within 1 year)
10. Punctal occlusion
11. Systemic disease requiring regular medication (except hypertension and lipidemia)
12. Pregnancy or planning to be pregnant
13. Requirement for medications such as anti-microbial, inflammatory, creams (except moisturizers or cosmetics), or steroidal therapies
14. Unable to do this clinical trial for any reason
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
85 Years
Study:
NCT02219204
Study Brief:
Protocol Section:
NCT02219204