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 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT05945069
Eligibility Criteria:
Inclusion Criteria:
* Subject is able to read, understand and sign an Informed Consent Form (ICF)
* 22 or older
* Lower lid laxity, as clinically judged with lower lid DT and the snapback test
* Moderate to severe OSDI (larger or equal to 23)
* TBUT smaller or equal to 5 sec in both eyes
Exclusion Criteria:
* Abnormally high blink rate, as estimated by the study investigator
* Any ocular surgery or eyelid surgery, within 3 months prior to screening
* Blepharoptosis
* Moderate or Severe Floppy Lid Syndrome
* Corneal Dystrophy
* Exophthalmos
* Thyroid Eye Disease
* Ocular Chemical Injury or burn
* Limbal Stem Cell Deficiency
* Facial Nerve Palsy
* Blepharospasm
* Hemifacial Spasm
* Corneal neuropathy
* Pregnant or nursing women
* Participation in a different study
* Any condition revealed whereby the study investigator deems the subject inappropriate for this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT05945069
Study Brief:
Protocol Section:
NCT05945069