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 @ 4:42 AM
Ignite Modification Date:
2025-12-25 @ 4:42 AM
NCT ID:
NCT03398018
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Severe keratoconjunctivitis sicca (KCS) as defined by meeting at least three of the following in the same or both eye(s): (1) OSDI ≥ 33, (2) sum corneal staining with fluorescein of ≥ 5 in at least one eye, (3) MMP-9 concentration ≥ 40 ng/ml in at least one eye as measured by InflammaDry®, and (4) bulbar hyperemia of ≥ 2.0 in at least one eye as measured by the Oculus Keratograph® 5M
* Recalcitrant or intolerant to treatment with cyclosporine 0.05% ophthalmic emulsion (Restasis®) or lifitegrast 5% ophthalmic solution (Xiidra®)
Exclusion Criteria:
* Past or present history of: scleroderma, osteoporosis, systemic bacterial or fungal infection (including but not limited to tuberculosis), psychosis, ocular herpes simplex, peptic ulcer, congestive heart failure, diabetes mellitus, myasthenia gravis, hypothyroidism, liver cirrhosis, primary adrenocortical insufficiency or adrenocortical hyperfunction, central serous chorioretinopathy.
* Any corticosteroid use within 60 days of study enrollment
* Topical cyclosporine 0.05% ophthalmic emulsion (Restasis) or lifitegrast 5% ophthalmic solution (Xiidra) use within 60 days of study enrollment
* Recent surgery within 90 days
* Current uncontrolled, sustained hypertension
* Post-prandial blood glucose value of ≥ 140 mg/dl as measured at the baseline visit
* Sensitivity to proteins of porcine origin
* Anticipated administration of live or live attenuated vaccines during the course of the study
* Known sensitivity to steroid or complications from prior steroid use that subject is unwilling to tolerate
* Pregnancy (as assessed by urine hCG) or nursing
* Participation in a clinical trial involving a drug or device within the past 30 days
* Investigator discretion based upon medical history and/or opinion of ability to maintain protocol compliance
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03398018
Study Brief:
Protocol Section:
NCT03398018