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 @ 4:10 AM
Ignite Modification Date:
2025-12-25 @ 4:10 AM
NCT ID:
NCT02126020
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 80 years
* Able to provide informed consent
* Underlying diagnosis of SJS, TENS, or MMP
* Implantation of a Boston KPro type I
* Able to administer eye medications or have a care giver able and willing to do same
* Negative tuberculosis screening
Exclusion Criteria:
* Active or recurrent ocular or systemic infection
* Chest radiography, QuantiFERON-TB Gold or purified protein derivative (PPD) evidence of active or latent tuberculosis infection
* Indeterminate initial and repeat QuantiFERON-TB Gold results
* History of Bacille Calmette-Guerin (BCG) vaccination within twelve months of screening
* History of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, prior to screening
* Chest radiograph within three months prior to the first administration of the study drug that shows an abnormality suggestive of a malignancy or current active infection, including tuberculosis.
* History of a nontuberculous mycobacterial infection or opportunistic infection (e.g. cytomegalovirus, pneumocystosis, aspergillosis) within six months prior to screening
* history of hepatitis B virus
* Methicillin resistant Staphylococcus aureus (MRSA) or vancomycin resistant enterococcus (VRE) infection
* Malignancy diagnosed in the last five years
* Demyelinating disease
* History or current diagnosis of diabetes mellitus (controlled and uncontrolled)
* Heart failure (New York Heart Association class III or IV)
* Pregnancy or breast-feeding
* Scheduled to receive a live vaccine at any time point during study participation
* Allergy to infliximab or any of the compounds in its topical formulation or any chemically-related medication
* Prior or current use of systemic anti-tumor necrosis alpha-α medications or currently receiving treatments of Kineret (Anakinra)
* KPro designs with less than 16 holes in the back plate (to avoid the confounder of corneal nutrition)
* Inability to comply with the instillation of additional drops
* Unable to attend postoperative visits or administer medications, or no care giver available and willing to assist with same
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02126020
Study Brief:
Protocol Section:
NCT02126020