Efficacy/Safety of Human Plasminogen Eye Drop in Ligneous Conjunctivitis Patients

Inclusion Criteria:

• Subjects should be diagnosed with ligneous conjunctivitis associated with Type I plasminogen deficiency, confirmed by the central laboratory and documented at pre-enrollment screening. The concomitant presence of other ligneous pseudomembranes at different sites will not constitute an exclusion criterion.
• Subjects should have documented historical record or knowledge of lifetime disease course, including age of LC onset, history of pseudomembrane lesions, disease duration, past treatment for LC, response to treatment (including regression and recurrence) available for at least 6 months before study entrance.
• Subjects, or their legally authorized representative, in the case of study participants < 18 years of age, should have been informed of the nature of the study, agreed to its provision, signed and dated the informed consent approved by the investigational review board (IRB) or ethics committee (EC).
• Subjects available for the duration of the study will be included.

Exclusion Criteria:

• Subjects presenting ligneous conjunctivitis not associated with Type 1 plasminogen deficiency.
• Subjects with any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives, or participation in this trial.
• Subjects unwilling to give written informed consent or assent to participation.
• Subjects who have participated in another clinical trial within 1 month before study initiation, i.e. they have received any test drug within 30 days prior the study.
• Females of childbearing potential who are either pregnant or not using an adequate method of birth
• Females who are breastfeeding.