Acanthamoeba keratitis AK
Conditions
Interventions
The study consists of an eligibility screening visit, 1 treatment period
including short ambulant visits, and a follow-up visit.
In total 90 subjects will be assigned to one of the following 4 treat
Sponsors
SIFI SpA
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subject must have bilateral best corrected visual acuity >6/10. Subject must have intraocular pressure (IOP) 14-21 mmHg. Subject*s ophthalmologic examination must be without abnormalities.
Exclusion criteria
Exclusion criteria: 1. Subject with presence of bacterial ocular infections. 2. Subject with presence of any concomitant ocular pathology. 3. Subject performs activities likely to result in an irritated conjunctiva during the study (including heavy alcohol intake, swimming in chlorinated water and heavy smoking). 4. Subject wearing contact lenses at screening until follow-up. 5. Subject with ocular surface fluorescein staining score >3. 6. Subject who used topical or systemic antibiotics, antihistamines, decongestants and non-steroidal anti-inflammatory agents as well as steroids within 7 days before screening. 7. Subject with known or suspected allergy to biguanides or intolerance to any other ingredient of the test treatments. 8. Subject who underwent ocular surgery. 9. Subjects participating in another clinical study or who had participated in a clinical study in the preceding 30 days. 10. Subjects who have only one functional eye.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The determination of the sample size is based on the following: a total number of 80 evaluable subjects (24 per PHMB treatment group and 8 in placebo group) is considered sufficient for the purpose of the present study for the following reasons: Based on the binomial probability distribution function, if no serious adverse events (SAEs) are observed in a group of 24 subjects, it can be concluded (with 95% confidence) that the true SAE rate is unlikely to be higher than 11.8%. Safety and tolerability of 3 different concentrations will be compared to placebo (3 null hypotheses): * No difference between dose 1 and placebo * No difference between dose 2 and placebo * No difference between dose 3 and placebo Assuming a dropout rate of 10%, the study will aim to recruit 90 subjects. | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma PHMB concentrations will be presented in a descriptive way. | — |
Countries
Netherlands
Outcome results
None listed