Dry Eye Syndromes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients with a diagnosis of severe mixed dry eye; Patients with a therapeutic indication for the use of topical blood components on the ocular surface; Patients who agree to participate in the study and sign the Informed Consent Form (ICF); Minimum age of 18 years; Both sexes
Exclusion criteria
Exclusion criteria: Patients with an active ocular infection at the time of data collection; Pregnant or lactating patients; Patients who have had changes in pre-existing topical eye medications after the start of the study; Patients unable to attend all evaluations required by the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected that there will be no clinically relevant difference between the eye drops prepared by the conventional (liquid) method and the lyophilized eye drops in the treatment of dry eye, considering the symptom- and sign-based measures assessed at the end of 30 days of use in each phase of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to observe improvement in the dry eye parameters assessed with all storage/preparation methods of the eye drops (conventional and lyophilized), and no clinically relevant difference is expected among the types of blood-derived eye drops used (autologous serum, platelet-rich plasma, and plasma rich in growth factors) | — |
Countries
BR
Contacts
Universidade Estadual de Campinas