RBR-34d3jv2
Recruiting
Phase 1
Interventional clinical protocol for assessing the therapeutic efficacy of 50% Autologous Serum Eye Drops in the treatment of corneal epithelial defects in Inflammatory ocular surface diseases
niversidade Federal de São Paulo - UNIFESP/EPM0 sitesNovember 27, 2023
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversidade Federal de São Paulo - UNIFESP/EPM
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18 to 80 years. Both genders. Confirmed diagnosis of one of the following pathologies: Sjögren 's syndrome, Moderate to severe non\- Sjögren's dry eye, Stevens\-Johnson syndrome, Graft versus host disease, Neurotrophic keratitis, Neurotrophic pain. Presence of corneal epithelial defect without improvement after treatment with preservative\-free lubricating eye drops for at least 14 days. Absence of active infection on the ocular surface. No recent use of the following medications or performance of the following procedures: anticoagulants/ anti\- platelet aggregation, blood product eye drops in the last 3 months, eye surgery in the last 6 months. Does not present any of the following conditions: poorly controlled systemic disease, active infection or advanced\-stage cancer, pregnancy or breastfeeding. There are no contraindications to blood donation: positive serology for HIV I and II or HTLV 1/2 or hepatitis B or hepatitis C or syphilis or Chagas disease according to Ordinance 158 of 02/04/2016 of the Ministry of Health – Brazil, anemia (hemoglobin level \< 11\.0 mg/dl) or thrombocytopenia (platelet level \< 150 x 10 9 /L). Ability to adhere to the treatment and follow\-up protocol during the study period and provide written consent for participation
Exclusion Criteria
- •Diagnosis of active corneal infection. Pregnancy diagnosed after beginning the protocol. Loss of clinical follow\-up. Incorrect adherence to treatment, with application of less than 70% of the expected daily dose or remaining without use for more than one full day a week. Inadequate storage and care of eye drops. Need for other interventions to treat epithelial defect
Outcomes
Primary Outcomes
Not specified
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