Clinical trial • Phase II | Phase IV • Ophthalmology

FIBRIN MATRIX for Glaucoma

Phase II | Phase IV trial of FIBRIN MATRIX for Glaucoma. open-label, none/not specified-controlled. 30 participants.

Overview

open-label, none/not specified-controlled Phase II | Phase IV trial across 1 site in Spain.

Recruits 30 No vulnerable populations selected. Adults only; participants must give consent to participate in the study..

Pregnancy Exclusion: Women of childbearing age with pregnancy intention, pregnant women, and breastfeeding women.
Vulnerable Population: No vulnerable populations selected. Adults only; participants must give consent to participate in the study.

{"criterion_text":"- Adult patients diagnosed with glaucoma who are undergoing treatment with at least two ocular hypotensive drugs (3 drops/day) without preservatives for a minimum of the last two years and who consent to participate in the study."}

{"criterion_text":"- Ocular surface pathology other than toxicity due to ocular hypotensive drugs."}
{"criterion_text":"- Previous ocular surface surgeries."}
{"criterion_text":"- Treatment with topical blood derivatives in the last 6 months."}
{"criterion_text":"- Women of childbearing age with pregnancy intention, pregnant women, and breastfeeding women."}
{"criterion_text":"- Allergy to local anesthetics."}

{"endpoint_text":"- Tear Osmolarity: It will be measured using the Tearlab® system (a painless collection of a 30-nanoliter tear sample using a microchip with immediate results). The difference in tear osmolarity between V0 and V2 will be evaluated. Tear osmolarity has been selected as the primary variable of the study because its increase (hyperosmolarity) has been shown to be the best standalone clinical sign for diagnosing ocular surface pathology.","definition_or_measurement_approach":"Measured using the Tearlab® system (30-nanoliter tear sample via microchip with immediate results). The study will evaluate the difference in tear osmolarity between V0 (baseline) and V2."}

Planned Sample Size: 30
Recruitment Window Months: 12
Consent Approach: Participants must give informed consent to participate. Subject information and informed consent form available (document L1_SIS and ICF pub). No details on assent or available languages provided in the record.

Full Name: Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
Organisation Type: Hospital/Clinic/Other health care facility
Country Of Registered Address: Spain

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