Last updated: November 29, 2023
Sponsor: Tecnoquimicas
Overall Status: Active - Recruiting
Phase
N/A
Condition
Sjogren's Syndrome
Dry Eye Disease
Eyelid Inflammation
Treatment
Preservative-free sterile ophthalmic solution, with 0.3% propylene glycol and 0.4% polyethylene glycol (400)
Clinical Study ID
NCT06162442
CEI-001
Ages 18-45 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Ability to sign informed consent.
- Any sex.
- Women of reproductive age should secure a method during the contraceptive study.
- Diagnosis of dry eye (mild, moderate) prior to the study in treatment with lubricantswith preservatives.
Exclusion
Exclusion Criteria:
- Patients with any acquired or congenital anomaly or ocular malformation that preventsan adequate exploration of the ocular surface.
- Patients with a history of ocular surface surgery (cornea and conjunctiva).
- Patients being treated with medications that may compromise the state of the ocularsurface: glaucoma, allergy, scarring diseases.
- Patients with allergy to fluorescein, lissamine green or tetracaine.
- Patients with lacrimal duct obstruction
- Severe dry eye
- Kidney failure
- Liver failure
- Pregnancy
- Breastfeeding
Study Design
Total Participants: 132
Treatment Group(s): 1
Primary Treatment: Preservative-free sterile ophthalmic solution, with 0.3% propylene glycol and 0.4% polyethylene glycol (400)
Phase:
Study Start date:
March 15, 2023
Estimated Completion Date:
April 15, 2024
Study Description
Connect with a study center
Clínica Sigma
Cali, Valle Del Cauca 760044
ColombiaActive - Recruiting
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