Status:
UNKNOWN
Efficacy and Tolerance of Hypertonic Sodium Chloride (NaCl 5%) Eye Drops Without Preservatives in Corneal Edema
Lead Sponsor:
Tiedra Farmacéutica SL
Collaborating Sponsors:
Hospital Universitario Principe de Asturias
Conditions:
Corneal Edema
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Corneal edema is frequently found in clinical practice as a common sign of acute corneal disease due to different etiologies that cause an accumulation of extracellular fluid in the cornea. The presen...
Eligibility Criteria
Inclusion
- Age over 18 years
- Clinical diagnosis of symptomatic corneal edema related to chronic epithelial, secondary to corneal dystrophies, controlled infectious and inflammatory pathologies and surgical trauma already resolved.
- No need for keratoplasty in the 6 months following the start of the study
Exclusion
- .
- Visual acuity less than 1/20 in both eyes
- Corneal edema caused by the following acute etiologies: trauma, infection, inflammation or Stevens-Johnson syndrome.
- Glaucoma or uncontrolled hypertension.
- Known allergy to any of the ingredients of the product.
Key Trial Info
Start Date :
February 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04125394
Start Date
February 3 2021
End Date
June 1 2021
Last Update
October 8 2020
Active Locations (1)
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1
Hospital Universitario Príncipe de Asturias
Alcalá de Henares, Spain