Efficacy and Tolerance of Hypertonic Sodium Chloride (NaCl 5%) Eye Drops Without Preservatives in Corneal Edema
Not Applicable
- Conditions
- Corneal Edema
- Interventions
- Device: hypertonic Sodium chloride (NaCl 5%) eye drops solution in single-dose
- Registration Number
- NCT04125394
- Lead Sponsor
- Tiedra Farmacéutica SL
- 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 present unicentric clinical trial aims to evaluate the efficacy and tolerance of an ophthalmic solution of hypertonic sodium chloride (NaCl 5%) without preservatives in participants suffering from symptomatic corneal edema.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- 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 Criteria
.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description NaCl 5% hypertonic Sodium chloride (NaCl 5%) eye drops solution in single-dose Hypertonic sodium chloride (NaCl 5%) eye drops solution in single-dose, without preservatives, administered every 8 hours for 28 days.
- Primary Outcome Measures
Name Time Method Mean Change from Baseline in Visual acuity Baseline, Day 7 and Day 28
- Secondary Outcome Measures
Name Time Method Mean Change from Baseline in Corneal Thickness Baseline, Day 7 and Day 28 Micrometers
Trial Locations
- Locations (1)
Hospital Universitario Príncipe de Asturias
🇪🇸Alcalá De Henares, Spain