Back to resultsEfficacy and Tolerance of Hypertonic Sodium Chloride (NaCl 5%) Eye Drops Without Preservatives in Corneal Edema
Primary Purpose
Corneal Edema
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
hypertonic Sodium chloride (NaCl 5%) eye drops solution in single-dose
Sponsored by
About this trial
This is an interventional treatment trial for Corneal Edema focused on measuring corneal edema, sodium chloride, single-dose
Eligibility Criteria
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.
Sites / Locations
- Hospital Universitario Príncipe de Asturias
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NaCl 5%
Arm Description
Hypertonic sodium chloride (NaCl 5%) eye drops solution in single-dose, without preservatives, administered every 8 hours for 28 days.
Outcomes
Primary Outcome Measures
Mean Change from Baseline in Visual acuity
Secondary Outcome Measures
Mean Change from Baseline in Corneal Thickness
Micrometers
Full Information
NCT ID
NCT04125394
First Posted
October 11, 2019
Last Updated
October 5, 2020
Sponsor
Tiedra Farmacéutica SL
Collaborators
Hospital Universitario Principe de Asturias
1. Study Identification
Unique Protocol Identification Number
NCT04125394
Brief Title
Efficacy and Tolerance of Hypertonic Sodium Chloride (NaCl 5%) Eye Drops Without Preservatives in Corneal Edema
Official Title
Unicentric Clinical Trial on the Clinical Efficacy and Tolerance of the Treatment With an Ophthalmic Solution of Hypertonic Sodium Chloride (NaCl 5%) Without Preservatives in Patients Suffering From Symptomatic Corneal Edema
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 3, 2021 (Anticipated)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tiedra Farmacéutica SL
Collaborators
Hospital Universitario Principe de Asturias
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Edema
Keywords
corneal edema, sodium chloride, single-dose
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NaCl 5%
Arm Type
Experimental
Arm Description
Hypertonic sodium chloride (NaCl 5%) eye drops solution in single-dose, without preservatives, administered every 8 hours for 28 days.
Intervention Type
Device
Intervention Name(s)
hypertonic Sodium chloride (NaCl 5%) eye drops solution in single-dose
Other Intervention Name(s)
Ocumax 5 eye drops solution in single-dose
Intervention Description
Ophthalmic solution of hypertonic sodium chloride (NaCl 5%) without preservatives in single-dose container
Primary Outcome Measure Information:
Title
Mean Change from Baseline in Visual acuity
Time Frame
Baseline, Day 7 and Day 28
Secondary Outcome Measure Information:
Title
Mean Change from Baseline in Corneal Thickness
Description
Micrometers
Time Frame
Baseline, Day 7 and Day 28
Other Pre-specified Outcome Measures:
Title
Number of Participants with Treatment-Related Adverse Events (Objective Tolerance)
Description
Slit Lamp Examination
Time Frame
Baseline, Day 7 and Day 28
Title
Score in Subjective Tolerance Test
Time Frame
Day 7 and Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tiedra Farmaceutica
Phone
+34 91 643 41 40
Email
info@tiedra.net
Facility Information:
Facility Name
Hospital Universitario Príncipe de Asturias
City
Alcalá De Henares
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafael Cañones
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efficacy and Tolerance of Hypertonic Sodium Chloride (NaCl 5%) Eye Drops Without Preservatives in Corneal Edema
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