Efficacy and Tolerance of Hypertonic Sodium Chloride (NaCl 5%) Eye Drops Without Preservatives in Corneal Edema
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
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2019
CompletedFirst Posted
Study publicly available on registry
October 14, 2019
CompletedStudy Start
First participant enrolled
February 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedOctober 8, 2020
October 1, 2020
3 months
October 11, 2019
October 5, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change from Baseline in Visual acuity
Baseline, Day 7 and Day 28
Secondary Outcomes (1)
Mean Change from Baseline in Corneal Thickness
Baseline, Day 7 and Day 28
Other Outcomes (2)
Number of Participants with Treatment-Related Adverse Events (Objective Tolerance)
Baseline, Day 7 and Day 28
Score in Subjective Tolerance Test
Day 7 and Day 28
Study Arms (1)
NaCl 5%
EXPERIMENTALHypertonic sodium chloride (NaCl 5%) eye drops solution in single-dose, without preservatives, administered every 8 hours for 28 days.
Interventions
Ophthalmic solution of hypertonic sodium chloride (NaCl 5%) without preservatives in single-dose container
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitario Príncipe de Asturias
Alcalá de Henares, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2019
First Posted
October 14, 2019
Study Start
February 3, 2021
Primary Completion
May 1, 2021
Study Completion
June 1, 2021
Last Updated
October 8, 2020
Record last verified: 2020-10