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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04125394

Enrollment

Registered

2019-10-14

Start date

2021-02-03

Completion date

2021-06-30

Last updated

2020-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Edema

Keywords

corneal edema, sodium chloride, single-dose

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.

Interventions

DEVICEhypertonic Sodium chloride (NaCl 5%) eye drops solution in single-dose

Ophthalmic solution of hypertonic sodium chloride (NaCl 5%) without preservatives in single-dose container

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Mean Change from Baseline in Visual acuity	Baseline, Day 7 and Day 28

Secondary

Measure	Time frame	Description
Mean Change from Baseline in Corneal Thickness	Baseline, Day 7 and Day 28	Micrometers

Other

Measure	Time frame	Description
Number of Participants with Treatment-Related Adverse Events (Objective Tolerance)	Baseline, Day 7 and Day 28	Slit Lamp Examination
Score in Subjective Tolerance Test	Day 7 and Day 28	—

Countries

Spain

Contacts

Primary ContactTiedra Farmaceutica

info@tiedra.net+34 91 643 41 40

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026