Efficacy and Tolerance of Hypertonic Sodium Chloride (NaCl 5%) Eye Drops Without Preservatives in Corneal Edema

Corneal Edema Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04125394
• Other study ID #: TCL/CSH/022019
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 3, 2021
• Est. completion date: June 2021

Study information

• Verified date: October 2020
• Source: Tiedra Farmacéutica SL
• Contact: Tiedra Farmaceutica
• Phone: +34 91 643 41 40
• Email: info[@]tiedra.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Corneal Edema
• Edema

Intervention

Device:
• hypertonic Sodium chloride (NaCl 5%) eye drops solution in single-dose
Ophthalmic solution of hypertonic sodium chloride (NaCl 5%) without preservatives in single-dose container

Locations

Country	Name	City	State
Spain	Hospital Universitario Príncipe de Asturias	Alcalá De Henares

Sponsors (2)

Lead Sponsor	Collaborator
Tiedra Farmacéutica SL	Hospital Universitario Principe de Asturias

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants with Treatment-Related Adverse Events (Objective Tolerance)	Slit Lamp Examination	Baseline, Day 7 and Day 28
Other	Score in Subjective Tolerance Test		Day 7 and Day 28
Primary	Mean Change from Baseline in Visual acuity		Baseline, Day 7 and Day 28
Secondary	Mean Change from Baseline in Corneal Thickness	Micrometers	Baseline, Day 7 and Day 28