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

T

Tiedra Farmacéutica

Status

Unknown

Conditions

Corneal Edema

Treatments

Device: hypertonic Sodium chloride (NaCl 5%) eye drops solution in single-dose

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04125394
TCL/CSH/022019

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

NaCl 5%
Experimental group
Description:
Hypertonic sodium chloride (NaCl 5%) eye drops solution in single-dose, without preservatives, administered every 8 hours for 28 days.
Treatment:
Device: hypertonic Sodium chloride (NaCl 5%) eye drops solution in single-dose

Trial contacts and locations

1

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Central trial contact

Tiedra Farmaceutica

Data sourced from clinicaltrials.gov

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