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Status unknownNCT04125394Updated Oct 8, 2020

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

An interventional study of hypertonic Sodium chloride (NaCl 5%) eye drops solution in single-dose in Corneal Edema, sponsored by Tiedra Farmacéutica SL. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-08.

Sponsored by Tiedra Farmacéutica SL · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Corneal Edema

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Keywords

  • corneal edema
  • sodium chloride
  • single-dose
03

In context

Corneal Edema

45 studies on the registry are indexed under Corneal Edema; 7 are open to participants now.

This study's planned enrollment of 30 is below the median of 42 across 37 interventional studies indexed under Corneal Edema.

Browse Corneal Edema studies →

Lead sponsor

This is the only study on the registry with Tiedra Farmacéutica SL as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    NaCl 5%

    Hypertonic sodium chloride (NaCl 5%) eye drops solution in single-dose, without preservatives, administered every 8 hours for 28 days.

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

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

    Also known as: Ocumax 5 eye drops solution in single-dose

06

What researchers measure

Primary outcomes

  1. Mean Change from Baseline in Visual acuity

    Time frame: Baseline, Day 7 and Day 28

Secondary outcomes

  1. Mean Change from Baseline in Corneal Thickness

    Micrometers

    Time frame: Baseline, Day 7 and Day 28

Other outcomes

  1. Number of Participants with Treatment-Related Adverse Events (Objective Tolerance)

    Slit Lamp Examination

    Time frame: Baseline, Day 7 and Day 28

  2. Score in Subjective Tolerance Test

    Time frame: Day 7 and Day 28

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Study locations

1 site
  • Hospital Universitario Príncipe de Asturias
    Alcalá De Henares, Spain
    • Rafael Cañones · Contact
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 8, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04125394
Lead sponsor
Tiedra Farmacéutica SL
Collaborators
Hospital Universitario Principe de Asturias
Responsible party
Sponsor
First posted
Oct 14, 2019
Start date
Feb 3, 2021 (estimated)
Primary completion
May 2021 (estimated)
Completion
Jun 2021 (estimated)
Last update
Oct 8, 2020

Study contacts

Tiedra Farmaceutica
Contact
info@tiedra.net
+34 91 643 41 40

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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