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

October 5, 2020 updated by: Tiedra Farmacéutica SL

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Tiedra Farmaceutica
  • Phone Number: +34 91 643 41 40
  • Email: info@tiedra.net

Study Locations

  • Spain
      • Alcalá De Henares, Spain
        • Hospital Universitario Príncipe de Asturias
        • Contact:
          • Rafael Cañones

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Ophthalmic solution of hypertonic sodium chloride (NaCl 5%) without preservatives in single-dose container
Other Names:
  • Ocumax 5 eye drops solution in single-dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean Change from Baseline in Visual acuity
Time Frame: Baseline, Day 7 and Day 28
Baseline, Day 7 and Day 28

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tiedra Farmacéutica SL

Collaborators

Hospital Universitario Principe de Asturias

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 3, 2021

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

October 11, 2019

First Submitted That Met QC Criteria

October 11, 2019

First Posted (Actual)

October 14, 2019

Study Record Updates

Last Update Posted (Actual)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 5, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCL/CSH/022019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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