Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04125394
Recruitment Status : Not yet recruiting
First Posted : October 14, 2019
Last Update Posted : October 14, 2019
Sponsor:
Collaborator:
Hospital Universitario Principe de Asturias
Information provided by (Responsible Party):
Tiedra Farmacéutica SL

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.

Condition or disease Intervention/treatment Phase
Corneal Edema Device: hypertonic Sodium chloride (NaCl 5%) eye drops solution in single-dose Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

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 Name: Ocumax 5 eye drops solution in single-dose




Primary Outcome Measures :
  1. Mean Change from Baseline in Visual acuity [ Time Frame: Baseline, Day 7 and Day 28 ]

Secondary Outcome Measures :
  1. Mean Change from Baseline in Corneal Thickness [ Time Frame: Baseline, Day 7 and Day 28 ]
    Micrometers


Other Outcome Measures:
  1. Number of Participants with Treatment-Related Adverse Events (Objective Tolerance) [ Time Frame: Baseline, Day 7 and Day 28 ]
    Slit Lamp Examination

  2. Score in Subjective Tolerance Test [ Time Frame: Day 7 and Day 28 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04125394


Contacts
Layout table for location contacts
Contact: Tiedra Farmaceutica +34 91 643 41 40 info@tiedra.net

Sponsors and Collaborators
Tiedra Farmacéutica SL
Hospital Universitario Principe de Asturias

Layout table for additonal information
Responsible Party: Tiedra Farmacéutica SL
ClinicalTrials.gov Identifier: NCT04125394    
Other Study ID Numbers: TCL/CSH/022019
First Posted: October 14, 2019    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tiedra Farmacéutica SL:
corneal edema
sodium chloride
single-dose
Additional relevant MeSH terms:
Layout table for MeSH terms
Corneal Edema
Edema
Signs and Symptoms
Corneal Diseases
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions