Corneal EdemaNCT04125394
Efficacy and Tolerance of Hypertonic Sodium Chloride (NaCl 5%) Eye Drops Without Preservatives in Corneal Edema
A study testing hypertonic Sodium chloride (NaCl 5%) eye drops solution in single-dose in people with Corneal Edema, run by Tiedra Farmacéutica SL at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Edema
- What is being tested?
- hypertonic Sodium chloride (NaCl 5%) eye drops solution in single-dose
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 3 Feb 2021to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Príncipe de Asturias
Alcalá de Henares
Rafael Cañones
About this study
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
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.
- Conditions
- Corneal Edema
- Being tested
- hypertonic Sodium chloride (NaCl 5%) eye drops solution in single-dose
- Keywords
- corneal edema, sodium chloride, single-dose
- Medical subject headings
- Corneal Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypertonic Sodium chloride (NaCl 5%) eye drops solution in single-doseDevice
Also called Ocumax 5 eye drops solution in single-dose
Ophthalmic solution of hypertonic sodium chloride (NaCl 5%) without preservatives in single-dose container
| Study group | Role | What they receive |
|---|---|---|
| NaCl 5% | Experimental | Hypertonic sodium chloride (NaCl 5%) eye drops solution in single-dose, without preservatives, administered every 8 hours for 28 days. Receives: Device: hypertonic Sodium chloride (NaCl 5%) eye drops solution in single-dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change from Baseline in Visual acuity
Measured: Baseline, Day 7 and Day 28
Secondary outcomes (1)
Mean Change from Baseline in Corneal Thickness
Micrometers
Measured: Baseline, Day 7 and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study start3 Feb 2021 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tiedra Farmacéutica SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Universitario Principe de Asturias
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04125394
- Sponsor's protocol ID
- TCL/CSH/022019
- Status last verified
- Oct 2020
- First submitted
- 11 Oct 2019
- Last updated
- 8 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04125394
- Acronym / sponsor ID
- TCL/CSH/022019
- Conditions
- Corneal Edema
- Keywords
- corneal edema, sodium chloride, single-dose
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tiedra Farmacéutica SLIndustry (pharma, biotech, devices)
- Collaborators
- Hospital Universitario Principe de Asturias
- Study start
- 3 Feb 2021 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 14 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NaCl 5% | Experimental | Device: hypertonic Sodium chloride (NaCl 5%) eye drops solution in single-doseHypertonic sodium chloride (NaCl 5%) eye drops solution in single-dose, without preservatives, administered every 8 hours for 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hypertonic Sodium chloride (NaCl 5%) eye drops solution in single-doseAlso: Ocumax 5 eye drops solution in single-doseOphthalmic solution of hypertonic sodium chloride (NaCl 5%) without preservatives in single-dose container | Device | NaCl 5% |
Primary outcome
Mean Change from Baseline in Visual acuity
Time frame: Baseline, Day 7 and Day 28
1 secondary outcome
Mean Change from Baseline in Corneal Thickness
Time frame: Baseline, Day 7 and Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypertonic Sodium chloride (NaCl 5%) eye drops solution in single-dose in people with Corneal Edema, run by Tiedra Farmacéutica SL at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tiedra Farmaceutica (+34 91 643 41 40, info@tiedra.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change from Baseline in Visual acuity (time frame: Baseline, Day 7 and Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020; AzTrials last refreshed its copy on 7 Nov 2026.