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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-03

Study Completion Date

2021-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Corneal Edema

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NaCl 5%

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

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

Ophthalmic solution of hypertonic sodium chloride (NaCl 5%) without preservatives in single-dose container

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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Ocumax 5 eye drops solution in single-dose

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No