Crosslinked Hyaluronic Acid With Liposomes and Crocin in Dry Eye

Study Overview
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Brief Summary
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A total of 50 eyes were analyzed (25 patients). The subjects selected were over 18 years of age. No gender distinction was made in the choice of subjects. All subjects were carriers of silicone hydrogel contact lenses. The antecedents of the eye diseases not identified, neither the previous eye surgeries nor the systemic or ocular medication. All patients read, understood and signed an informed consent form of the study.

Detailed Description
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A study was performed using the contralateral eye, the study groups were randomized. The choice of eye for each tear was random and established as an artificial tear A and artificial tear B. The patients were not previously warned about the type of artificial tear they were going to use or the difference that existed between them, therefore, they were unaware of the benefits that such tears could offer them. The examiner did know what tear was applied to each eye. As for the lubricants used; Tear A (Aquoral Forte®, ESTEVE®, Farmigea, Pisa, Italy) was a combination of 0.4% unridged hyaluronic acid and 0.2% Galacto-xyloglucan. The galacto-xyloglucan is extracted from the tamarind seed. It consists of 30 single doses, each with 0.5 ml and have a daily use closure, that is, it can not be used once 12 hours have passed since the dose was opened. This lubricant lacks preservatives. On the other hand, tear B (Aquoral Lipo® [Spain] / Lumixa® [Italy], ESTEVE®, Farmigea, Pisa, Italy) is a combination of three components; cross-linked hyaluronic acid (CXL) at 0.15%, crocin and liposomes. It is an ophthalmic lubricant and antioxidant solution. Its package is 10 ml multidose, so it can be used for a long time. It is composed of liposomes, sodium salt of crosslinked hyaluronic acid 0.15%, ethylenediaminetetraacetic acid (EDTA) disodium salt and crocin. Although this tear comes in a multi-dose container, it does not contain a preservative due to the dispenser that does not let microorganisms from outside. Contact lenses can be used while both lubricants are applied. In this regard, the study patients used their silicone hydrogel contact lenses monthly during the study. All patients in the study had a period of one month without using any type of artificial tear or eye drops. Once this time or study was over, the patients were explained how artificial tears should be instilled. The visits were carried out blindly by research optometrists. Who did not know how the distribution of artificial tears in patients had been. The artificial tears were administered 3 times a day for 6 weeks and the subjects belonging to the study underwent a clinical examination in the period prior to treatment and 45 days after the treatment, once the treatment with artificial tears. He was repeated the tests of the beginning, nevertheless, the meibografía was not realized, since the use of artificial tears was not going to cause the growth of the glands of Meibomio

Official Title
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Crosslinked Hyaluronic Acid With Liposomes and Crocin in the Treatment of Dry Eye Disease Due to Moderate Meibomian Glands Dysfunction

Conditions
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Dry Eye, Meibomian Gland Dysfunction, Dry Eye Syndromes

Intervention / Treatment
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* Drug: Hylauronic Acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ocular Surface Disease Index over 15 Dysfunction of the meibomian gland User contact lenses silicone hydrogel User of digital screens for a long timeç Exclusion Criteria: Previous eye surgeries Previous eye pathologies User of artificial tears User of ophthalmic gels

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Contralateral Eye Study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyaluronic Acid<br>One drop application of Hyaluronic acid + Galact-Xyloglucan with a dosage of 3 times a day for 45 days | Drug: Hylauronic Acid<br>* Schirmer Test, BUT test and OSDI test. Previous and After treatment<br>* Other names: HA+GX;|
| Experimental: CrossLinked Hyalurnic Acid<br>One drop application of Crosslinked Hylauronic Acid + Liposomes with a dosage of 3 times a day for 45 days | Drug: Hylauronic Acid<br>* Schirmer Test, BUT test and OSDI test. Previous and After treatment<br>* Other names: HA+GX;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Schirmer Test | Measurement of the tear volume. Scale between 0 and 30 milimeters (mm) Higger is better | 6 weeks | 
| Break Up Time Test | Lacrimal rupture time of the lipid layer. Scale between 0 and 25 seconds (s) Higger is better | 6 weeks | 
| Ocular Surface Disease Index | Dry Eye Score from Questionnaire. Scale between 0 and 50 points. Higger is worse | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crosslinked Hyaluronic Acid, Meibomian Gland Disfunction, Lubricants, Contact Lens, Dry Eye