Crosslinked Hyaluronic Acid With Liposomes and Crocin in Dry Eye

Sponsor
University of Seville (Other)
Overall Status
Completed
CT.gov ID
NCT03617315
Collaborator
(none)
25
Enrollment
1
Location
2
Arms
5.6
Actual Duration (Months)
4.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Hylauronic Acid
N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Contralateral Eye StudyContralateral Eye Study
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
The patients did not know the artificial tear that should be applied. The researcher in charge of processing the results and drawing the conclusions did not know the name of the artificial tears
Primary Purpose:
Treatment
Official Title:
Crosslinked Hyaluronic Acid With Liposomes and Crocin in the Treatment of Dry Eye Disease Due to Moderate Meibomian Glands Dysfunction
Actual Study Start Date :
Oct 1, 2017
Actual Primary Completion Date :
Feb 1, 2018
Actual Study Completion Date :
Mar 20, 2018

Arms and Interventions

ArmIntervention/Treatment
Experimental: Hyaluronic Acid

One drop application of Hyaluronic acid + Galact-Xyloglucan with a dosage of 3 times a day for 45 days

Drug: Hylauronic Acid
Schirmer Test, BUT test and OSDI test. Previous and After treatment
Other Names:
  • Galacto-Xiloglucan
  • HA+GX
  • Experimental: CrossLinked Hyalurnic Acid

    One drop application of Crosslinked Hylauronic Acid + Liposomes with a dosage of 3 times a day for 45 days

    Drug: Hylauronic Acid
    Schirmer Test, BUT test and OSDI test. Previous and After treatment
    Other Names:
  • Galacto-Xiloglucan
  • HA+GX
  • Outcome Measures

    Primary Outcome Measures

    1. Schirmer Test [6 weeks]

      Measurement of the tear volume. Scale between 0 and 30 milimeters (mm) Higger is better

    2. Break Up Time Test [6 weeks]

      Lacrimal rupture time of the lipid layer. Scale between 0 and 25 seconds (s) Higger is better

    3. Ocular Surface Disease Index [6 weeks]

      Dry Eye Score from Questionnaire. Scale between 0 and 50 points. Higger is worse

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 30 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1José-María Sánchez-GonzálezSevillaSevilleSpain41012

    Sponsors and Collaborators

    • University of Seville

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    José-María Sánchez-González, PhD Optometry and Vision Science, University of Seville
    ClinicalTrials.gov Identifier:
    NCT03617315
    Other Study ID Numbers:
    • HyaluronicAcidClinicalTrial
    First Posted:
    Aug 6, 2018
    Last Update Posted:
    Aug 14, 2018
    Last Verified:
    Aug 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by José-María Sánchez-González, PhD Optometry and Vision Science, University of Seville
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 14, 2018