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Crosslinked Hyaluronic Acid With Liposomes and Crocin in Dry Eye

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03617315
Recruitment Status : Completed
First Posted : August 6, 2018
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
José-María Sánchez-González, University of Seville

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 disease Intervention/treatment Phase
Dry Eye Meibomian Gland Dysfunction Dry Eye Syndromes Drug: Hylauronic Acid Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Contralateral 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 : October 1, 2017
Actual Primary Completion Date : February 1, 2018
Actual Study Completion Date : March 20, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/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




Primary Outcome Measures :
  1. Schirmer Test [ Time Frame: 6 weeks ]
    Measurement of the tear volume. Scale between 0 and 30 milimeters (mm) Higger is better

  2. Break Up Time Test [ Time Frame: 6 weeks ]
    Lacrimal rupture time of the lipid layer. Scale between 0 and 25 seconds (s) Higger is better

  3. Ocular Surface Disease Index [ Time Frame: 6 weeks ]
    Dry Eye Score from Questionnaire. Scale between 0 and 50 points. Higger is worse



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03617315


Locations
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Spain
José-María Sánchez-González
Sevilla, Seville, Spain, 41012
Sponsors and Collaborators
University of Seville
Publications of Results:

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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: August 6, 2018    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Share with University of Seville Researches through the virtual learning platform

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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, University of Seville:
Crosslinked Hyaluronic Acid
Meibomian Gland Disfunction
Lubricants
Contact Lens
Dry Eye
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Meibomian Gland Dysfunction
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Eyelid Diseases