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Crosslinked Hyaluronic Acid With Liposomes and Crocin in Dry Eye

Primary Purpose

Dry Eye, Meibomian Gland Dysfunction, Dry Eye Syndromes

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Hylauronic Acid
Sponsored by
University of Seville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye focused on measuring Crosslinked Hyaluronic Acid, Meibomian Gland Disfunction, Lubricants, Contact Lens, Dry Eye

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • José-María Sánchez-González

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Hyaluronic Acid

CrossLinked Hyalurnic Acid

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 16, 2018
Last Updated
August 10, 2018
Sponsor
University of Seville
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1. Study Identification

Unique Protocol Identification Number
NCT03617315
Brief Title
Crosslinked Hyaluronic Acid With Liposomes and Crocin in Dry Eye
Official Title
Crosslinked Hyaluronic Acid With Liposomes and Crocin in the Treatment of Dry Eye Disease Due to Moderate Meibomian Glands Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
February 1, 2018 (Actual)
Study Completion Date
March 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Seville

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye, Meibomian Gland Dysfunction, Dry Eye Syndromes
Keywords
Crosslinked Hyaluronic Acid, Meibomian Gland Disfunction, Lubricants, Contact Lens, Dry Eye

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Contralateral Eye Study
Masking
ParticipantOutcomes 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
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hyaluronic Acid
Arm Type
Experimental
Arm Description
One drop application of Hyaluronic acid + Galact-Xyloglucan with a dosage of 3 times a day for 45 days
Arm Title
CrossLinked Hyalurnic Acid
Arm Type
Experimental
Arm Description
One drop application of Crosslinked Hylauronic Acid + Liposomes with a dosage of 3 times a day for 45 days
Intervention Type
Drug
Intervention Name(s)
Hylauronic Acid
Other Intervention Name(s)
Galacto-Xiloglucan, HA+GX
Intervention Description
Schirmer Test, BUT test and OSDI test. Previous and After treatment
Primary Outcome Measure Information:
Title
Schirmer Test
Description
Measurement of the tear volume. Scale between 0 and 30 milimeters (mm) Higger is better
Time Frame
6 weeks
Title
Break Up Time Test
Description
Lacrimal rupture time of the lipid layer. Scale between 0 and 25 seconds (s) Higger is better
Time Frame
6 weeks
Title
Ocular Surface Disease Index
Description
Dry Eye Score from Questionnaire. Scale between 0 and 50 points. Higger is worse
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
José-María Sánchez-González
City
Sevilla
State/Province
Seville
ZIP/Postal Code
41012
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Share with University of Seville Researches through the virtual learning platform
Citations:
PubMed Identifier
29189737
Citation
Fallacara A, Vertuani S, Panozzo G, Pecorelli A, Valacchi G, Manfredini S. Novel Artificial Tears Containing Cross-Linked Hyaluronic Acid: An In Vitro Re-Epithelialization Study. Molecules. 2017 Nov 30;22(12):2104. doi: 10.3390/molecules22122104.
Results Reference
result
PubMed Identifier
23121946
Citation
Uccello-Barretta G, Balzano F, Vanni L, Sanso M. Mucoadhesive properties of tamarind-seed polysaccharide/hyaluronic acid mixtures: A nuclear magnetic resonance spectroscopy investigation. Carbohydr Polym. 2013 Jan 16;91(2):568-72. doi: 10.1016/j.carbpol.2012.07.085. Epub 2012 Aug 25.
Results Reference
result
PubMed Identifier
29381080
Citation
Doan S, Bremond-Gignac D, Chiambaretta F. Comparison of the effect of a hyaluronate-trehalose solution to hyaluronate alone on Ocular Surface Disease Index in patients with moderate to severe dry eye disease. Curr Med Res Opin. 2018 Aug;34(8):1373-1376. doi: 10.1080/03007995.2018.1434496. Epub 2018 Feb 7.
Results Reference
result
PubMed Identifier
22813209
Citation
Jacobi C, Kruse FE, Cursiefen C. Prospective, randomized, controlled comparison of SYSTANE UD eye drops versus VISINE INTENSIV 1% EDO eye drops for the treatment of moderate dry eye. J Ocul Pharmacol Ther. 2012 Dec;28(6):598-603. doi: 10.1089/jop.2012.0066. Epub 2012 Jul 19.
Results Reference
result
PubMed Identifier
28777385
Citation
Postorino EI, Rania L, Aragona E, Mannucci C, Alibrandi A, Calapai G, Puzzolo D, Aragona P. Efficacy of eyedrops containing cross-linked hyaluronic acid and coenzyme Q10 in treating patients with mild to moderate dry eye. Eur J Ophthalmol. 2018 Jan;28(1):25-31. doi: 10.5301/ejo.5001011. Epub 2018 Feb 19.
Results Reference
result
PubMed Identifier
29223649
Citation
Acar D, Molina-Martinez IT, Gomez-Ballesteros M, Guzman-Navarro M, Benitez-Del-Castillo JM, Herrero-Vanrell R. Novel liposome-based and in situ gelling artificial tear formulation for dry eye disease treatment. Cont Lens Anterior Eye. 2018 Feb;41(1):93-96. doi: 10.1016/j.clae.2017.11.004. Epub 2017 Dec 6.
Results Reference
result
PubMed Identifier
17394642
Citation
Rolando M, Valente C. Establishing the tolerability and performance of tamarind seed polysaccharide (TSP) in treating dry eye syndrome: results of a clinical study. BMC Ophthalmol. 2007 Mar 29;7:5. doi: 10.1186/1471-2415-7-5.
Results Reference
result
PubMed Identifier
24914681
Citation
Williams DL, Mann BK. Efficacy of a crosslinked hyaluronic acid-based hydrogel as a tear film supplement: a masked controlled study. PLoS One. 2014 Jun 10;9(6):e99766. doi: 10.1371/journal.pone.0099766. eCollection 2014.
Results Reference
result

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Crosslinked Hyaluronic Acid With Liposomes and Crocin in Dry Eye

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