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Dry EyeNCT03617315

Crosslinked Hyaluronic Acid With Liposomes and Crocin in Dry Eye

A study testing Hylauronic Acid in people with Dry Eye and Meibomian Gland Dysfunction, run by University of Seville at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
What is being tested?
Hylauronic Acid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteSpain
Study dates
1 Oct 2017to 20 Mar 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Ocular Surface Disease Index over 15
  • Dysfunction of the meibomian gland
  • User contact lenses silicone hydrogel
  • User of digital screens for a long timeç

Who cannot join

  • Previous eye surgeries
  • Previous eye pathologies
  • User of artificial tears
  • User of ophthalmic gels

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • José-María Sánchez-González

    Seville, Seville, 41012

Other trials in Spain

About this study

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

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.

Read the 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

Being tested
Hylauronic Acid
Keywords
Crosslinked Hyaluronic Acid, Meibomian Gland Disfunction, Lubricants, Contact Lens, Dry Eye
Medical subject headings
Dry Eye Syndromes, Meibomian Gland Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hylauronic AcidDrug

    Also called Galacto-Xiloglucan, HA+GX

    Schirmer Test, BUT test and OSDI test. Previous and After treatment

Study groups in NCT03617315
Study groupRoleWhat they receive
Hyaluronic AcidExperimentalOne drop application of Hyaluronic acid + Galact-Xyloglucan with a dosage of 3 times a day for 45 days
Receives: Drug: Hylauronic Acid
CrossLinked Hyalurnic AcidExperimentalOne drop application of Crosslinked Hylauronic Acid + Liposomes with a dosage of 3 times a day for 45 days
Receives: Drug: Hylauronic Acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Schirmer Test

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

    Measured: 6 weeks

  2. Break Up Time Test

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

    Measured: 6 weeks

  3. Ocular Surface Disease Index

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

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2018
  2. Study start1 Oct 2017
  3. Primary completion1 Feb 2018
  4. Study completion20 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Contralateral Eye Study
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03617315
Sponsor's protocol ID
HyaluronicAcidClinicalTrial
Status last verified
Aug 2018
First submitted
16 Jul 2018
Last updated
14 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Share with University of Seville Researches through the virtual learning platform

Publications

  • 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.

    PubMed 29189737

  • 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.

    PubMed 23121946

  • 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.

    PubMed 29381080

  • 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.

    PubMed 22813209

  • 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.

    PubMed 28777385

  • 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.

    PubMed 29223649

  • 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.

    PubMed 17394642

  • 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.

    PubMed 24914681

Questions about this trial

What is this clinical trial studying?

A study testing Hylauronic Acid in people with Dry Eye and Meibomian Gland Dysfunction, run by University of Seville at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Schirmer Test (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03617315, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2018.

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