Crosslinked Hyaluronic Acid With Liposomes and Crocin in Dry Eye

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03617315
• Other study ID #: HyaluronicAcidClinicalTrial
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: March 20, 2018

Study information

• Verified date: August 2018
• Source: University of Seville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 20, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Meibomian Gland Dysfunction

Intervention

Drug:
• Hylauronic Acid
Schirmer Test, BUT test and OSDI test. Previous and After treatment

Locations

Country	Name	City	State
Spain	José-María Sánchez-González	Sevilla	Seville

Sponsors (1)

Lead Sponsor	Collaborator
University of Seville

Country where clinical trial is conducted

Spain, 

References & Publications (8)

Acar D, Molina-Martínez IT, Gómez-Ballesteros M, Guzmán-Navarro M, Benítez-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 — View 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. d — View 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). pii: E2104. doi: 10.3390/molecules22122104. — View 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.2012.006 — View 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): — View 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. — View Citation

Uccello-Barretta G, Balzano F, Vanni L, Sansò 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.2 — View 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. — View Citation

Outcome

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