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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.
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 meibografÃa 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyaluronic Acid | Experimental | One drop application of Hyaluronic acid + Galact-Xyloglucan with a dosage of 3 times a day for 45 days |
|
| CrossLinked Hyalurnic Acid | Experimental | One drop application of Crosslinked Hylauronic Acid + Liposomes with a dosage of 3 times a day for 45 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hylauronic Acid | Drug | Schirmer Test, BUT test and OSDI test. Previous and After treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Schirmer Test | Measurement of the tear volume. Scale between 0 and 30 milimeters (mm) Higger is better | 6 weeks |
| Break Up Time Test | Lacrimal rupture time of the lipid layer. Scale between 0 and 25 seconds (s) Higger is better | 6 weeks |
| Ocular Surface Disease Index | Dry Eye Score from Questionnaire. Scale between 0 and 50 points. Higger is worse | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| José-MarÃa Sánchez-González | Seville | Seville | 41012 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29189737 | Result | 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. | |
| 23121946 | Result | 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. |
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Share with University of Seville Researches through the virtual learning platform
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D000080343 | Meibomian Gland Dysfunction |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D005141 | Eyelid Diseases |
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| ID | Term |
|---|---|
| C492074 | poly(vinyl alcohol)-hylauronic acid |
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Contralateral Eye Study
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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
| 29381080 | Result | 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. |
| 22813209 | Result | 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. |
| 28777385 | Result | 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. |
| 29223649 | Result | 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. |
| 17394642 | Result | 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. |
| 24914681 | Result | 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. |