Crosslinked Hyaluronic Acid With Liposomes and Crocin in Dry Eye
- Conditions
- Meibomian Gland DysfunctionDry Eye SyndromesDry Eye
- Interventions
- Drug: Hylauronic Acid
- Registration Number
- NCT03617315
- Lead Sponsor
- 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.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- Ocular Surface Disease Index over 15
- Dysfunction of the meibomian gland
- User contact lenses silicone hydrogel
- User of digital screens for a long timeç
- Previous eye surgeries
- Previous eye pathologies
- User of artificial tears
- User of ophthalmic gels
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hyaluronic Acid Hylauronic Acid One drop application of Hyaluronic acid + Galact-Xyloglucan with a dosage of 3 times a day for 45 days CrossLinked Hyalurnic Acid Hylauronic Acid One drop application of Crosslinked Hylauronic Acid + Liposomes with a dosage of 3 times a day for 45 days
- Primary Outcome Measures
Name Time Method Schirmer Test 6 weeks Measurement of the tear volume. Scale between 0 and 30 milimeters (mm) Higger is better
Break Up Time Test 6 weeks Lacrimal rupture time of the lipid layer. Scale between 0 and 25 seconds (s) Higger is better
Ocular Surface Disease Index 6 weeks Dry Eye Score from Questionnaire. Scale between 0 and 50 points. Higger is worse
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
José-María Sánchez-González
🇪🇸Sevilla, Seville, Spain