Clinical trial NCT03617315: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Meibomian Gland Dysfunction
Dry Eye Syndromes
Keywords: Crosslinked Hyaluronic Acid
Meibomian Gland Disfunction
Lubricants
Contact Lens
Dry Eye
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2018-08-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Contralateral Eye Study
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Schirmer Test
timeFrame: 6 weeks
measure: Break Up Time Test
timeFrame: 6 weeks
measure: Ocular Surface Disease Index
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: José-María Sánchez-González
state: Seville
Study officials:
References:
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