Crosslinked Hyaluronic Acid With Liposomes and Crocin in Dry Eye
Condition: Dry Eye; Meibomian Gland Dysfunction; Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Meibomian Gland Dysfunction
Study type: Interventional

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
    

Intervention name(s): Hylauronic Acid
Intervention type(s): Drug
Intervention description(s): Schirmer Test, BUT test and OSDI test. Previous and After treatment
Other intervention name(s): Galacto-Xiloglucan; HA+GX
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Contralateral Eye Study
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Crosslinked Hyaluronic Acid; Meibomian Gland Disfunction; Lubricants; Contact Lens; Dry Eye