PURPOSE: Synergistic interactions between hyaluronic acid (HA) and tamarind seed polysaccharide (TS-polysaccharide) have been demonstrated by means of nuclear magnetic resonance spectroscopy. This study was designed to investigate the potential clinical benefit of a combination of HA and TS-polysaccharide in managing dry eye disease (DED). METHODS: A total of 49 subjects with moderate DED, confirmed by Ocular Surface Disease Index (OSDI) questionnaire score between 10 and 25, tear break-up time (BUT) <10 seconds, or Schirmer I test <5.5 mm after 5 minutes, and lissamine green stainingof the ocular surface >2 according to National Eye Institute score system, were enrolled into this multicenter, randomized, double-masked study to receive either combination of HA and TS-polysaccharide or carmellose sodium for 3 months, both instilled 4 times per day. The assessments included OSDI questionnaire, tear film stability (BUT), tear production (Schirmer I test), and corneal and conjunctival staining. RESULTS: Patients treated with HA and TS-polysaccharide showed a statistically significant improvement in the OSDI score at the end of the study compared to the baseline and control groups. The HA and TS-polysaccharide and carmellose sodium were equally effective in reducing BUT and the extent of injury assessed by corneal and conjunctival staining. Non-significant changes were recorded for Schirmer I test. CONCLUSIONS: Based on the results of this clinical trial, the combination of HA and TS-polysaccharide appears to be effective in improving the symptoms of dry eye, opening new scenarios in possible treatment of the disease by combining different molecules.
RCT Entities:
PURPOSE: Synergistic interactions between hyaluronic acid (HA) and tamarind seed polysaccharide (TS-polysaccharide) have been demonstrated by means of nuclear magnetic resonance spectroscopy. This study was designed to investigate the potential clinical benefit of a combination of HA and TS-polysaccharide in managing dry eye disease (DED). METHODS: A total of 49 subjects with moderate DED, confirmed by Ocular Surface Disease Index (OSDI) questionnaire score between 10 and 25, tear break-up time (BUT) <10 seconds, or Schirmer I test <5.5 mm after 5 minutes, and lissamine green staining of the ocular surface >2 according to National Eye Institute score system, were enrolled into this multicenter, randomized, double-masked study to receive either combination of HA and TS-polysaccharide or carmellose sodium for 3 months, both instilled 4 times per day. The assessments included OSDI questionnaire, tear film stability (BUT), tear production (Schirmer I test), and corneal and conjunctival staining. RESULTS:Patients treated with HA and TS-polysaccharide showed a statistically significant improvement in the OSDI score at the end of the study compared to the baseline and control groups. The HA and TS-polysaccharide and carmellose sodium were equally effective in reducing BUT and the extent of injury assessed by corneal and conjunctival staining. Non-significant changes were recorded for Schirmer I test. CONCLUSIONS: Based on the results of this clinical trial, the combination of HA and TS-polysaccharide appears to be effective in improving the symptoms of dry eye, opening new scenarios in possible treatment of the disease by combining different molecules.
Authors: Monica Alves; Peter Sol Reinach; Jayter Silva Paula; Antonio Augusto Vellasco e Cruz; Leticia Bachette; Jacqueline Faustino; Francisco Penteado Aranha; Afonso Vigorito; Carmino Antonio de Souza; Eduardo Melani Rocha Journal: PLoS One Date: 2014-05-21 Impact factor: 3.240