Prospective, Randomized, Single Masked, Parallel Study Exploring the Effects of a Preservative-Free Ophthalmic Solution Containing Hyaluronic Acid 0.4% and Taurine 0.5% on the Ocular Surface of Glaucoma Patients Under Multiple Long-Term Topical Hypotensive Therapy

Gloria Roberti, Luca Agnifili, Francesca Berardo, Ivano Riva, Michele Figus, Gianluca Manni, Luciano Quaranta, Francesco Oddone

Research output: Contribution to journalArticle

Abstract

Introduction: To compare the effects of a preservative-free (PF) ophthalmic solution containing hyaluronic acid (HA) 0.4% and taurine (TAU) 0.5% with those of a PF ophthalmic solution containing HA 0.2% on ocular surface signs, symptoms, and morphological parameters in glaucoma patients under multiple long-term topical hypotensive therapy. Methods: Eligible patients underwent evaluation of ocular surface parameters by ocular surface disease index (OSDI) and glaucoma symptom scale (GSS) questionnaires, breakup time test (BUT), Schirmer I test, corneal and conjunctival staining (Oxford scale), and conjunctival in vivo confocal microscopy (Heidelberg Retina Tomograph 3, Heidelberg Engineering GmbH, Heidelberg, Germany). After the baseline visit, patients were randomized to use a PF ophthalmic solution containing HA 0.4% and TAU 0.5%, QID, in both eyes (group 1) or to use a PF ophthalmic solution containing HA 0.2%, QID (group 2) in addition to the ongoing preserved hypotensive treatment. Follow-up visits were scheduled at 30 and 90 days. Results: Thirty-nine eyes of 39 glaucoma patients were included in the study. At baseline, results of study tests of both groups were similar. After 90 days in group 1 the BUT (p = 0.01), the Oxford score (p = 0.03), the conjunctival goblet cells (CGC) density (p = 0.0005) ,and the two questionnaires score significantly improved (OSDI, p = 0.003; GSS, p = 0.003) compared to baseline values, while in group 2 all these parameters did not differ from baseline (BUT, p = 0.39; Oxford score, p = 0.54; CGC density, p = 0.33, OSDI p = 0.65, GSS, p = 0.25). The BUT and the CGC density were statistically different between groups both at 30 and 90 days (p = 0.04 and p = 0.04, respectively). The Schirmer I test did not statistically change after 90 days in both groups. Conclusions: The PF ophthalmic solution with HA 0.4% and TAU 0.5% seems to improve CGC density and reduce signs and symptoms of dry eye in glaucoma patients under long-term multiple preserved hypotensive therapy. Trial registration: ClinicalTrials.gov identifier, NCT03480295.

Original languageEnglish
Pages (from-to)686-696
Number of pages11
JournalAdvances in Therapy
Volume35
Issue number5
DOIs
Publication statusPublished - May 1 2018

Fingerprint

Single-Blind Method
Ophthalmic Solutions
Taurine
Hyaluronic Acid
Glaucoma
Goblet Cells
Eye Diseases
Cell Count
Signs and Symptoms
Therapeutics
Confocal Microscopy
Germany
Retina
Staining and Labeling

Keywords

  • Conjunctival goblet cells
  • Glaucoma
  • Hyaluronic acid
  • In vivo confocal microscopy
  • Ophthalmology
  • Taurine

ASJC Scopus subject areas

  • Pharmacology (medical)

Cite this

@article{8997689fe09d41f7bea1c7e3befa2a64,
title = "Prospective, Randomized, Single Masked, Parallel Study Exploring the Effects of a Preservative-Free Ophthalmic Solution Containing Hyaluronic Acid 0.4{\%} and Taurine 0.5{\%} on the Ocular Surface of Glaucoma Patients Under Multiple Long-Term Topical Hypotensive Therapy",
abstract = "Introduction: To compare the effects of a preservative-free (PF) ophthalmic solution containing hyaluronic acid (HA) 0.4{\%} and taurine (TAU) 0.5{\%} with those of a PF ophthalmic solution containing HA 0.2{\%} on ocular surface signs, symptoms, and morphological parameters in glaucoma patients under multiple long-term topical hypotensive therapy. Methods: Eligible patients underwent evaluation of ocular surface parameters by ocular surface disease index (OSDI) and glaucoma symptom scale (GSS) questionnaires, breakup time test (BUT), Schirmer I test, corneal and conjunctival staining (Oxford scale), and conjunctival in vivo confocal microscopy (Heidelberg Retina Tomograph 3, Heidelberg Engineering GmbH, Heidelberg, Germany). After the baseline visit, patients were randomized to use a PF ophthalmic solution containing HA 0.4{\%} and TAU 0.5{\%}, QID, in both eyes (group 1) or to use a PF ophthalmic solution containing HA 0.2{\%}, QID (group 2) in addition to the ongoing preserved hypotensive treatment. Follow-up visits were scheduled at 30 and 90 days. Results: Thirty-nine eyes of 39 glaucoma patients were included in the study. At baseline, results of study tests of both groups were similar. After 90 days in group 1 the BUT (p = 0.01), the Oxford score (p = 0.03), the conjunctival goblet cells (CGC) density (p = 0.0005) ,and the two questionnaires score significantly improved (OSDI, p = 0.003; GSS, p = 0.003) compared to baseline values, while in group 2 all these parameters did not differ from baseline (BUT, p = 0.39; Oxford score, p = 0.54; CGC density, p = 0.33, OSDI p = 0.65, GSS, p = 0.25). The BUT and the CGC density were statistically different between groups both at 30 and 90 days (p = 0.04 and p = 0.04, respectively). The Schirmer I test did not statistically change after 90 days in both groups. Conclusions: The PF ophthalmic solution with HA 0.4{\%} and TAU 0.5{\%} seems to improve CGC density and reduce signs and symptoms of dry eye in glaucoma patients under long-term multiple preserved hypotensive therapy. Trial registration: ClinicalTrials.gov identifier, NCT03480295.",
keywords = "Conjunctival goblet cells, Glaucoma, Hyaluronic acid, In vivo confocal microscopy, Ophthalmology, Taurine",
author = "Gloria Roberti and Luca Agnifili and Francesca Berardo and Ivano Riva and Michele Figus and Gianluca Manni and Luciano Quaranta and Francesco Oddone",
year = "2018",
month = "5",
day = "1",
doi = "10.1007/s12325-018-0699-8",
language = "English",
volume = "35",
pages = "686--696",
journal = "Advances in Therapy",
issn = "0741-238X",
publisher = "Springer Healthcare",
number = "5",

}

TY - JOUR

T1 - Prospective, Randomized, Single Masked, Parallel Study Exploring the Effects of a Preservative-Free Ophthalmic Solution Containing Hyaluronic Acid 0.4% and Taurine 0.5% on the Ocular Surface of Glaucoma Patients Under Multiple Long-Term Topical Hypotensive Therapy

AU - Roberti, Gloria

AU - Agnifili, Luca

AU - Berardo, Francesca

AU - Riva, Ivano

AU - Figus, Michele

AU - Manni, Gianluca

AU - Quaranta, Luciano

AU - Oddone, Francesco

PY - 2018/5/1

Y1 - 2018/5/1

N2 - Introduction: To compare the effects of a preservative-free (PF) ophthalmic solution containing hyaluronic acid (HA) 0.4% and taurine (TAU) 0.5% with those of a PF ophthalmic solution containing HA 0.2% on ocular surface signs, symptoms, and morphological parameters in glaucoma patients under multiple long-term topical hypotensive therapy. Methods: Eligible patients underwent evaluation of ocular surface parameters by ocular surface disease index (OSDI) and glaucoma symptom scale (GSS) questionnaires, breakup time test (BUT), Schirmer I test, corneal and conjunctival staining (Oxford scale), and conjunctival in vivo confocal microscopy (Heidelberg Retina Tomograph 3, Heidelberg Engineering GmbH, Heidelberg, Germany). After the baseline visit, patients were randomized to use a PF ophthalmic solution containing HA 0.4% and TAU 0.5%, QID, in both eyes (group 1) or to use a PF ophthalmic solution containing HA 0.2%, QID (group 2) in addition to the ongoing preserved hypotensive treatment. Follow-up visits were scheduled at 30 and 90 days. Results: Thirty-nine eyes of 39 glaucoma patients were included in the study. At baseline, results of study tests of both groups were similar. After 90 days in group 1 the BUT (p = 0.01), the Oxford score (p = 0.03), the conjunctival goblet cells (CGC) density (p = 0.0005) ,and the two questionnaires score significantly improved (OSDI, p = 0.003; GSS, p = 0.003) compared to baseline values, while in group 2 all these parameters did not differ from baseline (BUT, p = 0.39; Oxford score, p = 0.54; CGC density, p = 0.33, OSDI p = 0.65, GSS, p = 0.25). The BUT and the CGC density were statistically different between groups both at 30 and 90 days (p = 0.04 and p = 0.04, respectively). The Schirmer I test did not statistically change after 90 days in both groups. Conclusions: The PF ophthalmic solution with HA 0.4% and TAU 0.5% seems to improve CGC density and reduce signs and symptoms of dry eye in glaucoma patients under long-term multiple preserved hypotensive therapy. Trial registration: ClinicalTrials.gov identifier, NCT03480295.

AB - Introduction: To compare the effects of a preservative-free (PF) ophthalmic solution containing hyaluronic acid (HA) 0.4% and taurine (TAU) 0.5% with those of a PF ophthalmic solution containing HA 0.2% on ocular surface signs, symptoms, and morphological parameters in glaucoma patients under multiple long-term topical hypotensive therapy. Methods: Eligible patients underwent evaluation of ocular surface parameters by ocular surface disease index (OSDI) and glaucoma symptom scale (GSS) questionnaires, breakup time test (BUT), Schirmer I test, corneal and conjunctival staining (Oxford scale), and conjunctival in vivo confocal microscopy (Heidelberg Retina Tomograph 3, Heidelberg Engineering GmbH, Heidelberg, Germany). After the baseline visit, patients were randomized to use a PF ophthalmic solution containing HA 0.4% and TAU 0.5%, QID, in both eyes (group 1) or to use a PF ophthalmic solution containing HA 0.2%, QID (group 2) in addition to the ongoing preserved hypotensive treatment. Follow-up visits were scheduled at 30 and 90 days. Results: Thirty-nine eyes of 39 glaucoma patients were included in the study. At baseline, results of study tests of both groups were similar. After 90 days in group 1 the BUT (p = 0.01), the Oxford score (p = 0.03), the conjunctival goblet cells (CGC) density (p = 0.0005) ,and the two questionnaires score significantly improved (OSDI, p = 0.003; GSS, p = 0.003) compared to baseline values, while in group 2 all these parameters did not differ from baseline (BUT, p = 0.39; Oxford score, p = 0.54; CGC density, p = 0.33, OSDI p = 0.65, GSS, p = 0.25). The BUT and the CGC density were statistically different between groups both at 30 and 90 days (p = 0.04 and p = 0.04, respectively). The Schirmer I test did not statistically change after 90 days in both groups. Conclusions: The PF ophthalmic solution with HA 0.4% and TAU 0.5% seems to improve CGC density and reduce signs and symptoms of dry eye in glaucoma patients under long-term multiple preserved hypotensive therapy. Trial registration: ClinicalTrials.gov identifier, NCT03480295.

KW - Conjunctival goblet cells

KW - Glaucoma

KW - Hyaluronic acid

KW - In vivo confocal microscopy

KW - Ophthalmology

KW - Taurine

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U2 - 10.1007/s12325-018-0699-8

DO - 10.1007/s12325-018-0699-8

M3 - Article

AN - SCOPUS:85045839894

VL - 35

SP - 686

EP - 696

JO - Advances in Therapy

JF - Advances in Therapy

SN - 0741-238X

IS - 5

ER -