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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
Authors:Gloria Roberti  Luca Agnifili  Francesca Berardo  Ivano Riva  Michele Figus  Gianluca Manni  Luciano Quaranta  Francesco Oddone
Institution:1.Glaucoma Unit,IRCCS Fondazione G.B. Bietti,Rome,Italy;2.Ophthalmology Clinic, Department of Medicine and Aging Science,University G. D’Annunzio of Chieti-Pescara,Chieti,Italy;3.Department of Surgical, Medical, and Molecular Pathology and Critical Care,University of Pisa,Pisa,Italy;4.DSCMT, University of Rome Tor Vergata,Rome,Italy;5.Section of Ophthalmology,Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health University of Brescia,Brescia,Italy
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:
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