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

Adv Ther. 2018 May;35(5):686-696. doi: 10.1007/s12325-018-0699-8. Epub 2018 Apr 23.

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.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Antihypertensive Agents / therapeutic use*
  • Dry Eye Syndromes* / diagnosis
  • Dry Eye Syndromes* / drug therapy
  • Dry Eye Syndromes* / etiology
  • Female
  • Glaucoma* / diagnosis
  • Glaucoma* / drug therapy
  • Humans
  • Hyaluronic Acid* / administration & dosage
  • Hyaluronic Acid* / adverse effects
  • Male
  • Microscopy, Confocal / methods
  • Middle Aged
  • Ophthalmic Solutions / administration & dosage
  • Ophthalmic Solutions / adverse effects
  • Preservatives, Pharmaceutical / administration & dosage
  • Preservatives, Pharmaceutical / adverse effects
  • Prospective Studies
  • Single-Blind Method
  • Taurine* / administration & dosage
  • Taurine* / adverse effects
  • Treatment Outcome

Substances

  • Antihypertensive Agents
  • Ophthalmic Solutions
  • Preservatives, Pharmaceutical
  • Taurine
  • Hyaluronic Acid

Associated data

  • ClinicalTrials.gov/NCT03480295