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The effect of hydroxypropyl-guar nanoemulsion on signs and symptoms of dry eye

      Abstract

      Purpose

      To examine the effect of hydroxypropyl-guar nanoemulsion (HP-Guar nanoemulsion, Alcon Laboratories Ltd, Fort Worth, TX, USA) versus saline (0.9% sodium chloride; Pfizer Inc., Bentley WA Australia) on the comfort and tear film properties of people with dry eye disease both in the short-term (up to 2 h post-drop instillation) and longer-term (after 4 weeks of 4-times daily use), and to examine the effect on tear inflammatory markers after 4 weeks.

      Methods

      This was a prospective, investigator-masked, randomised, cross-over dispensing study. Twenty participants with dry eye disease (5 males: 15 females) with average age 46.9 ± 14.4 (range 26 to 70) years were randomized to either HP-Guar nanoemulsion, or saline eye drops. Ocular symptoms, lipid layer thickness, tear evaporation, tear osmolarity and non-invasive break-up time were measured pre-drop instillation, 1 h and 2 h post-eye drop instillation, and after 4-weeks of 4-times daily drop use. Tear inflammatory mediators were measured pre-drop instillation and after 4-weeks. After 4-weeks, patients had a 4-week washout period and then crossed over to the alternate drop.

      Results

      With HP-Guar nanoemulsion, participants reported less grittiness/burning/stinging 1 h post eye drop instillation compared to baseline (79.5 ± 23.3 vs. 66.8 ± 27.7, p = 0.02); less dryness 1 h and 2 h post eye drop instillation compared to baseline (77.8 ± 23.0 and 76.2 ± 23.7 vs. 61.0 ± 27.1 respectively, p < 0.01 for both); and greater overall satisfaction 1 h post drop instillation and after 4 weeks of daily use compared to baseline (80.4 ± 21.6 and 83.4 ± 16.6 vs. 68.6 ± 26.0 respectively, p ≤ 0.011 for both). With saline, participants reported less dryness after 4 weeks of daily use compared to baseline (74.2 ± 23.8 vs. 60.2 ± 24.0, p < 0.01). For HP-Guar nanoemulsion, average lipid layer thickness was significantly thicker 2 h post drop-instillation (79.5 ± 21.7 nm) compared to baseline (63.7 ± 18.9 nm) and the 4-week assessment (62.4 ± 23.1 nm, p < 0.01 for both). For saline, average lipid layer thickness was significantly thicker at 1 h and 2 h post eye drop instillation (76.0 ± 23.8 nm and 80.4 ± 24.8 nm) compared to baseline (61.0 ± 15.6 nm, p < 0.01 for both). There was no difference in inflammatory mediators or other tear variables between drops or visits.

      Conclusion

      HP-Guar nanoemulsion was more effective for improving a range of subjective dry eye symptoms both in the short and long-term compared to saline. Both HP-Guar nanoemulsion and saline transiently increased lipid layer thickness.

      Keywords

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      References

        • Papas E.B.
        The global prevalence of dry eye disease: A Bayesian view.
        Ophthalmic Physiol Opt. 2021; 41: 1254-1266https://doi.org/10.1111/opo.12888
        • Chan C.
        • Ziai S.
        • Myageri V.
        • Burns J.G.
        • Prokopich C.L.
        Economic burden and loss of quality of life from dry eye disease in Canada.
        BMJ Open Ophthalmol. 2021; 6: e000709
        • Jones L.
        • Downie L.E.
        • Korb D.
        • Benitez-del-Castillo J.M.
        • Dana R.
        • Deng S.X.
        • et al.
        TFOS DEWS II Management and Therapy Report.
        Ocul Surf. 2017; 15: 575-628
      1. Pucker AD, Ng SM, Nichols JJ. Over the counter (OTC) artificial tear drops for dry eye syndrome. Cochrane Database Syst Rev 2016;2(2):CD009729. https://doi.org/10.1002/14651858.CD009729.pub2.

        • López Bernal D.
        • Ubels J.L.
        Quantitative evaluation of the corneal epithelial barrier: effect of artificial tears and preservatives.
        Curr Eye Res. 1991; 10: 645-656https://doi.org/10.3109/02713689109013856
        • McDonald M.
        • Schachet J.L.
        • Lievens C.W.
        • Kern J.R.
        Systane® ultra lubricant eye drops for treatment of contact lens-related dryness.
        Eye Contact Lens. 2014; 40: 106-110https://doi.org/10.1097/icl.0000000000000018
        • Garofalo R.
        • Kunnen C.
        • Rangarajan R.
        • Manoj V.
        • Ketelson H.
        Relieving the symptoms of dry eye disease: update on lubricating eye drops containing hydroxypropyl-guar.
        Clin Exp Optom. 2021; 104: 826-834
        • Pucker A.D.
        • McGwin Jr., G.
        • Franklin Q.X.
        • Dubey J.
        • Nattis A.
        • Lievens C.
        Application of systane complete for the treatment of contact lens discomfort.
        Cont Lens Anterior Eye. 2021; 44101399https://doi.org/10.1016/j.clae.2020.12.004
        • Silverstein S.
        • Yeu E.
        • Tauber J.
        • Guillon M.
        • Jones L.
        • Galarreta D.
        • et al.
        Symptom Relief Following a Single Dose of Propylene Glycol-Hydroxypropyl Guar Nanoemulsion in Patients with Dry Eye Disease: A Phase IV.
        Multicenter Trial Clin Ophthalmol. 2020; 14: 3167-3177https://doi.org/10.2147/OPTH.S263362
        • Yeu E.
        • Silverstein S.
        • Guillon M.
        • Schulze M.M.
        • Galarreta D.
        • Srinivasan S.
        • et al.
        Efficacy and Safety of Phospholipid Nanoemulsion-Based Ocular Lubricant for the Management of Various Subtypes of Dry Eye Disease: A Phase IV.
        Multicenter Trial Clin Ophthalmol. 2020; 14: 2561-2570https://doi.org/10.2147/OPTH.S261318
        • Fuller D.G.
        • Potts K.
        • Kim J.
        Noninvasive tear breakup times and ocular surface disease.
        Optometry and vision science : official publication of the American Academy of Optometry. 2013; 90: 1086-1091https://doi.org/10.1097/OPX.0000000000000023
        • Finis D.
        • Pischel N.
        • Schrader S.
        • Geerling G.
        Evaluation of lipid layer thickness measurement of the tear film as a diagnostic tool for Meibomian gland dysfunction.
        Cornea. 2013; 32: 1549-1553https://doi.org/10.1097/ICO.0b013e3182a7f3e1
        • Terry R.L.
        • Schnider C.M.
        • Holden B.A.
        • Cornish RUTH
        • Grant TIM
        • Sweeney DEBORAH
        • et al.
        CCLRU standards for success of daily and extended wear contact lenses.
        Optom Vis Sci. 1993; 70: 234-243
        • Schiffman R.M.
        • Christianson M.D.
        • Jacobsen G.
        • Hirsch J.D.
        • Reis B.L.
        Reliability and validity of the Ocular Surface Disease Index.
        Arch Ophthalmol. 2000; 118: 615-621https://doi.org/10.1001/archopht.118.5.615
        • Markoulli M.
        • Duong T.B.
        • Lin M.
        • Papas E.
        Imaging the Tear Film: A Comparison Between the Subjective Keeler Tearscope-Plus and the Objective Oculus(R) Keratograph 5M and LipiView(R) Interferometer.
        Curr Eye Res. 2018; 43: 155-162https://doi.org/10.1080/02713683.2017.1393092
        • Pepose J.S.
        • Sullivan B.D.
        • Foulks G.N.
        • Lemp M.A.
        The value of tear osmolarity as a metric in evaluating the response to dry eye therapy in the clinic and in clinical trials.
        Am J Ophthalmol. 2014; 157: 4-6 e1https://doi.org/10.1016/j.ajo.2013.10.020
        • Rohit A.
        • Ehrmann K.
        • Naduvilath T.
        • Willcox M.
        • Stapleton F.
        Validating a new device for measuring tear evaporation rates.
        Ophthalmic Physiol Opt. 2014; 34: 53-62https://doi.org/10.1111/opo.12096
        • Markoulli M.
        • Papas E.
        • Petznick A.
        • Holden B.
        Validation of the flush method as an alternative to basal or reflex tear collection.
        Curr Eye Res. 2011; 36: 198-207https://doi.org/10.3109/02713683.2010.542867
        • Markoulli M.
        • Papas E.
        • Cole N.
        • Holden B.
        Effect of contact lens wear on the diurnal profile of matrix metalloproteinase 9 in tears.
        Optom Vis Sci. 2013; 90: 419-429https://doi.org/10.1097/OPX.0b013e31828d7d3b
        • Luo L.
        • Li D.Q.
        • Doshi A.
        • Farley W.
        • Corrales R.M.
        • Pflugfelder S.C.
        Experimental dry eye stimulates production of inflammatory cytokines and MMP-9 and activates MAPK signaling pathways on the ocular surface.
        Invest Ophthalmol Vis Sci. 2004; 45: 4293-4301https://doi.org/10.1167/iovs.03-1145
        • Chotikavanich S.
        • de Paiva C.S.
        • Li de Q.
        • Chen J.J.
        • Bian F.
        • Farley W.J.
        • et al.
        Production and activity of matrix metalloproteinase-9 on the ocular surface increase in dysfunctional tear syndrome.
        Invest Ophthalmol Vis Sci. 2009; 50: 3203-3209https://doi.org/10.1167/iovs.08-2476
        • Alghamdi W.
        • Markoulli M.
        • Papas E.
        The relationship between tear film MMP-9 and meibomian gland changes during soft contact lens wear.
        Cont Lens Anterior Eye. 2020; 43: 154-158https://doi.org/10.1016/j.clae.2019.07.007
        • Rolando M.
        • Autori S.
        • Badino F.
        • Barabino S.
        Protecting the ocular surface and improving the quality of life of dry eye patients: a study of the efficacy of an HP-guar containing ocular lubricant in a population of dry eye patients.
        J Ocul Pharmacol Ther. 2009; 25: 271-278https://doi.org/10.1089/jop.2008.0026
        • Markoulli M.
        • Sobbizadeh A.
        • Tan J.
        • Briggs N.
        • Coroneo M.
        The Effect of Optive and Optive Advanced Artificial Tears on the Healthy Tear Film.
        Curr Eye Res. 2018; 43: 588-594https://doi.org/10.1080/02713683.2018.1433860
        • Craig J.P.
        • Tomlinson A.
        Importance of the lipid layer in human tear film stability and evaporation.
        Optom Vis Sci. 1997; 74: 8-13
        • Craig J.P.
        • Muntz A.
        • Wang M.T.M.
        • Luensmann D.
        • Tan J.
        • Trave Huarte S.
        • et al.
        Developing evidence-based guidance for the treatment of dry eye disease with artificial tear supplements: A six-month multicentre, double-masked randomised controlled trial.
        Ocul Surf. 2021; 20: 62-69
        • Begley C.G.
        • Chalmers R.L.
        • Abetz L.
        • Venkataraman K.
        • Mertzanis P.
        • Caffery B.A.
        • et al.
        The relationship between habitual patient-reported symptoms and clinical signs among patients with dry eye of varying severity.
        Invest Ophthalmol Vis Sci. 2003; 44: 4753
        • Nichols K.K.
        • Nichols J.J.
        • Mph M.S.
        • Mitchell G.L.
        The lack of association between signs and symptoms in patients with dry eye disease.
        Cornea. 2004; 23: 762-770
        • Markoulli M.
        • Papas E.B.
        • Cole N.A.
        • Holden B.A.
        The diurnal variation of matrix metalloproteinase-9 and its associated factors in human tears.
        Invest Ophthalmol Vis Sci. 2012; 53: 1479-1484https://doi.org/10.1167/iovs.11-8365
      2. Lanzini M, Curcio C, Colabelli-Gisoldi RA, Mastropasqua A, Calienno R, Agnifili L, et al. In Vivo and Impression Cytology Study on the Effect of Compatible Solutes Eye Drops on the Ocular Surface Epithelial Cell Quality in Dry Eye Patients. Mediators Inflamm 2015;2015:351424. https://doi.org/10.1155/2015/351424.

        • Deinema L.A.
        • Vingrys A.J.
        • Wong C.Y.
        • Jackson D.C.
        • Chinnery H.R.
        • Downie L.E.
        A Randomized, Double-Masked, Placebo-Controlled Clinical Trial of Two Forms of Omega-3 Supplements for Treating Dry Eye Disease.
        Ophthalmology. 2017; 124: 43-52https://doi.org/10.1016/j.ophtha.2016.09.023