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Erschienen in: Graefe's Archive for Clinical and Experimental Ophthalmology 6/2005

01.06.2005 | Clinical Investigation

Efficacy and safety of 0.18% sodium hyaluronate in patients with moderate dry eye syndrome and superficial keratitis

verfasst von: Françoise Brignole, Pierre-Jean Pisella, Bénédicte Dupas, Vincent Baeyens, Christophe Baudouin

Erschienen in: Graefe's Archive for Clinical and Experimental Ophthalmology | Ausgabe 6/2005

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Abstract

Background

Sodium hyaluronate (SH) is used in patients with dry eye. We evaluated the efficacy and safety of SH and carboxymethylcellulose (CMC) in the treatment of dry eye syndrome with superficial keratitis.

Methods

A total of 22 patients with moderate dry eye and superficial keratitis were enrolled in a prospective, randomised, masked-observer, parallel-group, single-centre study. Patients were randomly assigned to a 0.18% SH or 1% CMC solution for a 2-month period. In addition to the commonly assessed parameters in patients with dry eye (among others symptoms and corneal staining with fluorescein), flow cytometry analysis of CD44, HLA DR expressions in impression cytology was investigated as a potential efficacy parameter.

Results

Both treatments improved the symptoms and ocular surface and were well tolerated. SH significantly (p<0.05) decreased CD44 values compared with CMC. Comfort was significantly (P<0.05) better in the SH group than that in the CMC group throughout the study. Recovery in keratitis (type, extent and depth) and symptoms were faster in the SH group than in the CMC group. Blurred vision was reported by patients in the CMC group only.

Conclusions

SH was well tolerated and tended to show a faster efficacy than did the CMC-based formulation in patients with moderate dry eye and superficial keratitis. SH could therefore advantageously be prescribed from the early stages of dry eye disease. This study also showed that flow cytometry in impression cytology specimens is a reliable tool for exploring the ocular surface at the epithelial level and that CD44, in addition to HLA DR, could be an interesting endpoint for future trials in dry eye syndrome with products based on SH.
Literatur
1.
Zurück zum Zitat Aziz KE, Wakefield D (1995) In vivo and in vitro expression of adhesion molecules by peripheral blood lymphocytes from patients with primary Sjogren’s syndrome: culture-associated enhancement of LECAM-1 and CD44. Rheumatol Int 15:69–74CrossRefPubMed Aziz KE, Wakefield D (1995) In vivo and in vitro expression of adhesion molecules by peripheral blood lymphocytes from patients with primary Sjogren’s syndrome: culture-associated enhancement of LECAM-1 and CD44. Rheumatol Int 15:69–74CrossRefPubMed
3.
Zurück zum Zitat Baudouin C, Haouat N, Brignole F, Bayle J, Gastaud P (1992) Immunopathological findings in conjunctival cells using immunofluorescence staining of impression cytology specimens. Br J Ophthalmol 76:545–549 Baudouin C, Haouat N, Brignole F, Bayle J, Gastaud P (1992) Immunopathological findings in conjunctival cells using immunofluorescence staining of impression cytology specimens. Br J Ophthalmol 76:545–549
4.
Zurück zum Zitat Baudouin C, Brignole F, Becquet F, Pisella PJ, Goguel A (1997) Flow cytometry in impression cytology specimens. Invest Ophthalmol Vis Sci 38:1458–1464PubMed Baudouin C, Brignole F, Becquet F, Pisella PJ, Goguel A (1997) Flow cytometry in impression cytology specimens. Invest Ophthalmol Vis Sci 38:1458–1464PubMed
5.
Zurück zum Zitat Bernatchez SF, Camber O, Tabatabay C, Gurny R (1993) Use of hyaluronic acid in ocular therapy. In: Edman P (ed) Biopharmaceutics of ocular drug delivery, CRC, Boca Raton, pp 105–120 Bernatchez SF, Camber O, Tabatabay C, Gurny R (1993) Use of hyaluronic acid in ocular therapy. In: Edman P (ed) Biopharmaceutics of ocular drug delivery, CRC, Boca Raton, pp 105–120
6.
Zurück zum Zitat Bernatchez SF, Tabatabay C, Gurny R (1993) Sodium hyaluronate 0.25% used as a vehicle increases the bioavailability of topically administered gentamicin. Graefes Arch Clin Exp Ophthalmol 231:157–171 Bernatchez SF, Tabatabay C, Gurny R (1993) Sodium hyaluronate 0.25% used as a vehicle increases the bioavailability of topically administered gentamicin. Graefes Arch Clin Exp Ophthalmol 231:157–171
7.
Zurück zum Zitat Brignole F, De Saint-Jean M, Goldschild M, Becquet F, Goguel A, Baudouin C (1998) Expression of Fas–Fas ligand antigens and apoptotic marker AP02.7 by the human conjunctival epithelium, positive correlation with Class II HLA DR expression in inflammatory ocular surface disorders. Exp Eye Res 67:687–697CrossRefPubMed Brignole F, De Saint-Jean M, Goldschild M, Becquet F, Goguel A, Baudouin C (1998) Expression of Fas–Fas ligand antigens and apoptotic marker AP02.7 by the human conjunctival epithelium, positive correlation with Class II HLA DR expression in inflammatory ocular surface disorders. Exp Eye Res 67:687–697CrossRefPubMed
8.
Zurück zum Zitat Cerulli L, Trematerra M, Zapelloni A, D’Ambrosi E, Corsi A (1993) Clinical evaluation of L02A eye drop versus control eye drop in patients suffering from lacrymal hyposecretion. Ann Ottalmol Clin Ocul 119:49–55 Cerulli L, Trematerra M, Zapelloni A, D’Ambrosi E, Corsi A (1993) Clinical evaluation of L02A eye drop versus control eye drop in patients suffering from lacrymal hyposecretion. Ann Ottalmol Clin Ocul 119:49–55
9.
Zurück zum Zitat Condon PI, McEwen CG, Wright M, Mackintosh G, Prescott RJ, McDonald C (1999) Double-blind, randomised, placebo-controlled, crossover, multicentre study to determine the efficacy of a 0.1% (w/v) sodium hyaluronate solution (Fermavisc) in the treatment of dry eye syndrome. Br J Ophthalmol 83:1121–1124 Condon PI, McEwen CG, Wright M, Mackintosh G, Prescott RJ, McDonald C (1999) Double-blind, randomised, placebo-controlled, crossover, multicentre study to determine the efficacy of a 0.1% (w/v) sodium hyaluronate solution (Fermavisc) in the treatment of dry eye syndrome. Br J Ophthalmol 83:1121–1124
10.
Zurück zum Zitat Fukuda M (1991) Lysosomal membrane glycoproteins. Structure, biosynthesis, and intracellular trafficking. J Biol Chem 266:21327–21330PubMed Fukuda M (1991) Lysosomal membrane glycoproteins. Structure, biosynthesis, and intracellular trafficking. J Biol Chem 266:21327–21330PubMed
11.
Zurück zum Zitat Gomes JAP, Amankwah R, Powell-Richards A, Dua HS (2004) Sodium hyaluronate (hyaluronic acid) promotes migration of human corneal epithelial cells in vitro. Br J Ophthalmol 88:821–825 Gomes JAP, Amankwah R, Powell-Richards A, Dua HS (2004) Sodium hyaluronate (hyaluronic acid) promotes migration of human corneal epithelial cells in vitro. Br J Ophthalmol 88:821–825
12.
Zurück zum Zitat Gurny R, Ryser JE, Tabatabay C, Martenet M, Edman P, Camber O (1990) Precorneal residence time in humans of sodium hyaluronate as measured by gamma scintigraphy. Graefes Arch Clin Exp Ophthalmol 228:510–512 Gurny R, Ryser JE, Tabatabay C, Martenet M, Edman P, Camber O (1990) Precorneal residence time in humans of sodium hyaluronate as measured by gamma scintigraphy. Graefes Arch Clin Exp Ophthalmol 228:510–512
13.
Zurück zum Zitat Hamano T, Horimoto K, Lee M, Komemushi S (1996) Sodium hyaluronate eye drops enhance tear film stability. Jpn J Ophthalmol 40:62–65PubMed Hamano T, Horimoto K, Lee M, Komemushi S (1996) Sodium hyaluronate eye drops enhance tear film stability. Jpn J Ophthalmol 40:62–65PubMed
14.
Zurück zum Zitat Iester A, Brezzo MV, Rolando M (1993) Double-masked clinical trial of an unpreserved hyaluronic acid based eye drop in dry eye syndromes. Ann Ottalmol Clin Ocul 119:17–31 Iester A, Brezzo MV, Rolando M (1993) Double-masked clinical trial of an unpreserved hyaluronic acid based eye drop in dry eye syndromes. Ann Ottalmol Clin Ocul 119:17–31
15.
Zurück zum Zitat Lemp MA (1995) Report of the National Eye Institute/Industry Workshop on clinical trials in dry eyes. CLAO J 21:221–232PubMed Lemp MA (1995) Report of the National Eye Institute/Industry Workshop on clinical trials in dry eyes. CLAO J 21:221–232PubMed
16.
Zurück zum Zitat Levesque MC, Mackin DA, Fleming JA, St Clair EW (2000) Serum levels of soluble CD44 in primary Sjogren’s syndrome. J Rheumatol 27:1444–1449PubMed Levesque MC, Mackin DA, Fleming JA, St Clair EW (2000) Serum levels of soluble CD44 in primary Sjogren’s syndrome. J Rheumatol 27:1444–1449PubMed
17.
Zurück zum Zitat Limberg MB, Mc Caa C, Kissling GE, Kaufman HE (1987) Topical application of hyaluronic acid and chondroitin sulfate in the treatment of dry eyes. Am J Ophthalmol 103:194–197 Limberg MB, Mc Caa C, Kissling GE, Kaufman HE (1987) Topical application of hyaluronic acid and chondroitin sulfate in the treatment of dry eyes. Am J Ophthalmol 103:194–197
18.
Zurück zum Zitat McMonnies CW (1986) Key questions in a dry eye history. J Am Optom Assoc 57:512–517PubMed McMonnies CW (1986) Key questions in a dry eye history. J Am Optom Assoc 57:512–517PubMed
19.
Zurück zum Zitat McMonnies CW, Ho A (1987) Patient history in screening for dry eye conditions. J Am Optom Assoc 58:296–301PubMed McMonnies CW, Ho A (1987) Patient history in screening for dry eye conditions. J Am Optom Assoc 58:296–301PubMed
20.
Zurück zum Zitat McMonnies CW, Ho A (1987) Responses to a dry eye questionnaire from a normal population. J Am Optom Assoc 58:588–591PubMed McMonnies CW, Ho A (1987) Responses to a dry eye questionnaire from a normal population. J Am Optom Assoc 58:588–591PubMed
21.
Zurück zum Zitat Mengher L, Pandher K, Bron AJ, Davey CC (1986) Effect of sodium hyaluronate (0.1%) on break-up time (NIBUT) in patients with dry eyes. Br J Ophthalmol 70:442–447 Mengher L, Pandher K, Bron AJ, Davey CC (1986) Effect of sodium hyaluronate (0.1%) on break-up time (NIBUT) in patients with dry eyes. Br J Ophthalmol 70:442–447
22.
Zurück zum Zitat Meyer K (1958) Chemical structure of hyaluronic acid. Fed Proc 17:1075–1077PubMed Meyer K (1958) Chemical structure of hyaluronic acid. Fed Proc 17:1075–1077PubMed
23.
Zurück zum Zitat Miyazaki T, Miyauchi S, Nakamura T, Takeshita S, Horie K (1996) The effect of sodium hyaluronate on the growth of rabbit corneal epithelial cells in vitro. J Ocul Pharmacol Ther 12:409–415PubMed Miyazaki T, Miyauchi S, Nakamura T, Takeshita S, Horie K (1996) The effect of sodium hyaluronate on the growth of rabbit corneal epithelial cells in vitro. J Ocul Pharmacol Ther 12:409–415PubMed
24.
Zurück zum Zitat Nagy H, Goda K, Fenyvesi F, Bacso Z, Szilasi M, Kappelmayer J, Lustyik G, Cianfriglia M, Szabo G Jr (2004) Distinct groups of multidrug resistance modulating agents are distinguished by competition of P-glycoprotein-specific antibodies. Biochem Biophys Res Commun 315:942–949CrossRefPubMed Nagy H, Goda K, Fenyvesi F, Bacso Z, Szilasi M, Kappelmayer J, Lustyik G, Cianfriglia M, Szabo G Jr (2004) Distinct groups of multidrug resistance modulating agents are distinguished by competition of P-glycoprotein-specific antibodies. Biochem Biophys Res Commun 315:942–949CrossRefPubMed
25.
Zurück zum Zitat Nakamura M, Hikida M, Nakano T (1992) Concentration and molecular weight dependency of rabbit corneal epithelial wound healing on hyaluronan. Curr Eye Res 11:981–986PubMed Nakamura M, Hikida M, Nakano T (1992) Concentration and molecular weight dependency of rabbit corneal epithelial wound healing on hyaluronan. Curr Eye Res 11:981–986PubMed
26.
Zurück zum Zitat Nakamura M, Nakano T, Mibu H, Hikida M (1995) Hyaluronan stimulates epithelial wound healing in the rabbit cornea. Folia Ophthalmol Jpn 46:1256–1260 Nakamura M, Nakano T, Mibu H, Hikida M (1995) Hyaluronan stimulates epithelial wound healing in the rabbit cornea. Folia Ophthalmol Jpn 46:1256–1260
27.
Zurück zum Zitat Orsoni JG, Chiari M, Guazi A, De Carli M, Guidolin D (1988) Efficacy of hyaluronic acid solution in the treatment of sicca syndrome. Ophtalmologie 2:355–357PubMed Orsoni JG, Chiari M, Guazi A, De Carli M, Guidolin D (1988) Efficacy of hyaluronic acid solution in the treatment of sicca syndrome. Ophtalmologie 2:355–357PubMed
28.
Zurück zum Zitat Pisella PJ, Debbasch C, Hamard P, Creuzot-Garcher C, Rat P, Brignole F, Baudouin C (2004) Conjunctival proinflammatory and proapoptotic effects of latanoprost and preserved and unpreserved timolol: an ex vivo and in vitro study. Invest Ophthalmol Vis Sci 45:1360–1368 Pisella PJ, Debbasch C, Hamard P, Creuzot-Garcher C, Rat P, Brignole F, Baudouin C (2004) Conjunctival proinflammatory and proapoptotic effects of latanoprost and preserved and unpreserved timolol: an ex vivo and in vitro study. Invest Ophthalmol Vis Sci 45:1360–1368
29.
Zurück zum Zitat Sand BB, Marner K, Norn MS (1989) Sodium hyaluronate in the treatment of keratoconjunctivitis sicca. A double masked clinical trial. Acta Ophthalmol 67:181–183 Sand BB, Marner K, Norn MS (1989) Sodium hyaluronate in the treatment of keratoconjunctivitis sicca. A double masked clinical trial. Acta Ophthalmol 67:181–183
30.
Zurück zum Zitat Scrivanti M, Taiti L, Mencucci R., Bardi L, Salvi G (1996) Syndrome sec oculaire: utilisation d’un nouveau substitut lacrymal (LO2A). Ophtalmologie 10:24–27 Scrivanti M, Taiti L, Mencucci R., Bardi L, Salvi G (1996) Syndrome sec oculaire: utilisation d’un nouveau substitut lacrymal (LO2A). Ophtalmologie 10:24–27
31.
Zurück zum Zitat Shimmura S, Ono M, Shinozaki K, Toda I, Takamura E, Mashima Y, Tsubota K (1995) Sodium hyaluronate eye drops in the treatment of dry eyes. Br J Ophthalmol 79:1007–1011 Shimmura S, Ono M, Shinozaki K, Toda I, Takamura E, Mashima Y, Tsubota K (1995) Sodium hyaluronate eye drops in the treatment of dry eyes. Br J Ophthalmol 79:1007–1011
32.
Zurück zum Zitat Skubitz KM, Campbell KD, Skubitz AP (2000) CD63 associates with CD11/CD18 in large detergent-resistant complexes after translocation to the cell surface in human neutrophils. FEBS Lett 469:52–56CrossRefPubMed Skubitz KM, Campbell KD, Skubitz AP (2000) CD63 associates with CD11/CD18 in large detergent-resistant complexes after translocation to the cell surface in human neutrophils. FEBS Lett 469:52–56CrossRefPubMed
33.
Zurück zum Zitat Taiti L, Scrivanti M, Mencucci R, Bardi L, Salvi G (1996) A double-masked crossover comparison of a new artificial tear preparation containing hyaluronic acid (L02A) and a reference artificial tear preparation containing hydroxypropyl-methylcellulose in dry-eye syndrome treatment. Ann Ottalmol Clin Ocul 119:33–46 Taiti L, Scrivanti M, Mencucci R, Bardi L, Salvi G (1996) A double-masked crossover comparison of a new artificial tear preparation containing hyaluronic acid (L02A) and a reference artificial tear preparation containing hydroxypropyl-methylcellulose in dry-eye syndrome treatment. Ann Ottalmol Clin Ocul 119:33–46
34.
Zurück zum Zitat Tiffany JM (1994) Viscoelastic properties of human tears and polymer solutions. Adv Exp Med Biol 350:267–270PubMed Tiffany JM (1994) Viscoelastic properties of human tears and polymer solutions. Adv Exp Med Biol 350:267–270PubMed
35.
Zurück zum Zitat Zhu SN, Nolle B, Duncker G (1997) Expression of adhesion molecule CD44 on human corneas. Br J Ophthalmol 81:80–84 Zhu SN, Nolle B, Duncker G (1997) Expression of adhesion molecule CD44 on human corneas. Br J Ophthalmol 81:80–84
Metadaten
Titel
Efficacy and safety of 0.18% sodium hyaluronate in patients with moderate dry eye syndrome and superficial keratitis
verfasst von
Françoise Brignole
Pierre-Jean Pisella
Bénédicte Dupas
Vincent Baeyens
Christophe Baudouin
Publikationsdatum
01.06.2005
Erschienen in
Graefe's Archive for Clinical and Experimental Ophthalmology / Ausgabe 6/2005
Print ISSN: 0721-832X
Elektronische ISSN: 1435-702X
DOI
https://doi.org/10.1007/s00417-004-1040-6

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