Efficacy and safety of a fluid carbomer gel versus a conventional carbomer gel in dry eye treatment;Efficacité et tolérance d'un gel de carbomère fluide versus un gel de carbomère classique lors du traitement du syndrome sec

Journal Francais d'Ophtalmologie

Volumn 27, Issue 2, 2004, Pages 130-135

  Chiambaretta, F ^a   Pouliquen, P ^b   Menerath, J M ^c   Pilotaz, F ^b   Rebika, H ^b   Rigal, D ^a  

^a SERVICE DE RHUMATOLOGIE   (France)

^b Laboratoires Thea   (France)

^c Cabinet Ophtalmologique   (France)

Author keywords

Carbomer 974P; Clinical trial; Dry eye; Ophthalmic fluid gel; Preservative; PVA; Vial

Indexed keywords

AQUALARM; CARBOMER; CARBOPOL 974P; CIVIGEL; GEL LARMES; LACRIFLUID; LACRIGEL; LACRYVISC; POLYACRYLIC ACID; POLYVINYL ALCOHOL; PRESERVATIVE; SICCAFLUID;

ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORNEA; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRY EYE; EYE PAIN; EYELID EDEMA; FEMALE; GEL; HEADACHE; HUMAN; LACRIMAL GLAND; LIQUID; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL; SCHIRMER TEST; SCORING SYSTEM; SINGLE BLIND PROCEDURE; SYMPTOMATOLOGY; TREATMENT OUTCOME;

EID: 1642405005     PISSN: 01815512     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0181-5512(04)96106-2     Document Type: Article

References (29)

1. Liotet S, Van Bijsterveld OP, Blétry O, Chomette G, Moulias R, Arrata M. L'œil sec. Rap Soc Fr Ophtalmol. Paris: Masson; 1987.
2. Marquardt R. Therapy of dry eye. In: Lemp MA, Marquardt R, editors. The dry eye. Berlin: Spinger-Verlag; 199: p 183-219.
3. Pouliquen P. Les gels de carbomère dans le traitement de l'œil sec. J Fr Ophtalmol, 1999;22:903-13.
4. Laroche L, Arrata M, Brasseur G, Lagoutte F, Le Mer Y, Lumbroso P et al. Traitement de la sécheresse oculaire par gel lacrymal: étude multicentrique randomisée. J Fr Ophtalmol, 1991;14:321-6.
5. Roncin S, Mage F, Youinou P, Pennec YL, Jouquan J, Colin J. Le traitement médical actuel de l'œil sec. J Fr Ophtalmol, 1995;18:708-30.
6. Sirbat D, Marchal-Heussler L, Hoffman M, Maincent P. Moyens d'amélioration de la biodisponibilité pour la voie topique. J Fr Ophtalmol, 2000;23:505-9.
7. Woodley J. Bioadhesion: new possibilities for drug administration? Clin Pharmacokinet, 2001;40:77-84.
8. Edsman K, Carlfors J, Hardju K. Rheological evaluation and ocular contact time of some carbomer gels for ophthalmic use. Int J Pharm, 1996;137:233-41.
9. Brewitt H. Rapport clinique intitulé: Residence time of OLL-GEL in the conjunctival sac and on the ocular surface, 1994, non publié.
10. e ed. Paris: OVP, Editions du Vidal®; 2001.
11. Koleng JJ, McGinity JW, Carbomer X. In: Handbook of pharmaceutical excipients 3rd ed. Kibbe AH editor. Washington: American Pharmaceutical Association & Pharmaceutical Press; 2000: p. 79-82.
12. Rodriguez F, Michaud P, Lovera V. Les produits gélifiants: caractérisation et évaluation pour un dossier pharmaceutique. STA Pharma Prat, 1999;9(hors série):15-8.
13. Latour E, Doucine C. Minor role of viscosity in precorneal residence time of carbomer formulations in rabbits. Invest Ophthalmol Vis Sci, 1999;40:S547.
14. Ravissot GPJ. Carbopol, polymères anciens, produits nouveaux. In: Les excipients à l'horizon 2000. Colloque SIC-APGI 3 mars 1999. STP Pharma Prat, 1999;9(hors série):3-9.
15. Bron AJ, Daubas P, Siou-Mermet R, Trinquand C. Comparison of the efficacy and safety of two eye gels in the treatment of dry eyes: Lacrinorm® and Viscotears®. Eye, 1998;12:839-47.
16. Gambaro S, Bellusi M, Formenti F, Lore V, Spinelli D. The use of a carbopol-mannitol gel combination in the treatment of dry eye. In: Van Bijsterveld OP, Lemp MA, Spinelli D, editors. The lacrimal system. Symposium on the lacrimal system, 1990 March 17; Singapore. Amsterdam: Kugler & Ghedini; 1991: p. 103-7.
17. Marner K, Mooller PM, Dillon M, Rask-Pedersen E. Viscous carbomer eye drops in patients with dry eyes. Efficacy and safety. A randomized, open, cross-over, multicentre study. Acta Ophthalmol Scand, 1996;74:249-52.
18. Bron AJ, Mangat H, Quinlan M, Foley-Nolan A, Eustace P, Fsadni M et al. Polyacrylic acid gel in patients with dry eyes: a randomised comparison with polyvinyl alcohol. Eur J Ophthalmol, 1998;8:81-9.
19. Brodwall J, Alme G, Gedde-Dahl S, Smith J, Lilliedahl NP, Kunz PA et al. A comparative study of polyacrylic acid (Viscotears®) liquid gel versus polyvinylalcohol in the treatment of dry eyes. Acta Ophthalmol Scand, 1997;75:457-61.
20. Sullivan U, McCurrach F, Lee S, Taylor HR, Rolando M, Marechal-Courtois C et al. Efficacy and safety of 0.3% carbomer gel compared to placebo in patients with moderate-to-severe dry eye syndrome. Ophthalmology, 1997;104:1402-8.
21. Baldwin H. Rapport Clinique TPO 10/00 Siccafluid UD, 2001, non publié.
22. Al-Mansouri S, Tabbara KF, Rask-Pedersen E. Lubrithal® (Leo viscous eye gel), precorneal residence time in normal and dry eyes. Doc Ophthalmol, 1994;88:187-94.
23. Marquardt R, Christ T. Untersuchungen zur Verweildauer von Tränenersatzmitteln. Klin Monatsbl Augenheilkd, 1986;189:254-7.
24. Wilson CG, Zhu YP, Frier M, Rao LS, Gilchrist P, Perkins AC. Ocular contact time of a carbomer gel (GelTears®) in humans. Br J Ophthalmol, 1998;82:1131-4.
25. J Thébault. Rapport Clinique R.94.DH 135.03. Protocole P.05.94.G.DC 156.03 intitulé: Double-blind clinical trial between OII-gel and Oculotect Fluid® eyedrops in 16 subjects [indication: dry eye] to compare local tolerance and safety, non publié.
26. Realdon N, Ragazzi E, Dal Zotto M, Dalla Fini G. Possibilities of conveying a cationic drug in carbomer hydrogels. Drug Dev Ind Pharm, 1998;24:337-43.
27. Tissié G, Rao LS, Sarrazin P, Coquelet C. Benzalkonium chloride interactions with polymers used as viscosity increasing agents in artificial tears. Joint European Research Meeting in Ophthalmology and Vision 1997 October 15-19; Montpellier, France. Poster 20.
28. Rizzo A. Protocole n° 990701 intitulé: Permeabilidad del cloruro de benzalconio como conservante de colirios a través de diferentes membranas. 1999, non publié.
29. Debbasch C, Pisella PJ, Rat P, Warnet JM, Baudouin C. Evaluation de la cytotoxicité de trois substituts lacrymaux utilisés dans le traitement des syndromes sec. J Fr Ophtalmol, 2000;23:505-9.