Prophylactic effectiveness of tobramycin-dexamethasone eye drops compared with tobramycin/vehicle eye drops in controlling post-surgical inflammation in cataract patients: Prospective, randomised, double-masked, two-arm, parallel-group, placebo-controlled, multicentre study

Clinical Drug Investigation

Volumn 24, Issue 9, 2004, Pages 523-533

  Notivol, Ricardo ^a,c   Amin, Dina ^b   Whitling, Anna ^b   Wells, David ^b   Kennedy, Margaret ^b   Cockrum, Paul C ^b  

^a Departments of Haematology   (Spain)

^b ALCON RESEARCH LTD   (United States)

^c Biokit   (Spain)

Author keywords

[No Author keywords available]

Indexed keywords

DEXAMETHASONE PLUS TOBRAMYCIN; DRUG VEHICLE; EYE DROPS; PLACEBO; TOBRAMYCIN;

ADULT; AGED; ALLERGIC REACTION; ARTICLE; CATARACT; CLINICAL TRIAL; CONJUNCTIVAL HYPEREMIA; CONJUNCTIVITIS; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORNEA EDEMA; DOUBLE BLIND PROCEDURE; DRUG EFFECT; DRUG EFFICACY; DRUG SAFETY; EXTRACAPSULAR CATARACT EXTRACTION; FEMALE; FIBRIN DEPOSITION; FOLLOW UP; HUMAN; LENS IMPLANTATION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OCULAR ALLERGIC REACTION; PARALLEL DESIGN; POSTOPERATIVE INFLAMMATION; PRIORITY JOURNAL; PROPHYLAXIS; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; SIDE EFFECT; TREATMENT OUTCOME;

EID: 4644231011     PISSN: 11732563     EISSN: None     Source Type: Journal    
DOI: 10.2165/00044011-200424090-00003     Document Type: Article

References (28)

1. Leibowitz HM, Kupferman A. Drug interaction in the eye: concurrent corticosteroid-antibiotic therapy for inflammatory keratitis. Arch Ophthalmol 1977; 95: 682-5
2. Schoenwald RD, Harris RG, Turner D, et al. Ophthalmic bioequivalence of steroid/antibiotic combination formulations. Biophram Drug Dispos 1985; 8: 527-48
3. Leibowitz HM, Pratt MV, Flagstad IJ, et al. Human conjunctivitis. II. Treatment. Arch Ophthalmol 1976; 94: 1752-6
4. Hughes DS, Hill RJ. Infectious endophthalmitis after cataract surgery. Br J Ophthalmol 1994; 78: 227-32
5. Abel R, Abel AD. Perioperative antibiotic, steroid and non-steroidal anti-inflammatory agents in cataract intraocular lens surgery. Curr Opin Ophthalmol 1997; 8: 29-32
6. Jaanus SD. Prevention of postoperative infection: limits and possibilities. Br J Ophthalmol 1996; 80: 681-2
7. Flach AJ. Topical nonsteroidal antiinflammatory drugs in ophthalmology. Int Ophthalmol Clin 2002; 42: 1-11
8. Struck HG, Bariszlovich A. Comparison of 0.1% dexamethasone phosphate eye gel (Dexagel) and 1% prednisolone acetate eye suspension in the treatment of post-operative inflammation after cataract surgery. Graefes Arch Clin Exp Ophthalmol 2001 239: 737-42
9. Holzer MP, Solomon KD, Sandoval HP, et al. Comparison of ketorolac tromethamine 0.5% and loteprednol etabonate 0.5% for inflammation after phacoemulsification: prospective randomized double-masked study. J Cataract Refract Surg 2002; 28: 93-9
10. Papa V, Milazzo G, Santocono M, et al. Naproxen ophthalmic solution to manage inflammation after phacoemulsification. J Cataract Refract Surg 2002; 28: 321-7
11. Solomon KD, Vroman DT, Barker D, et al. Comparison of ketorolac tromethamine 0.5% and rimexolone 1% to control inflammation after cataract extraction: prospective randomized double-masked study. J Cataract Refract Surg 2001; 27: 1232-7
12. Kraff MC, Martin RG, Neumann AC, et al. Efficacy of diclofenac sodium ophthalmic solution versus placebo in reducing inflammation following cataract extraction and posterior chamber lens implantation. J Cataract Refract Surg 1994; 20: 138-44
13. Othenin-Girard PH, Tritten JJ, Pittet N, et al. Dexamethasone versus diclofenac sodium eyedrops to treat inflammation after cataract surgery. J Cataract Refract Surg 1994; 20: 9-11
14. Starr MB. Prophylactic antibiotics for ophthalmic surgery. Surv Ophthalmol 1983; 27: 353-73
15. Stewart RH, Kimbrough RL, Smith JP, et al. Use of steroid/ antibiotic prophylaxis in intraocular lens implantation: a double-masked study vs placebo. Ann Ophthalmol 1983; 15: 24-8
16. Reddy MS, Suneetha N, Thomas RK, et al. Topical diclofenac sodium for treatment of postoperative inflammation in cataract surgery. Indian J Ophthalmol 2000; 48: 223-6
17. Barraquer RI, Álvarez de Toledo JP, Montané D, et al. Fixed-dose combination of 1.1% diclofenac plus 0.3% tobramycin ophthalmic solution for inflammation after cataract surgery: a randomized, comparative, active treatment-controlled trial. Eur J Ophthalmol 1998; 8: 173-8
18. Vidai R, Riu JL, Martínez C, et al. 0.1% diclofenac sodium-0.3% tobramycin eye drops (DT): efficacy and ocular distribution of diclofenac and tobramycin [abstract]. Methods Find Exp Clin Pharmacol 1997; 19 Suppl. A: 191
19. Mohan N, Gupta V, Tandon R, et al. Topical ciprofloxacin-dexamethasone combination therapy after cataract surgery: randomized controlled clinical trial. J Cataract Refract Surg 2001; 27: 1975-8
20. Hugues FC, Le Jeunne C. Systemic and local tolerability of ophthalmic drug formulations. Drug Saf 1993; 8: 365-80
21. Collum L. Expert report on the clinical documentation for TobraDex eye drops, suspension (tobramycin 3 mg/ml and dexamethasone 1 mg/ml). Alcon Internal Document CER-07/03 July 2003: 1-30
22. Janus SD. Prevention of postoperative infection: limits and possibilities. Br J Ophthalmol 1996; 80: 681-2
23. Folkens A, Schlech B, Cupp G, Wilmer Z. Quantitative ocular bacteriology. In: Hyndiuk R, Tabbara K, editors. Infection of the eye. London: Little, Brown & Co, 1996: 85-91
24. Glasser D, Baum J. Antibacterial Agents. In: Hyndiuk R, Tabbara K, editors. Infection of the eye. London: Little, Brown & Co, 1996: 207-231
25. Wilhelmus K, Gilbert M, Osato M. Tobramycin in ophthalmology: survey of ophthalmology. In: Mindel J, Mishima S, editors. Therapeutic Review 1987; 32: 111-22
26. Sawa M. Clinical application of laser flare-cell meter. Jpn J Ophthalmol 1990; 34: 346-63
27. El-Maghraby A, Marzouki A, Matheen TM, et al. Reproducibility and validity of laser flare/cell meter measurements of intraocular inflammation. J Cataract Refract Surg 1993; 19: 52-5
28. Oshika T, Nishi M, Mochizuki M, et al. Quantitative assessment of aqueous flare and cells in uveitis. Jpn J Ophthalmol 1989; 33: 279-87