Randomized clinical trial of the efficacy and safety of preservative-free tafluprost and timolol in patients with open-angle glaucoma or ocular hypertension

American Journal of Ophthalmology

Volumn 153, Issue 6, 2012, Pages 1187-1196

  Chabi, Almira ^a   Varma, Rohit ^b   Tsai, James C ^c   Lupinacci, Robert ^a   Pigeon, Joseph ^d   Baranak, Christine ^a   Noble, Liliane ^a   Lines, Christopher ^a   Ho, Tony W ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

^b UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^c YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d VILLANOVA UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIMATOPROST; BRINZOLAMIDE; DORZOLAMIDE; LATANOPROST; TAFLUPROST; TIMOLOL; TRAVOPROST;

ADULT; ARTICLE; BLURRED VISION; COLITIS; CONJUNCTIVAL HYPEREMIA; CONTROLLED STUDY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFECT; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; EVENING DOSAGE; EYE IRRITATION; EYE PAIN; FEMALE; FRACTURE; HEADACHE; HEART ATRIUM FIBRILLATION; HEART INFARCTION; HERNIA; HUMAN; INTRAOCULAR HYPERTENSION; INTRAOCULAR PRESSURE; JOINT DISLOCATION; KERATITIS; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; MORNING DOSAGE; MULTICENTER STUDY; OCULAR PRURITUS; OPEN ANGLE GLAUCOMA; PATIENT COMPLIANCE; PHOTOPHOBIA; PRIORITY JOURNAL; RETINA DETACHMENT; TENDON RUPTURE; TREATMENT DURATION; VISUAL ACUITY;

ANTIHYPERTENSIVE AGENTS; DOUBLE-BLIND METHOD; FEMALE; GLAUCOMA, OPEN-ANGLE; HUMANS; INTRAOCULAR PRESSURE; MALE; MIDDLE AGED; OCULAR HYPERTENSION; OPHTHALMIC SOLUTIONS; PRESERVATIVES, PHARMACEUTICAL; PROSTAGLANDINS F; TIMOLOL; TONOMETRY, OCULAR; TREATMENT OUTCOME; VISUAL ACUITY;

EID: 84861193144     PISSN: 00029394     EISSN: 18791891     Source Type: Journal    
DOI: 10.1016/j.ajo.2011.11.008     Document Type: Article

References (34)

1. C. Costagliola, R. dell'Omo, M.R. Romano Pharmacotherapy of intraocular pressure - part II Carbonic anhydrase inhibitors, prostaglandin analogues and prostamides Expert Opin Pharmacother 10 17 2009 2859 2870
2. C.B. Toris, B.T. Gabelt, P.L. Kaufman Update on the mechanism of action of topical prostaglandins for intraocular pressure reduction Surv Ophthalmol 53 Suppl 1 2008 S107 S120
3. C. Costagliola, R. dell'Omo, M.R. Romano Pharmacotherapy of intraocular pressure: part I Parasympathomimetic, sympathomimetic and sympatholytics Expert Opin Pharmacother 10 16 2009 2663 2677
4. C.A. Webers, H.J. Beckers, M.P. Zeegers The intraocular pressure-lowering effect of prostaglandin analogs combined with topical β-blocker therapy: a systematic review and meta-analysis Ophthalmology 117 11 2010 2067 2074.e1-6
5. J.W. Cheng, Y. Li, R.L. Wei Systematic review of intraocular pressure-lowering effects of adjunctive medications added to latanoprost Ophthalmic Res 42 2 2009 99 105
6. R. Tabet, W.C. Stewart, R. Feldman, A.G. Konstas A review of additivity to prostaglandin analogs: fixed and unfixed combinations Surv Ophthalmol 53 Suppl 1 2008 S85 S92
7. S.S. Patel, C.M. Spencer Latanoprost A review of its pharmacological properties, clinical efficacy and tolerability in the management of primary open-angle glaucoma and ocular hypertension [Review] Drugs Aging 9 5 1996 363 378
8. A. Alm, I. Grierson, M.B. Shields Side effects associated with prostaglandin analog therapy Surv Ophthalmol 53 Suppl 1 2008 S93 S105
9. R. Susanna Jr, P. Chew, Y. Kitazawa Current status of prostaglandin therapy: latanoprost and unoprostone Surv Ophthalmol 47 Suppl 1 2002 S97 S104
10. M.P. Curran Bimatoprost: a review of its use in open-angle glaucoma and ocular hypertension Drugs Aging 26 12 2009 1049 1071
11. J.T. Whitson Travoprost - a new prostaglandin analogue for the treatment of glaucoma Expert Opin Pharmacother 3 7 2002 965 977
12. N.L. Burstein Corneal cytotoxicity of topically applied drugs, vehicles and preservatives Surv Ophthalmol 25 1 1980 15 30
13. C. Baudouin Detrimental effect of preservatives in eyedrops: implications for the treatment of glaucoma Acta Ophthalmol 86 7 2008 716 726
14. P.J. Pisella, P. Pouliquen, C. Baudouin Prevalence of ocular symptoms and signs with preserved and preservative free glaucoma medication Br J Ophthalmol 86 4 2002 418 423
15. A. Hommer A review of preserved and preservative-free prostaglandin analogues for the treatment of open-angle glaucoma and ocular hypertension Drugs Today (Barc) 46 6 2010 409 416
16. J. Hong, L. Bielory Allergy to ophthalmic preservatives Curr Opin Allergy Clin Immunol 9 5 2009 447 453
17. Merck & Co., Inc TIMOPTIC® (timolol maleate) preservative free sterile ophthalmic solution Prescribing information 2005 Merck Whitehouse Station, NJ http://www.merck.com/product/usa/pi-circulars/ Accessed: April 11, 2011
18. A. Shedden, I.A. Adamsons, A.J. Getson Comparison of the efficacy and tolerability of preservative-free and preservative-containing formulations of the dorzolamide/timolol fixed combination(COSOPT©)in patients with elevated intraocular pressure in a randomized clinical trial Graefes Arch Clin Exp Ophthalmol 248 12 2010 1757 1764
19. Y. Takagi, T. Nakajima, A. Shimazaki Pharmacological characteristics of AFP-168 (tafluprost), a new prostanoid FP receptor agonist, as an ocular hypotensive drug Exp Eye Res 78 4 2004 767 776
20. M. Aihara Clinical appraisal of tafluprost in the reduction of elevated intraocular pressure (IOP) in open-angle glaucoma and ocular hypertension Clin Ophthalmol 4 2010 163 170
21. D. Pozarowska Safety and tolerability of tafluprost in treatment of elevated intraocular pressure in open-angle glaucoma and ocular hypertension Clin Ophthalmol 4 2010 1229 1236
22. H. Uusitalo, E. Chen, N. Pfeiffer Switching from a preserved to a preservative-free prostaglandin preparation in topical glaucoma medication Acta Ophthalmol 88 3 2010 329 336
23. E. Egorov, A. Ropo Investigators Adjunctive use of tafluprost with timolol provides additive effects for reduction of intraocular pressure in patients with glaucoma Eur J Ophthalmol 19 2 2009 214 222
24. C.E. Traverso, A. Ropo, M. Papadia, H. Uusitalo A phase II study on the duration and stability of the intraocular pressure-lowering effect and tolerability of tafluprost compared with latanoprost J Ocul Pharmacol Ther 26 1 2010 97 104
25. H. Uusitalo, L.E. Pillunat, A. Ropo Phase III Study Investigators Efficacy and safety of tafluprost 0.0015% versus latanoprost 0.005% eye drops in open-angle glaucoma and ocular hypertension: 24-month results of a randomized, double-masked phase III study Acta Ophthalmol 88 1 2010 12 19
26. T. Hamacher, J. Airaksinen, V. Saarela Efficacy and safety levels of preserved and preservative-free tafluprost are equivalent in patients with glaucoma or ocular hypertension: results from a pharmacodynamics analysis Acta Ophthalmol Suppl (Oxf) 242 2008 14 19
27. A.G. Konstas, N. Mylopoulos, C.H. Karabatsas Diurnal intraocular pressure reduction with latanoprost 0.005% compared to timolol maleate 0.5% as monotherapy in subjects with exfoliation glaucoma Eye (Lond) 18 9 2004 893 899
28. K.S. Rathore, R.K. Nema, S.S. Sisodia Timolol maleate a gold standard drug in glaucoma used as ocular film ans inserts: an overview International Journal of Pharmaceutical Sciences Review and Research 3 1 2010 23 29
29. R. Van der Valk, C.A. Webers, J.S. Schouten, M.P. Zeegers, F. Hendrikse, M.H. Prins Intraocular pressure-lowering effects of all commonly used glaucoma drugs: a meta-analysis of randomized clinical trials Ophthalmology 112 7 2005 1177 1185
30. O. Miettinen, M. Nurminen Comparative analysis of two rates Stat Med 4 2 1985 213 226
31. H.K. Mishima, K. Masuda, Y. Kitazawa A comparison of latanoprost and timolol in primary open-angle glaucoma and ocular hypertension A 12-week study Arch Ophthalmol 114 8 1996 929 932
32. R.K. Parrish, P. Palmberg, W.P. Sheu XLT Study Group A comparison of latanoprost, bimatoprost, and travoprost in patients with elevated intraocular pressure: a 12-week, randomized, masked-evaluator multicenter study Am J Ophthalmol 135 5 2003 688 703
33. E.J. Higginbotham, K.W. Olander, E.E. Kim Fixed combination of latanoprost andtimolol vs. individual components for primary open-angle glaucoma or ocular hypertension: a randomized, double-masked study Arch Ophthalmol 128 2 2010 165 172
34. H. Uusitalo, K. Kaarniranta, A. Ropo Pharmacokinetics, efficacy and safety profiles of preserved and preservative-free tafluprost in healthy volunteers Acta Ophthalmol Suppl (Oxf) 242 2008 7 13