Reporting of noninferiority and equivalence randomized trials for major prostaglandins: A systematic survey of the ophthalmology literature

Trials

Volumn 9, Issue , 2008, Pages

  Eyawo, Oghenowede ^a   Lee, Chia Wen ^b   Rachlis, Beth ^c   Mills, Edward J ^d  

^a SIMON FRASER UNIVERSITY   (Canada)

^b PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United Kingdom)

^c UNIVERSITY OF TORONTO   (Canada)

^d MCMASTER UNIVERSITY   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

BIMATOPROST; BRIMONIDINE; BRINZOLAMIDE; DORZOLAMIDE; DORZOLAMIDE PLUS TIMOLOL; LATANOPROST; LATANOPROST PLUS TIMOLOL; PILOCARPINE; PROSTAGLANDIN DERIVATIVE; TIMOLOL; TRAVOPROST; UNOPROSTONE ISOPROPYL ESTER;

ARTICLE; CLINICAL PROTOCOL; CLINICAL TRIAL; CONJUNCTIVAL HYPEREMIA; CONTROLLED CLINICAL TRIAL; DATA COLLECTION METHOD; DISEASE SEVERITY; DOSAGE SCHEDULE COMPARISON; DRUG EFFICACY; DRUG MONITORING; EVENING DOSAGE; HUMAN; INTRAOCULAR HYPERTENSION; METHODOLOGY; MONOTHERAPY; OPEN ANGLE GLAUCOMA; OPEN STUDY; QUALITATIVE RESEARCH; RANDOMIZED CONTROLLED TRIAL; RESOURCE ALLOCATION; SAMPLE SIZE;

EID: 58249141983     PISSN: 17456215     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-9-69     Document Type: Article

References (71)

1. Piaggio G Elbourne DR Altman DG Pocock SJ Evans SJW Reporting of noninferiority and equivalence randomized trials JAMA 2006, 295:1152-1160. 10.1001/jama.295.10.1152 16522836
2. United States Food and Drug Administration (FDA) Guidance for Industry, E 10, Choice of control group and related issues in clinical trials 2001 http://www.fda.gov/cder/guidance/4155fnl.pdf
3. Gøtzsche PC Lessons from and cautions about noninferiority and equivalence randomized trials JAMA 2006, 295:1172-1174. 10.1001/ jama.295.10.1172 16522840
4. Le Henanff A Giraudeau B Baron G Ravaud P Quality of reporting of noninferiority and equivalence randomized trials JAMA 2006, 295:1147-1151. 10.1001/jama.295.10.1147 16522835
5. Brittain E Lin D A comparison of intent-to-treat and per-protocol results in antibiotic non-inferiority trials Statist Med 2005, 24:1-10. 10.1002/sim.1934
6. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Statistical principles for clinical trials 1998 E9 http://www.ich.org/LOB/media/ MEDIA485.pdf
7. Committee for Proprietary Medicinal Products (CPMP) Points to consider on switching between superiority and non-inferiority 2000 http://www.emea.europa.eu/pdfs/human/ewp/048299en.pdf
8. Ebbutt AF Frith L Practical issues in equivalence trials Statist Med 1998, 17:1691-1701. 10.1002/(SICI)1097-0258(19980815/30)17:15/ 16<1691::AID-SIM971>3.0.CO;2-J
9. Meade MO Guyatt GH Cook RJ Groll R Kachura JR Wigg M Cook DJ Stutsky AS Stewart TE Agreement between alternative classifications of acute respiratory distress syndrome Am J Respir Crit Care Med 2001, 163:490-493. 11179128
10. Jaynes ET Confidence intervals vs. Bayesian intervals Foundations of Probability Theory, Statistical Inference, and Statistical Theories of Science Dordrecht: D. Reidel Harper WL, Hooker CA 1976
11. Gandolfi S Simmons ST Sturm R Chen K Van Denburgh AM for the Bimatoprost Study Group Three-month comparison of bimatoprost and latanoprost in patients with glaucoma and ocular hypertension Adv Ther 2001, 18:110-121. 10.1007/BF02850299 11571823
12. Parrish RK Palmberg P Sheu WP for the XLT Study Group A comparison of latanoprost, bimatroprost, and travoprost in patients with elevated intraocular pressure: A 12-week, randomized, masked-evaluator multicenter study Am J Ophthalmol 2003 135 688 703 10.1016/ S0002-9394(03)00098-9 12719078
13. Zimmerman T Stewart WC for the Latanoprost Axis Study Group Intraocular pressure, safety, and quality of life in glaucoma patients switching to latanoprost from monotherapy treatments J Ocul Pharmacol Ther 2003, 19:405-15. 10.1089/108076803322472971 14583133
14. Noecker RS Dirks MS Choplin NT Berstein P Batoosingh AL Whitcup SM for the Bimatoprost/Latanoprost Study Group A six-month randomized clinical trial comparing the intraocular pressure-lowering efficacy of bimatoprost and latanoprost in patients with ocular hypertension or glaucoma Am J Ophthalmol 2003, 135:55-63. 10.1016/S0002-9394(02)01827-5 12504698
15. DuBiner H Cooke D Dirks M Stewart WC Van Denburgh AM Felix C Efficacy and safety of bimatoprost in patients with elevated intraocular pressure: A 30-day comparison with latanoprost Surv Ophthalmol 2001, 44:S353-360. 10.1016/S0039-6257(01)00212-0
16. Whitcup SM Cantor LB Van Denburgh AM Chen K A randomized, double-masked, multicentre clinical trial comparing bimatoprost and timolol for the treatment of glaucoma and ocular hypertension Br J Ophthalmol 2003, 87:57-62. 1771463 12488264 10.1136/bjo.87.1.57
17. Cohen JS Gross RL Cheetham J Van Denburgh AM Bernstein P Whitcup SM Two-year double-masked comparison of bimatoprost with timolol in patients with glaucoma or ocular hypertension Surv Opthalmol 2004, 49:S45-52. 10.1016/j.survophthal.2003.12.019
18. Higginbotham EJ Schuman JS Goldberg I Gross RL Van Denburgh AM Chen K Whitcup SM for the Bimatoprost Study Groups 1 and 2 One-year randomized study comparing bimatoprost and timolol in glaucoma and ocular hypertension Arch Ophthalmol 2002, 120:1286-1293. 12365906
19. Brandt JD Van Denburgh AM Chen K Whitcup SM for the Bimatoprost Study Group Comparison of once- or twice-daily bimatoprost with twice-daily timolol in patients with elevated IOP: A 3-month clinical trial Ophthalmology 2001, 108(6):1023-1031. 10.1016/S0161-6420(01)00584-X 11382623
20. Brittain CJ Saxena R Waldock A Prospective comparative switch study from timolol 0.5% and latanoprost 0.005% to bimatoprost 0.03% Adv Ther 2006, 23:68-73. 10.1007/BF02850348 16644608
21. Day DG Sharpe ED Beischel CJ Jenkins JN Stewart JA Stewart WC Safety and efficacy of bimatoprost 0.03% versus timolol maleate 0.5%/dorzolamide 2% fixed combination Eur J Ophthalmol 2005, 15:336-342. 15945001
22. Coleman AL Lerner F Bernstein P Whitcup SM A 3-month randomized controlled trial of bimatoprost (LUMIGAN) versus combined timolol and dorzolamide (COSOPT) in patients with glaucoma or ocular hypertension Ophthalmol 2003, 110:2362-2368.
23. Netland PA Landry T Sullivan EK Andrew R Silver L Weiner A Mallick S Dickerson J Bergamini MV Robertson SM Davis SS for the Travoprost Study Group Travoprost compared with latanoprost and timolol in patients with open-angle glaucoma or ocular hypertension Am J Ophthalmol 2001, 132:472-484. 10.1016/S0002-9394(01)01177-1 11589866
24. Larsson LI Intraocular pressure of 24 hours after repeated administration of latanoprost 0.0055 or timolol gel-forming solution 0.5% in patients with ocular hypertension Ophthalmology 2001, 108(8):1439-1444. 10.1016/S0161-6420(01)00605-4 11470697
25. Tomita G Araie M Ktazawa Y Tsukhara S A three-year prospective, randomized and open comparison between latanoprost and timolol in Japanese normal-tension glaucoma patients Eye 2004, 18:984-989. 10.1038/ sj.eye.6701373 15037889
26. Watson P Stjernschantz J A six-month, randomized, double-masked study comparing latanoprost with timolol in open-angle glaucoma and ocular hypertension Ophthalmology 1996, 103(1):126-137. 8628543
27. Konstas AG Maltezos AC Gandi S Hudgins AC Stewart WC Comparison of 24-hour intraocular pressure reduction with two dosing regimens of latanoprost and timolol maleate in patients with primary open-angle glaucoma Am J Ophthalmol 1999, 128:15-20. 10.1016/S0002-9394(99)00073-2 10482089
28. Thomas R Parikh R Muliyil J George R Paul P Abraham LM Comparison between latanoprost and brimonidine efficacy and safety in Indian eyes Indian J Ophthalmol 2003, 51:123-128. 12831141
29. Konstas AG Karabatsas CH Lallos N Georgiadis N Kotsimpou A Stewart JA Stewart WC 24-hour intraocular pressures with brmonidine purite versus dorzomalide added to latanoprost in primary open-angle glaucoma subjects Ophthalmology 2005, 112(4):603-608. 10.1016/j.ophtha.2004.11.032 15808251
30. Simmons ST Earl ML for the Alphagan/Xalatan Study Group Three-month comparison of brimonidine and latanoprost as adjunctive therapy in glaucoma and ocular hypertension patients uncontrolled on beta-blockers; tolerance and peak intraocular pressure lowering Ophthalmology 2002, 109(2):307-314. 10.1016/S0161-6420(01)00936-8 11825814
31. Shin DH Feldman RM Sheu WP for the Fixed Combination Latanoprost/Timolol Study Group Efficacy and safety of the fixed combinations latanoprost/ timolol versus drozolamide/timolol in patients with elevated intraocular pressure Ophthalmology 2004, 111(2):276-282. 10.1016/ j.ophtha.2003.05.019 15019375
32. Konstas AG Kozobolis VP Lallos N Christodoulakis E Stewart JA Stewart WC Daytime diurnal curve comparison between the fixed combinations of latanoprost 0.005%/timolol maleate 0.5% and dorzomalide 2%/timolol maleate 0.5% Eye 2004, 18:1264-1269. 10.1038/sj.eye.6701446 15218522
33. Pfeiffer N for the European Latanoprost Fixed Combination Study Group A comparison of the fixed combination of latanoprost and timolol with its individual components Graefes Arch Clin Exp Ophthalmol 2002, 240:893-899. 10.1007/s00417-002-0553-0 12486510
34. Higginbotham EJ Feldman RJ Stiles M Dubiner H for the Fixed Combination Investigative Group Latanaprost and timolol combination therapy vs. monotherapy: One year randomized trial Arch Ophthalmol 2002, 120:915-922. 12096962
35. Diestelhorst M Larsson LI for the European-Canadian Latanoprost Fixed Combination Study Group A 12-week, randomized, double-masked, multicenter study of the fixed combination of latanoprost and timolol in the evening versus individual components Ophthalmology 2006, 113(1):70-76. 10.1016/j.ophtha.2005.06.027 16263174
36. Diestelhorst M Larrson LI for the European Latanoprost Fixed Combination Study Group A 12 week study comparing the fixed combination of latanprost and timolol with the concomitant use of the individual components in patients with open angle glaucoma and ocular hypertension Br J Ophthalmol 2004, 88:199-203. 1771993 14736774 10.1136/ bjo.2003.018234
37. Konstas AG Kozobolis VP Katsimpris IE Boboridis K Koukoula S Jenkins JN Stewart WC Efficacy and safety of latanoprost versus travoprost in exfoliative glaucoma patients Ophthalmology 2007, 114(4):653-657. 10.1016/j.ophtha.2006.07.064 17197028
38. Goldberg I Cunha-Vaz J Jakobsen JE Nordmann JP Trost E Sullivan EK for the International Travoprost Study Group Comparison of topical travoprost eye drops given once daily and timolol 0.5% given twice daily in patients with open-angle glaucoma or ocular hypertension J Glaucoma 2001, 10:414-422. 10.1097/00061198-200110000-00010 11711841
39. Franks WA Renard JP Cunlife IA Rojanapongpun P A 6-week, double-masked, parallel-group study of the efficacy and safety of travoprost 0.004% compared with latanoprost 0.005%/timolol 0.5% in patients with primary open-angle glaucoma or ocular hypertension Clin Ther 2006, 28:332-339. 10.1016/j.clinthera.2006.03.001 16750448
40. Topouzis F Melamed S Danesh-Meyer H Wells AP Kozobolis V Wieland H Andrew R Wells D A 1-year study to compare the efficacy and safety of once-daily travoprost 0.004%/timolol 0.5% to once-daily latanoprost 0.005%/timolol 0.5% in patients with open-angle glaucoma or ocular hypertension Eur J Ophthalmol 2007, 17:183-190. 17415690
41. Hughes BA Bacharach J Craven ER Kaback MB Mallick S Landry TA Bergamini MV A three-month, multicenter, double-masked study of the safety and efficacy of travoprost 0.004%/timolol 0.5% ophthalmic solution compared to travoprost 0.004% ophthalmic solution and timolol 0.5% dosed concomitantly in subjects with open-angle glaucoma or ocular hypertension J Glaucoma 2005, 14:392-299. 10.1097/ 01.ijg.0000176935.08392.14 16148589
42. Fechtner RD Airaksinen PJ Getson AJ Lines CR Adamsons IA for the COSOPT versus XALATAN Study Groups Efficacy and tolerability of the dorzolamide 2%/timolol 0.5% combination (COSOPT) versus 0.005% (XALATAN) in the treatment of ocular hypertension or glaucoma: Results from two randomized clinical trials Acta Ophthalmol Scand 2004, 82:42-48. 10.1046/ j.1600-0420.2004.0205.x 14982045
43. Hommer A A double-masked randomized parallel comparison of a fixed combination of bimatoprost 0.03%/timolol 0.5% with non-fixed Eur J Ophthalmol 2007, 17:53-62. 17294383
44. Holló G Chiselita D Petkova N Cvenkel B Liehneova I Izgi B Berta A Szaflik J Turacli E Stewart WC The efficacy and safety of timolol maleate versus brinzolamide each given twice daily added to travoprost in patients with ocular hypertension or primary open-angle glaucoma Eur J Ophthalmol 2006, 16:816-823. 17191187
45. Netland PA Mroz M Rosner SA Katzman B Macy JI Brimonidine purite and bimatoprost compared with timolol and latanoprost in patients with glaucoma and ocular hypertension Adv Ther 2003, 20:20-30. 10.1007/ BF02850116 12772815
46. Stewart WC Stewart JA Day DG Sharpe ED Jenkins JN Efficacy and safety of the latanoprost/timolol maleate fixed combination vs concomitant brimonidine and latanoprost therapy Eye 2004, 18:990-995. 10.1038/ sj.eye.6701375 15037890
47. Day DG Schacknow PN Wand M Sharpe ED Stewart JA Leech J Stewart WC Timolol 0.5%/dorzolamide 2% fixed combination vs timolol maleate 0.5% and unoprostone 0.15% given twice daily to patients with primary open-angle glaucoma or ocular hypertension Am J Ophthalmol 2003, 135:138-143. 10.1016/S0002-9394(02)01887-1 12566015
48. Sharpe ED Henry CJ Mundorf TK Day DG Stewart JA Jenkins JN Stewart WC Brimonidine 0.2% vs unoprostone 0.15% both added to timolol maleate 0.5% given twice daily to patients with primary open-angle glaucoma or ocular hypertension Eye 2005, 19:35-40. 10.1038/sj.eye.6701392 15094733
49. Konstas AGP Kozobolis VP Tsironi S Makridaki I Efremova R Stewart WC Comparison of the 24-hour intraocular pressure-lowering effects of latanorpost and dorzolamide/timolol fixed combination after 2 and 6 months of treatment Ophthalmology 2008, 115(1):99-103. 10.1016/ j.ophtha.2007.03.007 18166407
50. Schuman JS Katz GJ Lewis RA Henry JC Mallick S Wells DT Sullivan EK Landry TA Bergamini MVW Robertson SM Efficacy and safety of a fixed combination of travoprost 0.004%/timolol 0.5% ophthalmic solution once daily for open-angle glaucoma or ocular hypertension Am J Ophthalmol 2005, 140:242-250. 16086946
51. Stewart WC Stewart JA Day D Sharpe ED Efficacy and safety of timolol maleate/latanoprost fixed combination versus timolol maleate and brimonidine given twice daily Acta Ophthalmol Scand 2003, 81:242-246. 10.1034/j.1600-0420.2003.00065.x 12780402
52. Honrubia FM Larsson LI Spiegel D the European Latanoprost Study Group A comparison of the effects on intraocular pressure of latanoprost 0.005% and the fixed combination of dorzolamide 2% and timolol 0.5% in patients with open-angle glaucoma Acta Ophthalmol Scand 2002, 80:635-641. 10.1034/ j.1600-0420.2002.800615.x 12485286
53. Susanna R Jr Giampani J Borges AS Vessani RM Jordao MLS A double-masked, randomized clinical trial comparing latanoprost with unoprostone in patients with open-angle glaucoma or ocular hypertension Ophthalmol 2001, 108:259-263.
54. Diestelhorst M for the German Latanoprost Study Group The additive intraocular pressure-lowering effect of latanoprost 0.005% daily once and pilocarpine 2% t.i.d. in patients with open-angle glaucoma or ocular hypertension. A 6-month, randomized, multicenter study Graef Arch Clin Exp Ophthalmol 2000, 238:433-439. 10.1007/s004170050375
55. Stewart WC Day DG Sharpe ED Dubiner HB Holmes KT Stewart JA Efficacy and safety of timolol solution once daily vs timolol gel added to latanoprost Am J Ophthalmol 1999, 128:692-696. 10.1016/ S0002-9394(99)00237-8 10612504
56. Petounis A Mylopoulos N Kandarakis A Andreanos D Dimitrakoulias N Comparison of the additive intraocular pressure-lowering effect of latanoprost and dorzolamide when added to timolol in patients with open-angle glaucoma or ocular hypertension: A randomized, open-label, multicenter study in Greece J Glaucoma 2001, 10:316-324. 10.1097/ 00061198-200108000-00012 11558817
57. Konstas AGP Nakos E Tersis I Lallos NA Leech JN Stewart WC A comparison of once-daily morning vs evening dosing of concomitant latanoprost/ timolol Am J Ophthalmol 2002, 133:753-757. 10.1016/S0002-9394(02)01460-5 12036665
58. Hopewell S Altman DG Moher D Schulz KF Endorsement of the CONSORT Statement by high impact factor medical journals: A survey of journal editors and journal 'Instructions to Authors' Trials 2008, 9:20. 2359733 18423021 10.1186/1745-6215-9-20
59. Devereaux PJ Choi PT El-Dika S Bhandari M Montori VM Schünemann HJ Garg AX Busse JW Heels-Ansdell D Ghali WA Manns BJ Guyatt GH An observational study found that authors of randomized controlled trials frequently use concealment of randomization and blinding, despite the failure to report these methods J Clin Epidemiol 2004, 57:1232-1236. 10.1016/j.jclinepi.2004.03.017 15617948
60. Plint AC Moher D Morrison A Schulz KF Altman DG Hill C Gaboury I Does the CONSORT checklist improve the quality of reports of randomized controlled trials: A systematic review Medical Journal of Australia 2006, 185:263-267. 16948622
61. Wiens BL Zhao W The role of intention-to-treat in analysis of noninferiority studies Clin Trials 2007, 4:286-291. 10.1177/ 1740774507079443 17715258
62. Mills E Wu P Gagnier J Heels-Ansdell D Montori VM An analysis of general medical and specialist journals that endorse CONSORT found that reporting was not enforced consistently J Clin Epidemol 2005, 58:662-667. 10.1016/j.jclinepi.2005.01.004
63. McNamee D Horton R Lies, damn lies, and reports of RCTs Lancet 1996, 348:562. 10.1016/S0140-6736(05)64795-2 8774566
64. Kaufman R The prostaglandin wars Am J Ophthalmol 2003, 136:727-728. 10.1016/S0002-9394(03)00658-5 14516814
65. Eisenberg D Randomized clinical trial comparing intraocular pressure-lowering efficacy of bimatoprost and latanoprost in patients with ocular hypertension or glaucoma Am J Ophthalmol 2003, 136:217. 10.1016/S0002-9394(03)00195-8 12834708
66. Tinmouth JM Steele LS Tomlinson G Glazier RH Are claims of equivalency in digestive diseases trials supported by the evidence? Gastroenterol 2004, 126:1700-1710. 10.1053/j.gastro.2004.03.005
67. Krysan DJ Kemper AR Claims of equivalence in randomized controlled trials of the treatment of bacterial meningitis in children Pediatr Infect Dis J 2002, 21:753-758. 10.1097/00006454-200208000-00011 12192164
68. Greene WL Concato J Feinstein AR Claims of equivalence in medical research: Are they supported by the evidence? Ann Intern Med 2000, 132:715-722. 10787365
69. McAlister FA Sackett DL Active-control equivalence trials and antihypertensive agents Am J Med 2001, 111:553-558. 10.1016/ S0002-9343(01)00900-7 11705432
70. Parienti JJ Verdon R Massari V Methodological standards in non-inferiority AIDS trials: Moving from adherence to compliance BMC Med Res Methodol 2006, 6:46. 1592102 16987409 10.1186/1471-2288-6-46
71. Weins BL Choosing an equivalence limit for non-inferiority or equivalence studies Control Clin Trials 2002, 23:2-14. 10.1016/ S0197-2456(01)00196-9 11852160