Relative efficacy and safety of preservative-free latanoprost (T2345) for the treatment of open-angle glaucoma and ocular hypertension – an adjusted indirect comparison meta-analysis of randomised clinical trials

Michel Cucherat, Ingeborg Stalmans, Jean-François Rouland

WEB supplement –Bibliographic references of trial included in the meta-analysis

  1. Alagoz G, Gürel K, Bayer A, et al. A comparative study of bimatoprost and travoprost: effect on intraocular pressure and ocular circulation in newly diagnosed glaucoma patients.Ophthalmologica 2008;222:88-95.
  2. Allergan study. Safety and Efficacy Study of Different Formulations of Bimatoprost Once-Daily in Patients With Glaucoma or Ocular Hypertension. Study No. 192024-030 (study identifier: NCT00652496). accessed on July 1st 2012.
  3. Birt CM, Buys YM, Ahmed II, et al; Toronto Area Glaucoma Society. Prostaglandin efficacy and safety study undertaken by race (the PRESSURE study).J Glaucoma 2010;19:460-7.
  4. Cantor LB, WuDunn D, Cortes A, et al. Ocular hypotensive efficacy of bimatoprost 0.03% and travoprost 0.004% in patients with glaucoma or ocular hypertension.Surv Ophthalmol 2004;49:S12-8.
  5. Cantor LB, Hoop J, Morgan L, et al; Bimatoprost-Travoprost Study Group. Intraocular pressure-lowering efficacy of bimatoprost 0.03% and travoprost 0.004% in patients with glaucoma or ocular hypertension.Br J Ophthalmol 2006;90:1370-3.
  6. Cardascia N, Vetrugno M, Trabucco T, et al. Effects of travoprost eye drops on intraocular pressure and pulsatile ocular blood flow: a 180-day, randomized, double-masked comparison with latanoprost eye drops in patients with open-angle glaucomaCurr Ther Res 2003;64:389-400.
  7. Faridi UA, Saleh TA, Ewings P, et al. Comparative study of three prostaglandin analogues in the treatment of newly diagnosed cases of ocular hypertension, open-angle and normal tension glaucoma.Clin Experiment Ophthalmol 2010;38:678-82.
  8. Gandolfi S, Simmons ST, Sturm R, et al; Bimatoprost Study Group 3. Three-month comparison of bimatoprost and latanoprost in patients with glaucoma and ocular hypertension. Adv Ther 2001;18:110-21.
  9. Gandolfi S, Paredes T, Goldberg I, et al; Travoprost Bak-Free Clinical Study Group. Comparison of a travoprost BAK-free formulation preserved with polyquaternium-1 with BAK-preserved travoprost in ocular hypertension or open-angle glaucoma. Eur J Ophthalmol 2012;22:34-44.
  10. Katz LJ, Cohen JS, Batoosingh AL, et al. Twelve-month, randomized, controlled trial of bimatoprost 0.01%, 0.0125%, and 0.03% in patients with glaucoma or ocular hypertension. Am J Ophthalmol 2010;149:661-671.
  11. Koz OG, Ozsoy A, Yarangumeli A, et al. Comparison of the effects of travoprost, latanoprost and bimatoprost on ocular circulation: a 6-month clinical trial. Acta Ophthalmol Scand 2007;85:838-43.
  12. Lewis RA, Katz GJ, Weiss MJ, et al; Travoprost BAC-free Study Group. Travoprost 0.004% with and without benzalkonium chloride: a comparison of safety and efficacy. J Glaucoma 2007;16:98-103.
  13. Macky TA. Bimatoprost versus travoprost in an Egyptian population: a hospital-based prospective, randomized study. J Ocul Pharmacol Ther 2010;26:605-10.
  14. Netland PA, Landry T, Sullivan EK, et al; Travoprost Study Group. Travoprost compared with latanoprost and timolol in patients with open-angle glaucoma or ocular hypertension. Am J Ophthalmol 2001;132:472-84.
  15. Noecker RS, Dirks MS, Choplin NT, et al; 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.
  16. Noecker RJ, Earl ML, Mundorf TK, et al. Comparing bimatoprost and travoprost in black Americans. Curr Med Res Opin 2006;22:2175-80.
  17. Parrish RK, Palmberg P, Sheu WP; 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 2003;135:688-703.
  18. Uusitalo H, Pillunat LE, Ropo A; 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 2010;88:12-9.
  19. Yildirim N, Sahin A, Gultekin S. The effect of latanoprost, bimatoprost, and travoprost on circadian variation of intraocular pressure in patients with open-angle glaucoma.J Glaucoma 2008;17:36-9.
  20. Zhong Y, Shen X, Yu J, et al. The comparison of the effects of latanoprost, travoprost, and bimatoprost on central corneal thickness.Cornea 2011;30:861-4.
  21. Friedman DS, Hahn SR, Gelb L, et al. Doctor-patient communication, health-related beliefs, and adherence in glaucoma results from the Glaucoma Adherence and Persistency Study. Ophthalmology 2008;115:1320-7.
  22. Hollo G. The side effects of prostaglandin analogues. Expert Opin Drug Saf 2007;6:45-52.
  23. Feldman RM. Conjunctival hyperemia and the use of topical prostaglandins in glaucoma and ocular hypertension. J Ocul Pharmacol Ther 2003;19:23-35.
  24. Rouland JF, Traverso CE, Stalmans I, Fekih LE, Delval L, Renault D, et al. Efficacy and safety of preservative-free latanoprost eyedrops, compared with BAK-preserved latanoprost in patients with ocular hypertension or glaucoma. Br J Ophthalmol. 2013;97:196-200.

Web supplement – List of excluded trial

Table Supl 1 – Excluded trials and reason for exclusion

Trial / Exclusion reason
Arcieri, 2005 [1] / inappropriate comparison and patients (aphakic or pseudophakic patients)
Ang, 2008 [2] / inappropriate patients (newly diagnosed normal tension glaucoma patients)
Aung, 2001 [3] / insufficient duration of treatment (only 1 month)
Bron, 2004 [4] / inappropriate treatment comparison (timolol)
Chen, 2007 [5] / inappropriate patients (chronic angle-closure glaucoma)
Chiselita, 2005 [6] / cross over without washout
Diestelhorst, 2000 [7] / non relevant treatment comparison (versus pilocarpine)
Dirks, 2006 [8] / irelevant patients (normal-tension glaucoma)
DuBiner, 2001 [9] / insufficient treatment duration (29 days)
DuBiner, 2004 [10] / insufficient treatment duration (2 weeks)
Gandolfi, 2003 [11] / insufficient treatment duration (30 days instead 2 months)
García-Feijoo, 2006 [12] / insufficient treatment duration (24h)
Goldberg, 0 [13] / not a RCT (open-label safety surveillance study )
Gross, 2008 [14] / treatment duration too short (2 weeks instead of at least 2 months)
Hamacher, 2008 [15] / insufficient treatment duration (1 month)
Hepsen (bimatoprost), 2007 [16] / inappropriate patients (exfoliation syndrome and occular hypertension)
Hepsen (travoprost), 2007 [17] / inappropriate patients (exfoliation syndrome and occular hypertension)
How, 2009 [18] / no washout (patients previously treated)
Jampel, 2002 [19] / treatment withdrawn from the market (unoprostone)
Katz (0.0125%), 2010 [20] / treatment withdrawn from the market (bimatoprost 0.0125%)
Kobayashi, 2001 [21] / comparison between eyes not between patients
Konstas, 2005 [22] / insufficient treatment duration (24h)
Konstas, 2007 [23] / not appropriate patients (exfoliative glaucoma)
Konstas, 2007 [24] / not appropriate patients (exfoliative glaucoma)
Maul, 2007 [25] / insufficient duration (6 weeks)
Narayanaswamy, 0 [26] / no washout between the 2 periods
Netland (travoprost 0.0015%), 2001 [27,28] / inappropriate treatment (travoprost 0.0015%)
Noecker b, 2003 [29] / probably included in trial of 2006 (it is a pilot study)
Orzalesi (bimatoprost), 2006 [30] / insufficient treatment duration (1 month)
Parmaksiz, 2006 [31] / inappropriate patients (patients with pseudoexfoliation glaucoma)
Realini, 2009 [32] / objective not appropriate: to evaluate the clinical value of the monocular therapeutic drug trial in predicting long-term intraocular pressure reduction
Saito, 2001 [33] / insufficient duration of monotherapy (6 weeks)
Sponsel, 2002 [34] / insufficient treatment duration (1 month instead 2 months)
Stewart, 2001 [35] / inappropriate treatment comparison (add on latanoprost 0.005%)
Susanna, 2001 [36] / treatment withdrawn from the market (unoprostone)
Topouzis, 2007 [37] / treatment comparison not appropriate (association with timolol)
Traverso, 2010 [38] / duration insufficient (43 days, <2 months)
Tsukamoto, 2002 [39] / treatment withdrawn from the market (isopropyl unoprostone)
Walters, 2004 [40,41] / inappropriate treatment duration (1 month)
Whitson (bimatoprost), 2010 [42] / previously treated patients and still treated with latanoprost at inclusion and baseline (no washout)
Whitson (travoprost), 2010 [43] / previously treated patients and still treated with latanoprost at inclusion and baseline (no washout)

Excluded trials - References

1) Arcieri ES, Santana A, Rocha FN, Guapo GL, Costa VP Blood-aqueous barrier changes after the use of prostaglandin analogues in patients with pseudophakia and aphakia: a 6-month randomized trial. Arch Ophthalmol 2005;123:186-92 [15710814]

2) Ang GS, Kersey JP, Shepstone L, Broadway DC, The effect of travoprost on daytime intraocular pressure in normal tension glaucoma: a randomised controlled trial. Br J Ophthalmol 2008;92:1129-33. [18511540]

3) Aung T, Chew PT, Yip CC, Chan YH, See JL, Khng CG, Hoh ST, Ng LH, Lee HM, A randomized double-masked crossover study comparing latanoprost 0.005% with unoprostone 0.12% in patients with primary open-angle glaucoma and ocular hypertension. Am J Ophthalmol 2001;131:636-42. [11336940]

4) Bron A, Velasque L, Rebica H, Pouliquen P, Elena PP, Rouland JF [Comparison of once-daily nonpreserved timolol and timolol maleate gel-forming solution associated with latanoprost]. J Fr Ophtalmol 2004;27:971-7 [15557857]

5) Chen MJ, Chen YC, Chou CK, Hsu WM, Comparison of the effects of latanoprost and bimatoprost on intraocular pressure in chronic angle-closure glaucoma. J Ocul Pharmacol Ther 2007;23:559-66. [18001247]

6) Chiseliþã D, Antohi I, Medvichi R, Danielescu C, Comparative analysis of the efficacy and safety of latanoprost, travoprost and the fixed combination timolol-dorzolamide; a prospective, randomized, masked, cross-over design study. Oftalmologia 2005;49:39-45. [16408674]

7) Diestelhorst M, 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. German Latanoprost Study Group. Graefes Arch Clin Exp Ophthalmol 2000;238:433-9. [10901475]

8) Dirks MS, Noecker RJ, Earl M, Roh S, Silverstein SM, Williams RD A 3-month clinical trial comparing the IOP-lowering efficacy of bimatoprost and latanoprost in patients with normal-tension glaucoma. Adv Ther 2006;23:385-94 [16912020]

9) DuBiner H, Cooke D, Dirks M, Stewart WC, VanDenburgh AM, Felix C Efficacy and safety of bimatoprost in patients with elevated intraocular pressure: a 30-day comparison with latanoprost. Surv Ophthalmol 2001;45 Suppl 4:S353-60 [11434938]

10) Dubiner HB, Sircy MD, Landry T, Bergamini MV, Silver LH, Darell Turner F, Robertson S, Andrew RM, Weiner A, Przydryga J Comparison of the diurnal ocular hypotensive efficacy of travoprost and latanoprost over a 44-hour period in patients with elevated intraocular pressure. Clin Ther 2004;26:84-91 [14996520]

11) Gandolfi SA, Cimino L, Effect of bimatoprost on patients with primary open-angle glaucoma or ocular hypertension who are nonresponders to latanoprost. Ophthalmology 2003;110:609-14. [12623831]

12) García-Feijoo J, Martínez-de-la-Casa JM, Castillo A, Méndez C, Fernández-Vidal A, García-Sánchez J, Circadian IOP-lowering efficacy of travoprost 0.004% ophthalmic solution compared to latanoprost 0.005%. Curr Med Res Opin 2006;22:1689-97. [16968572]

13) Goldberg I, Li XY, Selaru P, Paggiarino D, A 5-year, randomized, open-label safety study of latanoprost and usual care in patients with open-angle glaucoma or ocular hypertension. Eur J Ophthalmol ;18:408-16. [18465724]

14) Gross RL, Peace JH, Smith SE, Walters TR, Dubiner HB, Weiss MJ, Ochsner KI Duration of IOP reduction with travoprost BAK-free solution. J Glaucoma 2008;17:217-22 [18414108]

15) Hamacher T, Airaksinen J, Saarela V, Liinamaa MJ, Richter U, Ropo A, 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 ) 2008;242:14-9. [18752510]

16) Hepsen IF, Ozkaya E 24-h IOP control with latanoprost, travoprost, and bimatoprost in subjects with exfoliation syndrome and ocular hypertension. Eye (Lond) 2007;21:453-8 [16543930]

17) Hepsen IF, Ozkaya E 24-h IOP control with latanoprost, travoprost, and bimatoprost in subjects with exfoliation syndrome and ocular hypertension. Eye (Lond) 2007;21:453-8 [16543930]

18) How AC, Kumar RS, Chen YM, Su DH, Gao H, Oen FT, Ho CL, Seah SK, Aung T, A randomised crossover study comparing bimatoprost and latanoprost in subjects with primary angle closure glaucoma. Br J Ophthalmol 2009;93:782-6. [19336424]

19) Jampel HD, Bacharach J, Sheu WP, Wohl LG, Solish AM, Christie W, , Randomized clinical trial of latanoprost and unoprostone in patients with elevated intraocular pressure. Am J Ophthalmol 2002;134:863-71. [12470755]

20) Katz LJ, Cohen JS, Batoosingh AL, Felix C, Shu V, Schiffman RM Twelve-month, randomized, controlled trial of bimatoprost 0.01%, 0.0125%, and 0.03% in patients with glaucoma or ocular hypertension. Am J Ophthalmol 2010;149:661-671.e1 [20346780]

21) Kobayashi H, Kobayashi K, Okinami S A comparison of intraocular pressure-lowering effect of prostaglandin F2 -alpha analogues, latanoprost, and unoprostone isopropyl. J Glaucoma 2001;10:487-92 [11740220]

22) Konstas AG, Katsimbris JM, Lallos N, Boukaras GP, Jenkins JN, Stewart WC, Latanoprost 0.005% versus bimatoprost 0.03% in primary open-angle glaucoma patients. Ophthalmology 2005;112:262-6. [15691561]

23) 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;114:653-7. [17197028]

24) Konstas AG, Holló G, Irkec M, Tsironi S, Durukan I, Goldenfeld M, Melamed S, Diurnal IOP control with bimatoprost versus latanoprost in exfoliative glaucoma: a crossover, observer-masked, three-centre study. Br J Ophthalmol 2007;91:757-60. [17124241]

25) Maul E, Carrasco FG, Costa VP, Casiraghi JF, Vargas E, Sarmina JS, Mayol R, A 6-week, multicenter, randomized, double-masked, parallel-group study comparing travoprost 0.004% to latanoprost 0.005% followed by 6-week, open-label treatment with travoprost 0.004%. Clin Ther 2007;29:1915-23. [18035191]

26) Narayanaswamy A, Neog A, Baskaran M, George R, Lingam V, Desai C, Rajadhyaksha V, A randomized, crossover, open label pilot study to evaluate the efficacy and safety of Xalatan in comparison with generic Latanoprost (Latoprost) in subjects with primary open angle glaucoma or ocular hypertension. Indian J Ophthalmol ;55:127-31. [17322603]

27) Halpern MT, Covert DW, Robin AL, Projected impact of travoprost versus both timolol and latanoprost on visual field deficit progression and costs among black glaucoma subjects. Trans Am Ophthalmol Soc 2002;100:109-17; discussion 117-8. [12545683]

28) Netland PA, Landry T, Sullivan EK, Andrew R, Silver L, Weiner A, Mallick S, Dickerson J, Bergamini MV, Robertson SM, Davis AA Travoprost compared with latanoprost and timolol in patients with open-angle glaucoma or ocular hypertension. Am J Ophthalmol 2001;132:472-84 [11589866]

29) Noecker RJ, Earl ML, Mundorf T, Peace J, Williams RD Bimatoprost 0.03% versus travoprost 0.004% in black Americans with glaucoma or ocular hypertension. Adv Ther 2003;20:121-8 [12836812]

30) Orzalesi N, Rossetti L, Bottoli A, Fogagnolo P Comparison of the effects of latanoprost, travoprost, and bimatoprost on circadian intraocular pressure in patients with glaucoma or ocular hypertension. Ophthalmology 2006;113:239-46 [16458092]

31) Parmaksiz S, Yüksel N, Karabas VL, Ozkan B, Demirci G, Caglar Y A comparison of travoprost, latanoprost, and the fixed combination of dorzolamide and timolol in patients with pseudoexfoliation glaucoma. Eur J Ophthalmol 2006;16:73-80 [16496249]

32) Realini TD, A Prospective, randomized, investigator-masked evaluation of the monocular trial in ocular hypertension or open-angle glaucoma. Ophthalmology 2009;116:1237-42. [19576495]

33) Saito M, Takano R, Shirato S, Effects of latanoprost and unoprostone when used alone or in combination for open-angle glaucoma. Am J Ophthalmol 2001;132:485-9. [11589867]

34) Sponsel WE, Paris G, Trigo Y, Pena M, Comparative effects of latanoprost (Xalatan) and unoprostone (Rescula) in patients with open-angle glaucoma and suspected glaucoma. Am J Ophthalmol 2002;134:552-9. [12383812]

35) Stewart WC, Sharpe ED, Stewart JA, Holmes KT, Latham KE, Additive efficacy of unoprostone isopropyl 0.12% (rescula) to latanoprost 0.005%. Am J Ophthalmol 2001;131:339-44. [11239866]

36) Susanna R, Giampani J, Borges AS, Vessani RM, Jordao ML, A double-masked, randomized clinical trial comparing latanoprost with unoprostone in patients with open-angle glaucoma or ocular hypertension. Ophthalmology 2001;108:259-63. [11158796]

37) 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;17:183-90 [17415690]

38) Traverso CE, Ropo A, Papadia M, Uusitalo H, 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 2010;26:97-104. [20148656]

39) Tsukamoto H, Mishima HK, Kitazawa Y, Araie M, Abe H, Negi A, , A comparative clinical study of latanoprost and isopropyl unoprostone in Japanese patients with primary open-angle glaucoma and ocular hypertension. J Glaucoma 2002;11:497-501. [12483094]

40) Walters TR, DuBiner HB, Carpenter SP, et al.; Bimatoprost Circadian IOP Study Group. 24-Hour IOP control with oncedaily bimatoprost, timolol gel-forming solution, or latanoprost: a 1-month, randomized, comparative clinical trial Surv Ophthalmol 2004;49:S26-S35 [NA]

41) Walters TR, DuBiner HB, Carpenter SP, Khan B, VanDenburgh AM 24-Hour IOP control with once-daily bimatoprost, timolol gel-forming solution, or latanoprost: a 1-month, randomized, comparative clinical trial. Surv Ophthalmol 2004;49 Suppl 1:S26-35 [15016559]

42) Whitson JT, Trattler WB, Matossian C, Williams J, Hollander DA, Ocular surface tolerability of prostaglandin analogs in patients with glaucoma or ocular hypertension. J Ocul Pharmacol Ther 2010;26:287-92. [20578283]

43) Whitson JT, Trattler WB, Matossian C, Williams J, Hollander DA, Ocular surface tolerability of prostaglandin analogs in patients with glaucoma or ocular hypertension. J Ocul Pharmacol Ther 2010;26:287-92. [20578283]