Advertisement

Advances in Therapy

, Volume 30, Issue 3, pp 260–270 | Cite as

Ocular Surface Tolerability of Prostaglandin Analogs and Prostamides in Patients with Glaucoma or Ocular Hypertension

  • Andrew C. S. CrichtonEmail author
  • Steven Vold
  • Julia M. Williams
  • David A. Hollander
Open Access
Original Research

Abstract

Introduction

There has been increased attention on the potential impact of the preservative benzalkonium chloride (BAK) on the ocular surface. This study compared the ocular surface tolerability of once-daily bimatoprost 0.01% and latanoprost 0.005% (both preserved with 0.02% BAK), and travoprost 0.004% preserved with sofZia™.

Methods

A randomized, multicenter (15 sites), investigator-masked study enrolled patients with open-angle glaucoma or ocular hypertension who had received latanoprost monotherapy for at least 1 month. Patients were randomized to oncedaily bimatoprost (n = 56), travoprost (n = 53), or latanoprost (n = 55) monotherapy for 3 months. Follow-up visits were at weeks 1, 4, and 12. The primary outcome measure was physician-graded conjunctival hyperemia (scale 0 to 3) at week 12. Secondary outcomes included corneal staining (scale 0 to 3) and tear break-up time (TBUT).

Results

There were no significant differences in mean (standard deviation [SD]) outcome measures including conjunctival hyperemia (bimatoprost: 0.48 [0.52], travoprost: 0.49 [0.52], latanoprost: 0.51 [0.54]), corneal staining (bimatoprost: 0.31 [0.49], travoprost: 0.25 [0.46], latanoprost: 0.24 [0.45]), or TBUT (bimatoprost: 9.7 s [6.1], travoprost: 9.5 s [5.8], latanoprost: 9.8 s [5.0]) among subjects at latanoprost-treated baseline (P ≥ 0.664). At week 12, there were no significant differences in conjunctival hyperemia (bimatoprost: 0.42 [0.48], travoprost: 0.46 [0.44], latanoprost: 0.44 [0.57]), corneal staining (bimatoprost: 0.31 [0.45], travoprost: 0.32 [0.48], latanoprost: 0.22 [0.30]), or TBUT (bimatoprost: 9.7 s [5.7], travoprost 9.7 s [5.0], latanoprost: 9.3 s [4.0]) among the treatment groups (P ≥ 0.379). At week 1, there was a statistically significant among-group difference in mean change from baseline in hyperemia (+0.04, bimatoprost; +0.20, travoprost; 0.00, latanoprost; P = 0.018). There were no statistically significant among-group differences in mean corneal staining, mean TBUT, or change from baseline at any visit.

Conclusions

Despite preservative differences, there were no significant differences in objective clinical measures of ocular surface tolerability after 3 months of treatment with bimatoprost (with 0.02% BAK), travoprost (with sofZia), and latanoprost (with 0.02% BAK).

Keywords

Benzalkonium chloride Bimatoprost Conjunctival hyperemia Glaucoma Latanoprost Ocular hypertension Ophthalmology sofZia Travoprost 

References

  1. 1.
    Woodward DF, Krauss AH, Chen J, et al. The pharmacology of bimatoprost (Lumigan). Surv Ophthalmol. 2001;45:S337–S345.PubMedCrossRefGoogle Scholar
  2. 2.
    Woodward DF, Krauss AH, Chen J, et al. Pharmacological characterization of a novel antiglaucoma agent, Bimatoprost (AGN 192024). J Pharmacol Exp Ther. 2003;305:772–785.PubMedCrossRefGoogle Scholar
  3. 3.
    McKee HD, Gupta MS, Ahad MA, Saldaña M, Innes JR. First-choice treatment preferences for primary open-angle glaucoma in the United Kingdom. Eye (Lond). 2005;19:923–924.CrossRefGoogle Scholar
  4. 4.
    Holló G. The side effects of the prostaglandin analogues. Expert Opin Drug Saf. 2007;6:45–52.PubMedCrossRefGoogle Scholar
  5. 5.
    Cracknell KP, Grierson I. Prostaglandin analogues in the anterior eye: their pressure lowering action and side effects. Exp Eye Res. 2009;88:786–791.PubMedCrossRefGoogle Scholar
  6. 6.
    Abelson MB, Mroz M, Rosner SA, Dirks MS, Hirabayashi D. Multicenter, open-label evaluation of hyperemia associated with use of bimatoprost in adults with open-angle glaucoma or ocular hypertension. Adv Ther. 2003;20:1–13.PubMedCrossRefGoogle Scholar
  7. 7.
    Leal BC, Medeiros FA, Medeiros FW, Santo RM, Susanna R, Jr. Conjunctival hyperemia associated with bimatoprost use: a histopathologic study. Am J Ophthalmol. 2004;138:310–313.PubMedCrossRefGoogle Scholar
  8. 8.
    Novack GD, Evans R. Commercially available ocular hypotensive products: preservative concentration, stability, storage, and in-life utilization. J Glaucoma. 2001;10:483–486.PubMedCrossRefGoogle Scholar
  9. 9.
    Furrer P, Mayer JM, Gurny R. Ocular tolerance of preservatives and alternatives. Eur J Pharm Biopharm. 2002;53:263–280.PubMedCrossRefGoogle Scholar
  10. 10.
    Caraccio TR, McGuigan MA. Benzalkonium chloride. In: Dart RC, ed. Medical Toxicology, 3rd ed. New York, NY: Lippincott Williams & Williams; 2004:1255–1257.Google Scholar
  11. 11.
    Charnock C. Are multidose over-the-counter artificial tears adequately preserved? Cornea. 2006;25:432–437.PubMedCrossRefGoogle Scholar
  12. 12.
    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;26:287–292.PubMedCrossRefGoogle Scholar
  13. 13.
    Baudouin C, Labbé A, Liang H, Pauly A, Brignole-Baudouin F. Preservatives in eyedrops: the good, the bad and the ugly. Prog Retin Eye Res. 2010;29:312–334.PubMedCrossRefGoogle Scholar
  14. 14.
    Schwartz GF, Kotak S, Mardekian J, Fain JM. Incidence of new coding for dry eye and ocular infection in open-angle glaucoma and ocular hypertension patients treated with prostaglandin analogs: retrospective analysis of three medical/pharmacy claims databases. BMC Ophthalmol. 2011;11:14.PubMedCrossRefGoogle Scholar
  15. 15.
    Champeau EJ, Edelhauser HF. Effect of ophthalmic preservatives on the ocular surface: conjunctival and corneal uptake and distribution of benzalkonium chloride and chlorhexidine digluconate. In: Holly FJ, ed. The Preocular Tear Film in Health, Disease and Contact Lens Wear. Lubbock, TX: Dry Eye Institute; 1986:292–302.Google Scholar
  16. 16.
    Mishima S, Maurice DM. The oily layer of the tear film and evaporation from the corneal surface. Exp Eye Res. 1961;1:39–45.PubMedCrossRefGoogle Scholar
  17. 17.
    Himebaugh NL, Begley CG, Bradley A, Wilkinson JA. Blinking and tear break-up during four visual tasks. Optom Vis Sci. 2009;86:E106–E114.PubMedCrossRefGoogle Scholar

Copyright information

© The Author(s) 2013

Authors and Affiliations

  • Andrew C. S. Crichton
    • 1
    Email author
  • Steven Vold
    • 2
  • Julia M. Williams
    • 3
  • David A. Hollander
    • 3
  1. 1.University of CalgaryCalgaryCanada
  2. 2.Vold VisionPLLCBentonvilleUSA
  3. 3.Allergan, Inc.IrvineUSA

Personalised recommendations