Preservative-free versus preserved latanoprost eye drops in patients with open-angle glaucoma or ocular hypertension

Abstract

Objective: This study compared the efficacy, safety, and pharmacokinetics of a preservative-free latanoprost formulation to an established, benzalkonium chloride (BAK) containing formulation for the treatment of open-angle glaucoma or ocular hypertension.

Methods: This was a phase II, randomized, cross-over, investigator-masked, multi-center, pilot study (NCT01494753). A total of 30 untreated adult patients (aged ≥18 years) with primary open angle glaucoma, pseudo-exfoliative glaucoma, pigmentary glaucoma, or ocular hypertension received either preservative-free or preserved latanoprost once daily in both eyes for 6 weeks, before crossing over to receive the other treatment. Efficacy (intraocular pressure [IOP] at 8 am, midday, 4 pm and 8 pm, and global efficacy assessment by investigator), safety (adverse events, ocular symptoms and global tolerance, slit lamp examination, funduscopy, visual field examination, visual acuity, and heart rate), and pharmacokinetics were assessed at Days 0, 42, and 84.

Results: Both treatments resulted in a reduction in IOP that was similar for the preservative-free and the preserved formulation at all time points. Similarly, the overall diurnal reduction was similar in both groups (6.3 mmHg [27.9% reduction] and 6.4 mmHg [28.1% reduction] for preserved and preservative-free latanoprost, respectively). There were no differences in global efficacy assessment or in the safety and tolerance of each treatment. Systemic concentrations of latanoprost were very low; AUC_0–30 and C_max were lower and t_max was longer for preservative-free latanoprost.

Conclusions: Preservative-free latanoprost showed similar efficacy at all time points compared to BAK preservative containing formulation, with no difference in tolerance, allowing progression to phase III clinical development.

Keywords:

• Eye drop
• glaucoma
• ocular hypertension
• preservative-free
• prostaglandin

Notes

Transparency

Declaration of funding

Editorial support for this study was funded by Laboratoires Théa, Clermont-Ferrand, France. No author received payment for their contribution to this article.

Declaration of financial/other relationships

F.A. has disclosed that he is a paid consultant of Laboratoires Théa. R.C. and I.S. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.

CMRO peer reviewers on this manuscript have received an honorarium from CMRO for their review work, but have no relevant financial or other relationships to disclose.

Acknowledgments

The study personnel and patients are acknowledged for their participation.

The authors would also like to thank Dr Andrew Lane (Lane Medical Writing) who provided professional medical writing assistance, funded by Laboratoires Théa, in the preparation and development of this manuscript in accordance with the European Medical Writers Association guidelines and GPP3 (Good Publication Practice) guidelines.

Notes

1 Xalatan is a registered trade name of Pfizer, New York, USA

2 Monoprost is a registered trade name of Laboratoires Théa, Clermont-Ferrand, France