Efficacy and safety of travoprost 0.004%/timolol 0.5% fixed combination as transition therapy in patients previously on prostaglandin analog monotherapy

Abstract

Purpose

To assess the safety and efficacy of transitioning patients whose intraocular pressure (IOP) had been insufficiently controlled on prostaglandin analog (PGA) monotherapy to treatment with travoprost 0.004%/timolol 0.5% fixed combination with benzalkonium chloride (TTFC).

Methods

This prospective, multicenter, open-label, historical controlled, single-arm study transitioned patients who had primary open-angle glaucoma, pigment dispersion glaucoma, or ocular hypertension and who required further IOP reduction from PGA monotherapy to once-daily treatment with TTFC for 12 weeks. IOP and safety (adverse events, corrected distance visual acuity, and slit-lamp biomicroscopy) were assessed at baseline, week 4, and week 12. A solicited ocular symptom survey was administered at baseline and at week 12. Patients and investigators reported their medication preference at week 12.

Results

Of 65 patients enrolled, 43 had received prior travoprost therapy and 22 had received prior nontravoprost therapy (n = 18, bimatoprost; n = 4, latanoprost). In the total population, mean IOP was significantly reduced from baseline (P = 0.000009), showing a 16.8% reduction after 12 weeks of TTFC therapy. In the study subgroups, mean IOP was significantly reduced from baseline to week 12 (P = 0.0001) in the prior travoprost cohort (19.0% reduction) and in the prior nontravoprost cohort (13.1% reduction). Seven mild, ocular, treatment-related adverse events were reported. Of the ten ocular symptom questions, eight had numerically lower percentages with TTFC compared with prior PGA monotherapy and two had numerically higher percentages with TTFC (dry eye symptoms and ocular stinging/burning). At week 12, TTFC was preferred over prior therapy for 84.2% of patients (48 of 57) by the patients themselves, and for 94.7% of patients (54 of 57) by their physicians.

Conclusion

When TTFC replaced PGA monotherapy in patients whose IOP had been uncontrolled, the outcome was a significant reduction in IOP and an acceptable safety and tolerability profile. Most patients and investigators preferred TTFC to prior PGA monotherapy.

Keywords:

• fixed combination
• glaucoma
• intraocular pressure
• prostaglandin analog
• timolol
• travoprost

Acknowledgments

Jennifer Klem, PhD provided medical writing support, which was funded by Alcon Laboratories, Inc. The authors acknowledge Dr Guilherme Guedes, who assisted in study-related operations at Dr Moreira’s site, for critical review of the manuscript. The authors also acknowledge the following coinvestigators for their participation in the trial: Dra Alana Mendonça de Santana and Dra Milena Gavros (for Dr Costa), Dra Sueli Lima Teixeira and Dr. Marcelo Shindy Iwamoto (for Dr Moreira), Dr Diego Tebaldi de Queiróz Barbosa, Dra Sheila Cristina Caniçali and Dra Adriana Chaves de Oliveira (for Dr Paolera), and Dr Mitsuo Hashimoto and Dr Alvio Isao Shiguematsu (for Dra. Silva).

Disclosure

The authors report no conflicts of interest in this work.