A randomized clinical trial comparing three fixed combinations of bimatoprost with timolol in patients with open-angle glaucoma or ocular hypertension

Abstract

Objective

To compare the efficacy and safety of two fixed combination, preservative-free eye drops (bimatoprost 0.01% in combination with either timolol 0.1% or 0.5%) in a gel formulation, with bimatoprost 0.03%/timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

Methods

Phase II, randomized, investigator-masked, multicenter, 3-arm parallel group (Eudract No. 2017-002823-46). Eighty-six patients aged ≥18 years with OAG or OHT, with intraocular pressure (IOP) initially controlled for at least 6 months by a combination therapy of a dual prostaglandin and timolol or insufficiently controlled by first-line monotherapy were included. Patients were randomized to receive T4030a (bimatoprost 0.01%/timolol 0.1%; N = 29), T4030c (bimatoprost 0.01%/timolol 0.5%; N = 29) or bimatoprost 0.03%/timolol 0.5% (N = 28), administered once daily in the evening for 12 weeks. Primary endpoint was defined as change in IOP from day 1 to week 12 measured at 08:00 (±1 h). Further efficacy, safety and pharmacokinetic endpoints were assessed as secondary outcomes.

Results

The mean change in IOP from baseline to week 12 was −9.8 ± 2.1 mmHg for T4030a, −10.1 ± 2.5 mmHg for T4030c and −10.0 ± 2.8 mmHg for bimatoprost 0.03%/timolol 0.5%. All treatments were well tolerated with no safety issues identified in any group. In patients treated with T4030a, the systemic concentration of timolol was significantly lower after 12 weeks than in patients treated with T4030c or bimatoprost 0.03%/timolol0.5%.

Conclusions

These study results suggest that the preservative-free ophthalmic formulation of T4030a (bimatoprost 0.01%/timolol 0.1%) can be regarded as a useful tool in the therapeutic management of OAG and OHT.

Keywords:

• Glaucoma
• ocular hypertension
• bimatoprost
• timolol
• preservative-free
• pharmacokinetics

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

Ewa Mrukwa-Kominek; Marta Misiuk-Hojlo; Dr Adrienne Csutak;Ingeborg Stalmans and Gerhard Garhofer were investigators of the study and received financial compensation.

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

All authors participated in the conduct of the study and in the review and approval of the manuscript.

Acknowledgements

The authors thank Richard Allan of Laboratoires Théa for medical writing services.

Ethical approval

This study involved human participants and was approved by independent Ethics Committee(s) in each participating country.

Notes

i Ganfort (Allergan, Ireland)

ii Geltim (Laboratoires Théa, France)

iii Azopt (Novartis Pharma, Switzerland)