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The aim of this prospective crossover study was to evaluate the non-inferiority of PRO-122 (a preservative-free fixed combination) compared with 0.5% timolol + 0.2% brimonidine + 2.0% dorzolamide fixed combination (KOF) by evaluating its efficacy, tolerability and safety in subjects with controlled primary open-angle glaucoma (POAG) previously treated with KOF for at least 2 months.
In a prospective, crossover, randomized, double-masked multicenter study, patients previously treated with KOF were randomly assigned to receive either PRO-122 or KOF for 30 days. On day 31, the A sequence changed to KOF, while the B sequence received PRO-122. All patients remained in the protocol for 30 additional days for a total of 60 days. The main efficacy endpoint was maintaining the controlled intraocular pressure (IOP). The safety and tolerability of both products were assessed by the presence of adverse events (AEs), ocular findings, a questionnaire on ocular comfort and the VF-14 index.
A total of 51 patients participated. After application of PRO-122 twice a day, its efficacy was demonstrated through maintenance of the controlled IOP in patients previously controlled with KOF. The crossover between PRO-122 and KOF and vice versa, after 30 days of use, did not affect IOP control. PRO-122 was shown not to be inferior to KOF in maintaining IOP at control levels. The safety of both drugs is similar, as neither presented drug-related AEs or differences regarding safety issues. The tolerability of the two medications—evaluated by ocular findings, the questionnaire on ocular comfort and the VF-14 index—was also determined to be similar.
The controlled IOP in patients with controlled POAG treated with PRO-122 was maintained both in relation to the initial controlled IOP of the study and when compared with KOF in the B sequence. Finally, the treatment with PRO-122 demonstrated similar safety and tolerability to KOF.
Laboratorios Sophia, S.A. de C.V. (Zapopan, Jalisco, México).
ClinicalTrials.gov identifier: NCT03257813 (registered retrospectively).
Mitchell P, et al. Prevalence of open-angle glaucoma in Australia. J Ophthalmol. 1996;103:1661–9.
Tielsch J, et al. Racial variations in the prevalence of primary open-angle glaucoma. JAMA J Am Med Assoc. 1991;266:369–74. CrossRef
European Glaucoma Society. Terminology and Guidelines for Glaucoma, 4th Edition—Chapter 3. Italy: Publicomm. pp 1–72; 2014.
Higginbotham EJ. Considerations in glaucoma therapy: fixed combinations versus their component medications. Clin Ophthalmol. 2009;4:1–9. CrossRef
Anderson RD, Paterlla VM. Automated static perimetry. 2nd ed. St Louis: Mosby; 1999.
Budengeri P, Cheng JW, Cai JP, Wei RL. Efficacy and tolerability of fixed combination of brimonide 0.2% + timolol 0.5% compared with fixed combination of dorzolamide 2% + timolol 0.5% in the treatment of patients with elevated intraocular pressure: a meta-analysis of randomized controlled trials. J Ocul Pharmacol Ther. 2013;29:474–9. CrossRefPubMed
García-López A, Paczka JA, Jiménez-Román J, Hartleben C. Efficacy and tolerability of fixed-combination bimatoprost-timolol versus fixed-combination dorzolamide-brimonide-timolol in patients with primary open-angle glaucoma or ocular hypertension: a multicenter, prospective, crossover study. BMC Ophthalmol. 2014;14:161. CrossRefPubMedPubMedCentral
Baiza-Durán L, et al. The efficacy and safety of two fixed combinations: timolol-dorzolamide-brimonide versus timolol-dorzolamide. A prospective, randomized, double-masked, multi-center, 6-month clinical trial. Ann Ophthalmol (Skokie). 2009;41:174–8.
Jaenen N, et al. Ocular symptoms and signs with preserved and preservative-free glaucoma medications. Eur J Ophthal. 2007;17:341–9. CrossRef
- A Phase III Randomized Clinical Trial of a 0.5% Timolol + 0.2% Brimonidine + 2.0% Dorzolamide Fixed Combination, Preservative-Free Ophthalmic Solution vs. 0.5% Timolol + 0.2% Brimonidine + 2.0% Dorzolamide Fixed Combination in Patients with Controlled Primary Open-Angle Glaucoma
José A. Paczka
- Springer Healthcare
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