Brimonidine 2mg/ml / Timolol 5mg/ml eye drops

Purpose: Standard automated perimetry (SAP) remains the gold standard functional test in glaucoma, used primarily for evaluating peripheral vision loss. Central contrast sensitivity (CCS) has emerged as a potential early functional marker of glaucomatous damage. This systematic review aimed to describe the different methods used to measure CCS in randomized controlled trials (RCT) involving glaucoma patients. Methods: We searched the MEDLINE, Embase, CINAHL, Cochrane Central Register of Controlled Trials, Epistemonikos, and ClinicalTrials.gov databases on 25 January 2023, and updated the search on 12 February 2025. Eligible studies comprised RCTs that reported CCS as an outcome in patients with glaucoma, suspected glaucoma, or ocular hypertension. No restrictions were placed on age, sex, ethnicity, geography, intervention, or publication year. Abstracts and full texts were screened independently by two reviewers. Descriptive statistics were used. No formal risk of bias assessment was performed, due to the descriptive nature of the review. Results: Of 1066 records screened, 31 studies met the eligibility criteria. The study sample size ranged from 7 to 207 (median: 23), with most studies involving primary open-angle glaucoma. Interventions were diverse, mainly involving topical medications, with timolol being the most frequent. Eleven CCS test methods were identified. Five studies did not report the method used. The CSV-1000 was the most commonly used test, being applied in 11 studies. Conclusions: CCS has been measured using a wide range of methods in glaucoma RCTs, with limited standardization. Most of the included studies were small, variably reported, and conducted over 10 years ago, suggesting a decreasing interest in CCS as an outcome measure in glaucoma RCTs. Funding: This review was funded by Oslo University Hospital and the Research Council of Norway. Registration: This review was registered on the OSF.

Abstract licence: CC BY

Abstract Introduction 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. Methods 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. Results 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. Conclusions 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. Funding Laboratorios Sophia, S.A. de C.V. (Zapopan, Jalisco, México). Trial Registration ClinicalTrials.gov identifier: NCT03257813 (registered retrospectively).

Abstract licence: CC BY 4.0