Work

Assessment of the Effectiveness, Tolerability, and Safety of the Preservative-Free Fixed Combination of Timolol, Dorzolamide, and Brimonidine Compared to Separate Therapies in Patients with Glaucoma, a Randomized Controlled Trial

Year: 2026

Type: article

Study designs: Randomized Controlled Trial, Clinical Trial

Abstract: Purpose: To assess the non-inferiority of a preservative-free fixed combination of timolol, dorzolamide, and brimonidine (TDB-FC/PF) compared to the same fixed combination with preservatives or concomitant therapy for treating patients with uncontrolled primary open-angle glaucoma (POAG). Patients and Methods: This Phase III study included 80 eyes from 43 patients randomized to receive TDB-FC/PF (preservative-free), TDB-FC (with preservatives), or TDB (triple therapy separately with preservatives) over 90 days. Follow-up visits took place at 2 and 4 weeks, and at 2 and 3 months. A mixed-effects model was used for the analysis. The primary outcome was intraocular pressure (IOP), measured at 9:00 a.m. and 11:00 a.m. Tolerability was assessed using the Ocular Comfort Index (OCI) and by evaluating conjunctival hyperemia and corneal staining. Safety assessments included best-corrected visual acuity, chemosis, visual fields, cup-to-disc ratio, central corneal thickness, and adverse event recording. Results: After three months of treatment, the mean IOP decreased by 7.7, 8.3, and 8.3 mmHg at 9:00 a.m. and by 9.3, 9.8, and 9.6 mmHg at 11:00 a.m. for TDB-FC/PF, TDB-FC, and TDB, respectively (p = 0.624 and 0.753). The TDB-FC group showed a significant increase in conjunctival hyperemia severity at 2 and 4 weeks (p = 0.044 and 0.034, respectively). No significant differences were observed among groups for OCI, ocular surface staining, or safety parameters. Conclusion: TDB-FC/PF effectively lowers IOP and is comparable to preserved fixed combinations or triple therapy in effectiveness. It is well tolerated, has a favorable safety profile, and offers the benefits of preservative-free formulations, which can enhance adherence in patients with POAG who need multiple medications. Trial Registration: ClinicalTrials.gov identifier, NCT03193333.

Source: Clinical ophthalmology

DOI: 10.2147/opth.s580973

Authors: Sandra Belalcazar, Andrea Tornero-Jimenez, Claudia Mejia-Morales, Oscar Olvera-Montaño, Patricia Muñoz-Villegas

Institutions: Laboratorios Sophia (Mexico), Mathematics Research Center

Language: English

Topic: Glaucoma and retinal disorders

Subfield: Ophthalmology

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $2,320