ArticleClinical ophthalmology (Auckland, N.Z.)2026
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.
Article in Clinical ophthalmology (Auckland, N.Z.), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03193333 (A Non-inferiority in the Intraocular Pressure Decrease of the Preservative-free Ophthalmic Solution PRO-122 Versus Concomitant Therapy in Subjects With Uncontrolled Primary Open-angle Glaucoma), which is not on this map. Not yet cited in PubMed.
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A Non-inferiority in the Intraocular Pressure Decrease of the Preservative-free Ophthalmic Solution PRO-122 Versus Concomitant Therapy in Subjects With Uncontrolled Primary Open-angle Glaucoma
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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.
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