Clinical 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.
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Belalcazar Sandra, Tornero-Jimenez Andrea, Mejia-Morales Claudia, Olvera-Montaño Oscar, Muñoz-Villegas Patricia
Аннотация
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.
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.