Assessment of the Effectiveness, Tolerability, and Safety of the Preservative-Fr...

연구 요약

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.

Clinical ophthalmology (Auckland, N.Z.) 학술지에 발표된 이 연구는 Belalcazar S, Tornero-Jimenez A, Mejia-Morales C 외 연구팀이 수행하였습니다.

이 연구는 '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.'에 대한 과학적 분석을 제공합니다.

핵심 내용

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.

일반인을 위한 해석

구체적인 실천 사항은 담당 의사 또는 약사와 상담하시기 바랍니다.

실천 사항

• 현재 복용 중인 약물이나 영양제에 대해 궁금한 점이 있다면 담당 의사 또는 약사와 상담하시기 바랍니다
• 약물이나 영양제의 용법·용량을 임의로 변경하지 마세요
• 이상 반응이 나타나면 즉시 전문가에게 문의하세요

의사/약사의 전문적 판단을 대체하지 않습니다 (PMID: 41737851)

📄 [전문 보기 (Markdown)](fulltext/41737851-assessment-of-the-effectiveness-tolerability-and-safety-of-t.md)