Clinical Research Directory

Dorzolamide/Brimonidine/Timolol Impact on Ocular Surface, Glaucoma Progression & Chatbot Follow-up: GLAUCO-TECH

Sponsor: Tecnoquimicas

Summary

The primary objective of this study is to evaluate the ocular surface safety of an ophthalmic solution indicated for the management of glaucoma, containing the active ingredients dorzolamide, timolol, and brimonidine, in patients diagnosed with primary open-angle glaucoma. The most relevant questions to be answered by this study are: In patients with ocular hypertension or open-angle glaucoma, does treatment with the preservative-free dorzolamide-timolol-brimonidine combination improve ocular surface health? Will there be differences in treatment adherence between patients with ocular hypertension or open-angle glaucoma using a preservative-free dorzolamide-timolol-brimonidine combination versus a combination with preservatives? Will there be differences in therapeutic efficacy between patients with ocular hypertension or open-angle glaucoma when using a preservative-free dorzolamide-timolol-brimonidine combination versus a preservative-containing dorzolamide-timolol-brimonidine combination? Will there be differences in changes in biomolecular markers on the ocular surface between patients with ocular hypertension or open-angle glaucoma when using a preservative-free dorzolamide-timolol-brimonidine combination versus a preservative-containing dorzolamide-timolol-brimonidine combination? Researchers will study these differences by comparing a formulation with the dorzolamide, timolol, and brimonidine combination that uses a preservative versus another with the same combination that does not use preservatives. Preservatives are used in ophthalmic solutions to prevent bacterial contamination. New technological developments in bottles allow for solutions without the need for preservatives. Participants must: * Take their medication according to the investigator's instructions for at least 4 months * Attend follow-up appointments at the beginning, and every 2 months until 4 months have passed * Answer phone calls every 15 days * Complete the quality of life questionnaires within the timeframes defined by the investigator

Official title: GLAUCO-TECH Study: Safety & Efficacy of Preservative-free vs. Preserved Dorzolamide-Timolol-Brimonidine. Impact on the Ocular Surface, Glaucoma Progression, Tear Proteomics, and AI/Chatbot-led Patient Follow-up.

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