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NCT07690397
Dorzolamide/Brimonidine/Timolol Impact on Ocular Surface, Glaucoma Progression & Chatbot Follow-up: GLAUCO-TECH
Conditions: Primary Open-Angle Glaucoma (POAG), Ocular Hypertension
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 140
Sponsor: Tecnoquimicas
Location: Clínica Sigma Cali Cali Valle del Cauca Department
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
Eligibility Criteria
Inclusion Criteria: Age 18 years or older.
* Diagnosis of primary open-angle glaucoma or ocular hypertension, confirmed by the treating ophthalmologist.
* Continuous and stable treatment with a topical fixed-dose combination of dorzolamide, timolol, and brimonidine in a preservative formulation, for a minimum of 3 months and a maximum of 12 months prior to study enrollment.
* No prior use of preservative-free formulations of dorzolamide, timolol, and brimonidine.
* Exclusive use of the fixed-dose combination of dorzolamide, timolol, and brimonidine, without other concomitant ocular hypotensive agents.
* Ability to attend all study visits and procedures.
* Signed written informed consent.
Exclusion Criteria: Patients with any of the following conditions will be excluded:
* History of glaucoma, retinal, or cataract surgery.
* History of corneal refractive surgery (LASIK, PRK, SMILE).
* Diagnosis of secondary glaucoma (neovascular, inflammatory, traumatic, or other secondary causes).
* History of previous iridotomy, iridoplasty, or trabeculoplasty procedures.
* Presence of concomitant ocular diseases that may interfere with the evaluation of the ocular surface (e.g., Sjögren's syndrome, active infectious keratitis, or severe ocular allergy).
* Decompensated systemic conditions that contraindicate the use of topical beta-blockers (uncontrolled asthma, bradycardia, second- or third-degree AV block).
* Pregnancy or breastfeeding.
* Any medical or ophthalmological condition that, in the investigator's judgment, compromises the participant's safety or the validity of the data.
Source: ClinicalTrials.gov (NCT07690397). StuddyBuddy aggregates publicly available trial information.