Active — Not RecruitingPhase 4

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

Colombia140 participantsStarted 2026-06-10

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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,…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in efficacy and quality of life and adherence questionnaires between two different formulations

Timeframe: From enrollment to the end of treatment at 16 weeks

Trial details

NCT IDNCT07690397

SponsorTecnoquimicas

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-07-10

View on ClinicalTrials.gov More Primary Open-Angle Glaucoma (POAG) trials