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

A prospective, randomized, comparative, single-blind (masked evaluator) clinical trial will evaluate the preservative-free fixed-dose combination of dorzolamide, timolol, and brimonidine versus the same combination with preservatives in patients diagnosed with primary open-angle glaucoma or ocular hypertension treated in Cali, Colombia.

Adult patients with a clinical indication for topical triple hypotensive therapy, currently receiving treatment with the preservative formulation or in the process of initiating or changing treatment, will be included. Participants will be assigned to one of the two treatment groups and will be followed longitudinally under real-world clinical practice conditions, with standardized measurements.

The primary objective of the study is to compare the impact of both formulations on ocular surface health, integrating objective and subjective measures of dry eye. Secondary objectives include evaluating intraocular pressure control, ocular and systemic safety and tolerability, treatment adherence, vision-related quality of life, and signs of structural and functional glaucomatous progression. In addition, the study incorporates two substudies. The technology substudy will evaluate the effect of an educational chatbot and reminders on patient adherence, disease knowledge, and self-efficacy. The molecular substudy will explore the proteomic profile of the tear film and its variation in response to treatment, in order to identify molecular markers associated with tolerability, ocular surface inflammation, and clinical response.

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.