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

NCT07690397 | Active Not Recruiting Phase 4

• 1 other identifier: CEI-002
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Primary Open-Angle Glaucoma (POAG); Ocular Hypertension

Keywords

GLAUCO-TECH, glaucoma therapy, molecular evaluation

Outcome Measures

Primary Outcomes (1)

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

  Are there significant differences in ocular surface health, adherence, quality of life, or clinical effectiveness between patients treated with preservative-free Dorzolamide-Timolol-Brimonidine and those receiving preservative-containing Dorzolamide-Timolol-Brimonidine?

  From enrollment to the end of treatment at 16 weeks

Study Arms (2)

Preservative-free dorzolamide-timolol-brimonidine combination

ACTIVE COMPARATOR

Participants will receive treatment with a combination of brimonidine, timolol, and dorzolamide, one drop every 12 hours for four months.

Combination Product: Preservative dorzolamide-timolol-brimonidine combination

Preservative dorzolamide-timolol-brimonidine combination

OTHER

Participants will receive treatment with a combination of brimonidine, timolol, and dorzolamide, one drop every 12 hours for four months.

Combination Product: Preservative-free dorzolamide-timolol-brimonidine combination

Interventions

Preservative-free dorzolamide-timolol-brimonidine combination COMBINATION_PRODUCT

At the start of the study, participants will complete quality-of-life questionnaires and undergo clinical follow-up tests. During the study, they will be randomly assigned to interact with a chatbot during the follow-up phase to compare the impact on treatment adherence. Studies using ocular surface biomarkers will be conducted before and after the assigned treatment.

Also known as: Biomarkers, OSDI, Educational Chatbot and Artificial Intelligence-Assisted Electronic Health Record

Preservative dorzolamide-timolol-brimonidine combination

Preservative dorzolamide-timolol-brimonidine combination COMBINATION_PRODUCT

At the start of the study, participants will complete quality-of-life questionnaires and undergo clinical follow-up tests. During the study, they will be randomly assigned to interact with a chatbot during the follow-up phase to compare the impact on treatment adherence. Studies using ocular surface biomarkers will be conducted before and after the assigned treatment.

Also known as: Biomarkers, OSDI, Educational Chatbot and Artificial Intelligence-Assisted Electronic Health Record

Preservative-free dorzolamide-timolol-brimonidine combination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tecnoquimicas: lead

Study Sites (1)

Clínica Sigma Cali

Cali, Valle del Cauca Department, 760044, Colombia

Location

Related Publications (26)

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MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Biomarkers

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Biological Factors

Study Officials

• Carlos Cifuentes, MD

  Clinica Sigma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The evaluator will be blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: July 8, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): July 10, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 8, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)