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

NCT07690397 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-07-08

No results posted yet for this study

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

Interventions

COMBINATION_PRODUCT

Preservative-free dorzolamide-timolol-brimonidine combination

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.

COMBINATION_PRODUCT

Preservative dorzolamide-timolol-brimonidine combination

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.

Sponsors & Collaborators

  • Tecnoquimicas

    lead INDUSTRY

Principal Investigators

  • Carlos Cifuentes, MD · Clinica Sigma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-10
Primary Completion
2027-07-10
Completion
2027-09-01

Countries

  • Colombia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07690397 on ClinicalTrials.gov