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

5 juillet 2026 mis à jour par: Tecnoquimicas

GLAUCO-TECH Study: Safety & Efficacy of Preservative-free vs. Preserved Dorzolamide-Timolol-Brimonidine. Impact on the Ocular Surface, Glaucoma Progression, Tear Proteomics, and AI/Chatbot-led Patient Follow-up.

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

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

140

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Colombie
    • Valle del Cauca Department
      • Cali, Valle del Cauca Department, Colombie, 760044
        • Clínica Sigma Cali

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Preservative-free dorzolamide-timolol-brimonidine combination
Participants will receive treatment with a combination of brimonidine, timolol, and dorzolamide, one drop every 12 hours for four months.
Produit combiné: 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.
Autres noms:
  • Biomarqueurs
  • OSDI
  • Educational Chatbot and Artificial Intelligence-Assisted Electronic Health Record
Autre: Preservative dorzolamide-timolol-brimonidine combination
Participants will receive treatment with a combination of brimonidine, timolol, and dorzolamide, one drop every 12 hours for four months.
Produit combiné: 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.
Autres noms:
  • Biomarqueurs
  • OSDI
  • Educational Chatbot and Artificial Intelligence-Assisted Electronic Health Record

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Changes in efficacy and quality of life and adherence questionnaires between two different formulations
Délai: From enrollment to the end of treatment at 16 weeks
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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Tecnoquimicas

Les enquêteurs

  • Chercheur principal: Carlos Cifuentes, MD, Clinica Sigma

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

10 juin 2026

Achèvement primaire (Estimé)

10 juillet 2027

Achèvement de l'étude (Estimé)

1 septembre 2027

Dates d'inscription aux études

Première soumission

10 juin 2026

Première soumission répondant aux critères de contrôle qualité

5 juillet 2026

Première publication (Réel)

8 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

8 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CEI-002

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

The information obtained in the study will be at the research center and the analysis will be carried out exclusively by the principal investigator and staff in charge at the Sigma Clinic.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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