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

5. juli 2026 opdateret af: 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

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

140

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Kombinationsprodukt: 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.
Andre navne:
  • Biomarkører
  • OSDI
  • Educational Chatbot and Artificial Intelligence-Assisted Electronic Health Record
Andet: 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.
Kombinationsprodukt: 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.
Andre navne:
  • Biomarkører
  • OSDI
  • Educational Chatbot and Artificial Intelligence-Assisted Electronic Health Record

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in efficacy and quality of life and adherence questionnaires between two different formulations
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Tecnoquimicas

Efterforskere

  • Ledende efterforsker: Carlos Cifuentes, MD, Clinica Sigma

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. juni 2026

Primær færdiggørelse (Anslået)

10. juli 2027

Studieafslutning (Anslået)

1. september 2027

Datoer for studieregistrering

Først indsendt

10. juni 2026

Først indsendt, der opfyldte QC-kriterier

5. juli 2026

Først opslået (Faktiske)

8. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CEI-002

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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