Dorzolamide/Brimonidine/Timolol Impact on Ocular Surface, Glaucoma Progression & Chatbot Follow-up: GLAUCO-TECH (GLAUCO-TECH)
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
A tanulmány áttekintése
Állapot
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- 4. fázis
Kapcsolatok és helyek
Tanulmányi helyek
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Valle del Cauca Department
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Cali, Valle del Cauca Department, Colombia, 760044
- Clínica Sigma Cali
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Leírás
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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Kettős
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Aktív összehasonlító: 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.
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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.
Más nevek:
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Egyéb: 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.
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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.
Más nevek:
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Changes in efficacy and quality of life and adherence questionnaires between two different formulations
Időkeret: From enrollment to the end of treatment at 16 weeks
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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?
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From enrollment to the end of treatment at 16 weeks
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Együttműködők és nyomozók
Szponzor
Nyomozók
- Kutatásvezető: Carlos Cifuentes, MD, Clinica Sigma
Publikációk és hasznos linkek
Általános kiadványok
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- Bachhuber F, Huss A, Senel M, Tumani H. Diagnostic biomarkers in tear fluid: from sampling to preanalytical processing. Sci Rep. 2021 May 12;11(1):10064. doi: 10.1038/s41598-021-89514-8.
- Ngo GH, Chadha M, Sun YJ, Yu G, Lee SH, Yeh TC, Almeida DRP, Bassuk AG, Mruthyunjaya P, Dufour A, Mahajan VB. Protocol to extract tear fluid for proteomics using Schirmer strips. STAR Protoc. 2025 Dec 19;6(4):104146. doi: 10.1016/j.xpro.2025.104146. Epub 2025 Oct 16.
- Stapleton F, Argueso P, Asbell P, Azar D, Bosworth C, Chen W, Ciolino JB, Craig JP, Gallar J, Galor A, Gomes JAP, Jalbert I, Jie Y, Jones L, Konomi K, Liu Y, Merayo-Lloves J, Oliveira FR, Perez VL, Rocha EM, Sullivan BD, Sullivan DA, Vehof J, Vitale S, Willcox M, Wolffsohn JS, Dogru M. TFOS DEWS III: Digest. Am J Ophthalmol. 2025 Nov;279:451-553. doi: 10.1016/j.ajo.2025.05.040. Epub 2025 Jun 4.
- Wolffsohn JS, Benitez-Del-Castillo JM, Loya-Garcia D, Inomata T, Iyer G, Liang L, Pult H, Sabater AL, Starr CE, Vehof J, Wang MTM, Chen W, Craig JP, Dogru M, Perez VL, Stapleton F, Sullivan DA, Jones L; + TFOS collaborator group. TFOS DEWS III: Diagnostic Methodology. Am J Ophthalmol. 2025 Nov;279:387-450. doi: 10.1016/j.ajo.2025.05.033. Epub 2025 May 30.
- Benitez-Del-Castillo JM, Burgos-Blasco B. Prevalence of dry eye disease in Spain: A population-based survey (PrevEOS). Ocul Surf. 2025 Apr;36:126-133. doi: 10.1016/j.jtos.2025.01.006. Epub 2025 Jan 17.
- Martin R, Emo Research Group. Comparison of the Ocular Surface Disease Index and the Symptom Assessment in Dry Eye Questionnaires for Dry Eye Symptom Assessment. Life (Basel). 2023 Sep 21;13(9):1941. doi: 10.3390/life13091941.
- Nattinen J, Aapola U, Nukareddy P, Uusitalo H. Clinical Tear Fluid Proteomics-A Novel Tool in Glaucoma Research. Int J Mol Sci. 2022 Jul 23;23(15):8136. doi: 10.3390/ijms23158136.
- Korenfeld M, Nichols KK, Goldberg D, Evans D, Sall K, Foulks G, Coultas S, Brazzell K. Safety of KPI-121 Ophthalmic Suspension 0.25% in Patients With Dry Eye Disease: A Pooled Analysis of 4 Multicenter, Randomized, Vehicle-Controlled Studies. Cornea. 2021 May 1;40(5):564-570. doi: 10.1097/ICO.0000000000002452.
- Brinkman D, McSwiney T, James M. Comparing the tolerability of preservative-free tafluprost versus preserved latanoprost in the management of glaucoma and ocular hypertension - an observer blinded active-control trial. Ir J Med Sci. 2024 Oct;193(5):2589-2595. doi: 10.1007/s11845-024-03704-7. Epub 2024 May 15.
- Tapply I, Broadway DC. Improving Adherence to Topical Medication in Patients with Glaucoma. Patient Prefer Adherence. 2021 Jul 2;15:1477-1489. doi: 10.2147/PPA.S264926. eCollection 2021.
- Fea AM, Vallino V, Cossu M, Marica V, Novarese C, Reibaldi M, Petrillo F. Drug Delivery Systems for Glaucoma: A Narrative Review. Pharmaceuticals (Basel). 2024 Sep 2;17(9):1163. doi: 10.3390/ph17091163.
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- Muz OE, Dagdelen K, Pirdal T, Guler M. Comparison of BAK-preserved latanoprost and polyquad-preserved travoprost on ocular surface parameters in patients with glaucoma and ocular hypertension. Int Ophthalmol. 2021 Nov;41(11):3825-3835. doi: 10.1007/s10792-021-01947-2. Epub 2021 Jul 14.
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- Lopes NLV, Gracitelli CPB, Chalita MR, de Faria NVL. Ocular Surface Evaluation After the Substitution of Benzalkonium Chloride Preserved Prostaglandin Eye Drops by a Preservative-free Prostaglandin Analogue. Med Hypothesis Discov Innov Ophthalmol. 2019 Spring;8(1):52-56.
- Siesky B, Harris A, Belamkar A, Zukerman R, Horn A, Verticchio Vercellin A, Mendoza KA, Sidoti PA, Oddone F. Glaucoma Treatment Outcomes in Open Angle Glaucoma Patients of African Descent. J Glaucoma. 2022 Jul 1;31(7):479-487. doi: 10.1097/IJG.0000000000002027. Epub 2022 Mar 29.
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- Labbe A, Terry O, Brasnu E, Van Went C, Baudouin C. Tear film osmolarity in patients treated for glaucoma or ocular hypertension. Cornea. 2012 Sep;31(9):994-9. doi: 10.1097/ICO.0b013e31823f8cb6.
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Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- CEI-002
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
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