Clinical trial NCT06761313: Triplenex (triple Fixed Combination) Use Evaluation in Patients with Glaucoma
Official title: Triplenex (triple Fixed Combination) Use Evaluation in Patients with Glaucoma: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Glaucoma
Quality of Life (QOL)
Keywords: Glaucoma
Triplenex
Triple combination
QoL
Addherence
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this clinical trial approved by the Unifesp Etical and Research Comitte, volunteer glaucoma patients will be recruited from Unifesp Glaucoma Sector and VerMais Glaucoma Sector. They will be randomly divided em two groups,Group I is going to be treated with Triplenex (1 drop twice a day) and Grupo II with Brimonidine Tartarate (1 drop twice a day), Timolol Maleate (1 drop twice a day) and Bimatoprost (1 drop at night). At baseline visit a complete ophthalmolgical exam will be performed along with three questionnaires ("Ocular Surface Disease Index", "Glaucoma Treatment Compliance Assessment Tool" and "National Eye Institute Visual Function Questionnaire"),retinography, visual field, optic nerve OCT in all patients. This procedure will be repeated at baseline and within 4, 8, 12 weeks.
Primary purpose: TREATMENT

Brief summary: This project purpose is to evaluate the effectiveness, ocular surface quality, medication adherence and quality of life in 46 glaucoma patients in use of three separate drugs (Bimatoprost 0.3%, Timolol Maleate 0.5% and Brimonidine Tartrate 0.2%) comparing with triple combination, Triplenex. In this clinical trial approved by the Unifesp Etical and Research Comitte, volunteer glaucoma patients will be recruited from Unifesp Glaucoma Sector and VerMais Glaucoma Sector. They will be randomly divided em two groups,Group I is going to be treated with Triplenex (1 drop twice a day) and Grupo II with Brimonidine Tartarate (1 drop twice a day), Timolol Maleate (1 drop twice a day) and Bimatoprost (1 drop at night). At baseline visit a complete ophthalmolgical exam will be performed along with three questionnaires ("Ocular Surface Disease Index", "Glaucoma Treatment Compliance Assessment Tool" and "National Eye Institute Visual Function Questionnaire"),retinography, visual field, optic nerve OCT in all patients. This procedure will be repeated at baseline and within 4, 8, 12 weeks.

Detailed description: This clinical study aims to compare the use of the hypotensive eye drop Triplenex, a fixed triple combination (currently available only in Brazil, Mexico, and Chile), with the globally recognized combination of the same drugs administered separately. The combination of the eye drops Bimatoprost 0.3%, Timolol Maleate 0.5%, and Brimonidine Tartrate 0.2% in separate vials is traditionally used in patients with difficult intraocular pressure control or advanced glaucoma that requires a low target pressure for proper disease management. The fixed triple combination intends to improve patient adherence while maintaining the efficacy of intraocular pressure control and progression of glaucoma. This study arises in the context of a lack of literature comparing Triplenex to the three original drugs and the absence of data on its influence on adherence, ocular surface, and the quality of life in the daily lives of glaucoma patients.

Eligibility criteria: Inclusion Criteria:

* patients with diagnosed glaucoma
* above 18 years old
* in use of at least 3 different glaucoma eyedrops classes
* informed consent form granted

Exclusion Criteria:

* secundary glaucoma
* previous ocular surface disease
* previous intraocular surgeries (except cataract)
* previous ocular trauma
* current use of contact lenses use
* current use of steroids or systemic medications that may change ocular surface
* any study's drug intolerance

Primary outcomes:
measure: Triplenex (triple fixed combination) use evaluation in patients with Glaucoma: randomized clinical trial
timeFrame: From enrollment to the end of treatment at 6 months
measure: Triplenex (triple fixed combination) use evaluation in patients with Glaucoma: randomized clinical trial
timeFrame: From enrollment to the end of treatment at 6 months
Secondary outcomes:
measure: Triplenex (triple fixed combination) use evaluation in patients with Glaucoma: randomized clinical trial
timeFrame: From enrollment to the end of treatment at 6 months
measure: Triplenex (triple fixed combination) use evaluation in patients with Glaucoma: randomized clinical trial
timeFrame: From enrollment to the end of treatment at 6 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Federal University of São Paulo
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Carolina Gracitelli, Affiliate Professsor
role: STUDY_CHAIR
References:
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citation: Belfort R Jr, Paula JS, Lopes Silva MJ, Della Paolera M, Kim T, Chen MY, Goodkin ML. Fixed-combination Bimatoprost/Brimonidine/Timolol in Glaucoma: A Randomized, Masked, Controlled, Phase III Study Conducted in Brazil☆. Clin Ther. 2020 Feb;42(2):263-275. doi: 10.1016/j.clinthera.2019.12.008. Epub 2020 Feb 20.
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