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Evaluation of the use of Triplenex in Glaucoma: clinical trial

Evaluation of the use of Triplenex (triple fixed combination) in patients with Glaucoma: randomized clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-95qrz8g
Enrollment
Unknown
Registered
2025-02-06
Start date
2021-03-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary open angle glaucoma

Interventions

This is a randomized controlled clinical trial with two arms in patients with glaucoma using at least three hypotensive eye drops from different classes. Experimental group: 26 glaucoma individuals wi

Sponsors

Universidade Federal de São Paulo
Lead Sponsor
Universidade Federal de São Paulo
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients over 18 years old; both genders; diagnosed with glaucoma (determined by at least 2 criteria: intraocular pressure without eye drops above 21mmHg; typical defect in perimetry; localized damage in the nerve fiber layer); using at least 3 different classes of hypotensive eye drops; informed consent form granted

Exclusion criteria

Exclusion criteria: Patients with a history of ocular surface disease; intraocular surgeries (except cataract surgery); ocular trauma; secondary glaucomas; current use of contact lenses; systemic medications that may alter the tear film; steroids; or intolerance to any of the study drugs

Design outcomes

Primary

MeasureTime frame
Evaluate the efficacy of Triplenex (fixed triple combination) compared to the same substances separated into three eye drops (Bimatoprost 0.03%, Timolol Maleate 0.5%, and Brimonidine Tartrate 0.2%);Evaluate the adverse effects of Triplenex (fixed triple combination) compared to the same substances separated into three eye drops (Bimatoprost 0.03%, Timolol Maleate 0.5%, and Brimonidine Tartrate 0.2%)

Secondary

MeasureTime frame
Evaluate the adherence of patients using the fixed combination compared to the use of the same three drugs separately;Evaluate the quality of life of patients using the fixed combination compared to the use of the same three drugs separately

Countries

Brazil

Contacts

Public ContactLilian Machado

Universidade Federal de São Paulo

lilianmachado77@gmail.com+55(11)55764848

Outcome results

None listed

Source: REBEC (via WHO ICTRP)