Triplenex (triple Fixed Combination) Use Evaluation in Patients with Glaucoma

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

March 1, 2021

Primary Completion Date

December 10, 2024

Study Completion Date

February 26, 2025

Conditions
GlaucomaQuality of Life (QOL)
Interventions
DRUG

Triple combination formula

"Individuals 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."

DRUG

Bimatoprost .03% sterile ophthalmic solution

"Individuals 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 0.2%(1 drop twice a day), Timolol Maleate 0.5% (1 drop twice a day) and Bimatoprost 0.3% (1 drop at night). At the first visit a complete ophthalmolgical exam which includes ocular surface items (conjunctival hiperemia, keratitis and tear film break up time). Questionnaires are performed (Ocular Surface Disease Index, Glaucoma Treatment Compliance Assessment Tool and National Eye Institute Visual Function Questionnaire) to assess information about ocular surface adverse effects, quality of life and treatment adherence. Glaucoma exams as retinography, perimetry, optic nerve OCT (optical coherence tomography), central corneal thickness are performed on all patients to evaluate disease's control. This procedure will be repeated at all visits: baseline and within 4, 8, 12 weeks."

Trial Locations (1)

04021001

Federal University of São Paulo, São Paulo

All Listed Sponsors
lead

Federal University of São Paulo

OTHER