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

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT06761313
Lead Sponsor Federal University of São Paulo
Conditions
(from sponsor)		 Glaucoma, Quality of Life (QOL)
Related terms Glaucoma
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov