NCT06761313Active, not recruitingPhase 4
Triplenex (triple Fixed Combination) Use Evaluation in Patients with Glaucoma
Triplenex (triple Fixed Combination) Use Evaluation in Patients with Glaucoma: Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 7 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 13 Dec 2024
- Start date
- 1 Mar 2021
- Primary completion date
- 10 Dec 2024
- Lead sponsor
- Federal University of São Paulo
- Diseases
- Glaucoma
- NCT number
- NCT06761313
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 40
- From 1 Mar 2021 to the primary completion date, 10 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous ocular surface disease
- previous intraocular surgeries (except cataract)
- previous ocular trauma
- current use of steroids or systemic medications that may change ocular surface
- any study's drug intolerance
Other
- secundary glaucoma
- current use of contact lenses use
Who the study is looking for
- patients with diagnosed glaucoma
- above 18 years old
- in use of at least 3 different glaucoma eyedrops classes
- informed consent form granted
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Federal University of Sao Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.