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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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Federal University of Sao Paulo
Coordinator of this site? Confirm its status
São PauloBrazilUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.