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

Last updated: December 31, 2024
Sponsor: Federal University of São Paulo
Overall Status: Active - Not Recruiting

Phase

4

Condition

Glaucoma

Treatment

Triple combination formula

Bimatoprost .03% sterile ophthalmic solution

Clinical Study ID

NCT06761313
4.261.282
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • patients with diagnosed glaucoma

  • above 18 years old

  • in use of at least 3 different glaucoma eyedrops classes

  • informed consent form granted

Exclusion

Exclusion Criteria:

  • secundary glaucoma

  • previous ocular surface disease

  • previous intraocular surgeries (except cataract)

  • previous ocular trauma

  • current use of contact lenses use

  • current use of steroids or systemic medications that may change ocular surface

  • any study's drug intolerance

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Triple combination formula
Phase: 4
Study Start date:
March 01, 2021
Estimated Completion Date:
February 26, 2025

Study Description

This clinical study aims to compare the use of the hypotensive eye drop Triplenex, a fixed triple combination (currently available only in Brazil, Mexico, and Chile), with the globally recognized combination of the same drugs administered separately. The combination of the eye drops Bimatoprost 0.3%, Timolol Maleate 0.5%, and Brimonidine Tartrate 0.2% in separate vials is traditionally used in patients with difficult intraocular pressure control or advanced glaucoma that requires a low target pressure for proper disease management. The fixed triple combination intends to improve patient adherence while maintaining the efficacy of intraocular pressure control and progression of glaucoma. This study arises in the context of a lack of literature comparing Triplenex to the three original drugs and the absence of data on its influence on adherence, ocular surface, and the quality of life in the daily lives of glaucoma patients.

Connect with a study center

  • Federal University of São Paulo

    São Paulo, SP 04021001
    Brazil

    Site Not Available

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