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Active, Not Recruiting

NCT Number: NCT06761313

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension Quality of Life (QOL)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Federal University of São Paulo

São Paulo, 04021001, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

Treatment and study plan

Triple combination formula

Drug

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.

Other names: Maleate Timolol 0.5%, Brimonidine Tartarate 0.2%, Bimatoprost 0.03%

Bimatoprost .03% sterile ophthalmic solution

Drug

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.

Other names: Timolol Maleate 0.5%, Brimonidine Tartarate 0.2%, Bimatoprost 0.03%

Primary outcomes

  1. Triplenex (triple fixed combination) use evaluation in patients with Glaucoma: randomized clinical trial

    Time frame: From enrollment to the end of treatment at 6 months

    Compare the efficacy of Triplenex (fixed triple combination) to the same substances separated into three eye drops (Bimatoprost 0.03%, Timolol Maleate 0.5%, and Brimonidine Tartrate 0.2%). The comparison of efficacy between the groups will be evaluated based on the reduction of intraocular pressure and control of glaucoma progression.

  2. Triplenex (triple fixed combination) use evaluation in patients with Glaucoma: randomized clinical trial

    Time frame: From enrollment to the end of treatment at 6 months

    Compare the adverse effects of Triplenex (fixed triple combination) to the same substances separated into three eye drops (Bimatoprost 0.03%, Timolol Maleate 0.5%, and Brimonidine Tartrate 0.2%). The side effects will be mesured by the following assessments: ocular surface assessment (conjunctival hyperemia, tear film break-up time, keratitis) and (Ocular Surface Disease Index) questionnaire. Conjunctival hyperemia and keratitis are measured on a 5-level scale, with the last level being the worst classification. Tear film break-up time is measured in time from 0 to 10 seconds, the longer the tear film takes to break the better the result.

Secondary outcomes

  1. Triplenex (triple fixed combination) use evaluation in patients with Glaucoma: randomized clinical trial

    Time frame: From enrollment to the end of treatment at 6 months

    Compare the adherence to the treatment of glaucoma patients using the fixed combination to the use of the same three drugs separately. A compliance questionnaire (Glaucoma Treatment Compliance Assessment Tool) score will be used in comparison between groups.

  2. Triplenex (triple fixed combination) use evaluation in patients with Glaucoma: randomized clinical trial

    Time frame: From enrollment to the end of treatment at 6 months

    Compare the quality of life of patients using the triple fixed combination to the use of the same three drugs separately. A quality of life questionnaire (Visual Function Questionnaire-25) will be performed every visit generating a score that will be used in the comparison between groups, in this scale a higher score means better quality of life.

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

Triplenex (triple Fixed Combination) Use Evaluation in Patients with Glaucoma: Randomized Clinical Trial

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Jan 7, 2025
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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