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

December 31, 2024 updated by: Lilian França Machado, Federal University of São Paulo

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 04021001
        • Federal University of São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I: Triplenex (Triple Fixed Combination Eyedrop)
After the visit during which their previous hypotensive eye drops are suspended, thus determining the baseline intraocular pressure and the ocular surface at this moment, the patients will be randomized. The experimental group (Group I) is going to be treated with Triplenex (a combination of the three drugs included in the control group), patients will be instructed to use 1 drop twice a day .
Drug: Triple combination formula
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%
Other: Group II: Brimonidine Tartarate 0.2%, Timolol Maleate 0.5%, Bimatoprost 0.03%
After the visit during which their previous hypotensive eye drops are suspended, thus determining the baseline intraocular pressure and the ocular surface at this moment, the patients will be randomized. The control group (Group II) is going to be treated with a combination of three separated eyedrops: Brimonidine Tartarate 0.2%,Timolol Maleate 0.5%, Bimatoprost 0.03%. The dosage for the eye drops Brimonidine Tartarate and Timolol Maleate will be twice a day. The drug Bimatoprost is advised to be instilled once at night. The use of the combination of the three separate drugs is instructed with a time interval of at least 10 minutes between each class of eye drop.
Drug: Bimatoprost .03% sterile ophthalmic solution
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%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of treatment at 6 months
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.
From enrollment to the end of treatment at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of treatment at 6 months
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.
From enrollment to the end of treatment at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Investigators

  • Study Chair: Carolina Gracitelli, Affiliate Professsor, Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

December 10, 2024

Study Completion (Estimated)

February 26, 2025

Study Registration Dates

First Submitted

December 13, 2024

First Submitted That Met QC Criteria

December 31, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 31, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4.261.282

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data sheet that does not identify the patient, and also the statistic analyses.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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