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GlaucomaPhase 4NCT06761313

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

A Phase 4 study testing Triple combination formula and Bimatoprost .03% sterile ophthalmic solution in people with Glaucoma and Quality of Life (QOL), run by Federal University of São Paulo at 1 site in Brazil.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glaucoma, Quality of Life (QOL)
What is being tested?
Triple combination formula and Bimatoprost .03% sterile ophthalmic solution
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteBrazil
Study dates
1 Mar 2021to 26 Feb 2025
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients with diagnosed glaucoma
  • above 18 years old
  • in use of at least 3 different glaucoma eyedrops classes
  • informed consent form granted

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Federal University of São Paulo

    São Paulo, São Paulo, 04021001

Other trials in Brazil

About this study

Official title: 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.

Read the 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.

Being tested
Triple combination formula, Bimatoprost .03% sterile ophthalmic solution
Keywords
Glaucoma, Triplenex, Triple combination, QoL, Addherence
Medical subject headings
Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Triple combination formulaDrug

    Also called Maleate Timolol 0.5%, Brimonidine Tartarate 0.2%, Bimatoprost 0.03%

    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.

  • Bimatoprost .03% sterile ophthalmic solutionDrug

    Also called Timolol Maleate 0.5%, Brimonidine Tartarate 0.2%, Bimatoprost 0.03%

    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.

Study groups in NCT06761313
Study groupRoleWhat they receive
Group I: Triplenex (Triple Fixed Combination Eyedrop)ExperimentalAfter 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 .
Receives: Drug: Triple combination formula
Group II: Brimonidine Tartarate 0.2%, Timolol Maleate 0.5%, Bimatoprost 0.03%OtherAfter 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.
Receives: Drug: Bimatoprost .03% sterile ophthalmic solution

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: From enrollment to the end of treatment at 6 months

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

    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.

    Measured: From enrollment to the end of treatment at 6 months

Secondary outcomes (2)

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

    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.

    Measured: From enrollment to the end of treatment at 6 months

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

    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.

    Measured: From enrollment to the end of treatment at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2025
  2. Study start1 Mar 2021
  3. Primary completion10 Dec 2024
  4. Study completion26 Feb 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06761313
Sponsor's protocol ID
4.261.282
Status last verified
Dec 2024
First submitted
13 Dec 2024
Last updated
7 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data sheet that does not identify the patient, and also the statistic analyses.

Publications

  • The definition and classification of dry eye disease: report of the Definition and Classification Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf. 2007 Apr;5(2):75-92. doi: 10.1016/s1542-0124(12)70081-2.

    PubMed 17508116

  • Goldberg I, Clement CI, Chiang TH, Walt JG, Lee LJ, Graham S, Healey PR. Assessing quality of life in patients with glaucoma using the Glaucoma Quality of Life-15 (GQL-15) questionnaire. J Glaucoma. 2009 Jan;18(1):6-12. doi: 10.1097/IJG.0b013e3181752c83.

    PubMed 19142128

  • Baffa Ldo P, Ricardo JR, Dias AC, Modulo CM, Braz AM, Paula JS, Rodrigues Mde L, Rocha EM. Tear film and ocular surface alterations in chronic users of antiglaucoma medications. Arq Bras Oftalmol. 2008 Jan-Feb;71(1):18-21. doi: 10.1590/s0004-27492008000100004.

    PubMed 18408831

  • Skalicky SE, Goldberg I, McCluskey P. Ocular surface disease and quality of life in patients with glaucoma. Am J Ophthalmol. 2012 Jan;153(1):1-9.e2. doi: 10.1016/j.ajo.2011.05.033. Epub 2011 Aug 26.

    PubMed 21872203

  • Fechtner RD, Godfrey DG, Budenz D, Stewart JA, Stewart WC, Jasek MC. Prevalence of ocular surface complaints in patients with glaucoma using topical intraocular pressure-lowering medications. Cornea. 2010 Jun;29(6):618-21. doi: 10.1097/ICO.0b013e3181c325b2.

    PubMed 20386433

  • Mangione CM, Lee PP, Gutierrez PR, Spritzer K, Berry S, Hays RD; National Eye Institute Visual Function Questionnaire Field Test Investigators. Development of the 25-item National Eye Institute Visual Function Questionnaire. Arch Ophthalmol. 2001 Jul;119(7):1050-8. doi: 10.1001/archopht.119.7.1050.

    PubMed 11448327

  • Newman-Casey PA, Robin AL, Blachley T, Farris K, Heisler M, Resnicow K, Lee PP. The Most Common Barriers to Glaucoma Medication Adherence: A Cross-Sectional Survey. Ophthalmology. 2015 Jul;122(7):1308-16. doi: 10.1016/j.ophtha.2015.03.026. Epub 2015 Apr 24.

    PubMed 25912144

  • Olthoff CM, Schouten JS, van de Borne BW, Webers CA. Noncompliance with ocular hypotensive treatment in patients with glaucoma or ocular hypertension an evidence-based review. Ophthalmology. 2005 Jun;112(6):953-61. doi: 10.1016/j.ophtha.2004.12.035.

    PubMed 15885795

  • Mansberger SL, Sheppler CR, McClure TM, Vanalstine CL, Swanson IL, Stoumbos Z, Lambert WE. Psychometrics of a new questionnaire to assess glaucoma adherence: the Glaucoma Treatment Compliance Assessment Tool (an American Ophthalmological Society thesis). Trans Am Ophthalmol Soc. 2013 Sep;111:1-16.

    PubMed 24072942

  • Belfort R Jr, Paula JS, Lopes Silva MJ, Della Paolera M, Kim T, Chen MY, Goodkin ML. Fixed-combination Bimatoprost/Brimonidine/Timolol in Glaucoma: A Randomized, Masked, Controlled, Phase III Study Conducted in Brazil☆. Clin Ther. 2020 Feb;42(2):263-275. doi: 10.1016/j.clinthera.2019.12.008. Epub 2020 Feb 20.

    PubMed 32089329

  • Hartleben C, Parra JC, Batoosingh A, Bernstein P, Goodkin M. A Masked, Randomized, Phase 3 Comparison of Triple Fixed-Combination Bimatoprost/Brimonidine/Timolol versus Fixed-Combination Brimonidine/Timolol for Lowering Intraocular Pressure. J Ophthalmol. 2017;2017:4586763. doi: 10.1155/2017/4586763. Epub 2017 Sep 19.

    PubMed 29057117

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Triple combination formula and Bimatoprost .03% sterile ophthalmic solution in people with Glaucoma and Quality of Life (QOL), run by Federal University of São Paulo at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06761313, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.

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