Glaucoma, Quality of Life (QOL)
Conditions
Keywords
Glaucoma, Triplenex, Triple combination, QoL, Addherence
Brief 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.
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.
Interventions
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.
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.
Sponsors
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Triplenex (triple fixed combination) use evaluation in patients with Glaucoma: randomized clinical trial | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Triplenex (triple fixed combination) use evaluation in patients with Glaucoma: randomized clinical trial | 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. |
Countries
Brazil
Outcome results
None listed