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

Phase 4

Active, not recruiting

Interventions: Drug: Triple combination formula
Drug: Bimatoprost .03% sterile ophthalmic solution

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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Group I: Triplenex (Triple Fixed Combination Eyedrop)	Triple combination formula	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 .
Group II: Brimonidine Tartarate 0.2%, Timolol Maleate 0.5%, Bimatoprost 0.03%	Bimatoprost .03% sterile ophthalmic solution	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.

Primary Outcome Measures

Name	Time	Method
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 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 Outcome Measures

Name	Time	Method
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 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.