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Blood-aqueous Barrier Changes After the Use of Timolol and Prostaglandin Analogues Fixed Combination in Pseudophakic Patients With POAG

Cystoid Macular Edema Clinical Trial

Official title:
Blood-aqueous Barrier Changes After the Use of Timolol and Prostaglandin Analogues Fixed Combination in Pseudophakic Patients With Primary Open Angle Glaucoma

Clinical Trial Summary

Glaucoma, a progressive optic disc neuropathy causing visual field reduction, is the second leading cause of world blindness. The treatment of glaucoma is mainly based in reducing intraocular pressure (IOP) with topical medications. Many patients required two or more medications to achieve a target IOP. Combinations of B-blockers and prostaglandin analogs (PGA) are frequently used in clinical practice because their additive effect in lowering IOP levels. The aim of this study was to investigate the effects of fixed combinations of timolol maleate and PGA on the blood-aqueous barrier and evaluate the measurement of foveal thickness in pseudophakic patients with primary open-angle glaucoma (POAG).

Clinical Trial Description

Most studies found a lower incidence of systemic and ocular adverse events with fixed combinations than with the unfixed combinations. Fixed combinations are better tolerated than their respective prostaglandin analogue. However, among the most serious side effects induced by PGA are the breaking down of the blood-aqueous barrier (BAB) and the development of cystoids macular edema (CME). Also, timolol maleate drops increase protein concentration in the human and benzalkonium chloride, eye drops preservative induces anterior chamber inflammation. This randomized, masked-observer, prospective clinical trial was approved by the Ethics Committee of the University of Campinas, and it adhered to the tenets of the Declaration Of Helsinki. Written informed consent was obtained from each patient. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01978015
Study type Interventional
Source University of Campinas, Brazil
Contact
Status Completed
Phase Phase 4
Start date October 2011
Completion date January 2013
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