NCT01978015

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: University of Campinas, Brazil · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Uveitis, Anterior
• Cystoid Macular Edema

Interventions

Type	Name	Description
DRUG	travoprost and timolol maleate fixed combination	travoprost 0.004% and timolol maleate 0,5%, 1 eye drop at 8p.m. for 6 months
DRUG	latanoprost and maleate timolol fixed combination	Latanoprost 0.005% and timolol maleate 0,5%, 1 eye drop at 8 p.m for 6 months
DRUG	bimatoprost and timolol maleate fixed combination	bimatoprost0.03% and timolol maleate 0,5%, 1 eye drop at 8 p.m for 6 months
DRUG	dextran and hypromellose	Dextran 70 and hypromellose, lubricant eye drop at 8 a.m and 8 p.m for 6 months

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-07-01
• Completion: 2013-01-01
• First posted: 2013-11-07
• Last updated: 2013-11-07

Locations

1 site across 1 country: Brazil