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

NCT ID: NCT01978015

Last Updated: 2013-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-01-31

Brief Summary

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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

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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

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Uveitis, Anterior Cystoid Macular Edema

Keywords

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primary open angle glaucoma timolol prostaglandin analogues

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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latanoprost and timolol maleate fixed combination

Latanoprost 0.005% and timolol maleate 0,5% fixed combination was dropped once daily at 8 p.m. for 6 months

Group Type EXPERIMENTAL

latanoprost and maleate timolol fixed combination

Intervention Type DRUG

Latanoprost 0.005% and timolol maleate 0,5%, 1 eye drop at 8 p.m for 6 months

bimatoprost and timolol maleate fixed combination

bimatoprost 0.03% and timolol maleate 0,5% fixed combination was dropped once daily at 8 p.m. for 6 months

Group Type EXPERIMENTAL

bimatoprost and timolol maleate fixed combination

Intervention Type DRUG

bimatoprost0.03% and timolol maleate 0,5%, 1 eye drop at 8 p.m for 6 months

dextran and hypromellose

A control group of patients with POAG and pseudophakic after trabeculectomy without medication. These patients received a lubricant drop twice daily at 8 a.m. and 8 p.m. for 6 months

Group Type PLACEBO_COMPARATOR

dextran and hypromellose

Intervention Type DRUG

Dextran 70 and hypromellose, lubricant eye drop at 8 a.m and 8 p.m for 6 months

travoprost and timolol maleate fixed combination

Travoprost 0.004% and timolol maleate 0,5% fixed combination was dropped once daily at 8 p.m. for 6 months

Group Type EXPERIMENTAL

travoprost and timolol maleate fixed combination

Intervention Type DRUG

travoprost 0.004% and timolol maleate 0,5%, 1 eye drop at 8p.m. for 6 months

Interventions

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travoprost and timolol maleate fixed combination

travoprost 0.004% and timolol maleate 0,5%, 1 eye drop at 8p.m. for 6 months

Intervention Type 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

Intervention Type DRUG

bimatoprost and timolol maleate fixed combination

bimatoprost0.03% and timolol maleate 0,5%, 1 eye drop at 8 p.m for 6 months

Intervention Type DRUG

dextran and hypromellose

Dextran 70 and hypromellose, lubricant eye drop at 8 a.m and 8 p.m for 6 months

Intervention Type DRUG

Other Intervention Names

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Duo-travatan Xalacom Ganfort Lacribell

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria:

* Patients were eligible for participation if they met the following inclusion criteria: age older than 18 years, pseudophakia and diagnosis of primary open angle glaucoma (an untreated IOP levels of more then 21 mmHg, specific changes in the optic disc or specific visual fields changes. Optic disc changes were focal notching, optic disc haemorrhage, retinal nerve fiber layer (RNFL)defects, overpass-blood vessel crossing over an area of neuroretinal rim loss.Visual fields changes were the glaucoma hemifield test outside normal limits or a cluster of three or more non-edge points in a typical location of glaucoma or a corrected pattern standard deviation that occurs in less than 5% of normal visual fields

Exclusion Criteria:

* Exclusion criteria included history of uveitis or CME, substantial ocular irritation at baseline, or a history of intraocular surgery or a laser procedure within 6 months of baseline, the presence of systemic disorders that could be associated with uveitis or CME (ie, diabetes mellitus and rheumatologic diseases), presence of age-related macular degeneration and other macular diseases, pregnancy, breastfeeding, and inadequate contraception (in females), treatment with systemic beta-blocker, history of bronchial asthma, chronic obstructive pulmonary disease , sinus bradycardia, second and third degree atrioventricular block , sinoatrial block and functionally significant visual field loss
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Campinas, Brazil

OTHER

Sponsor Role lead

Responsible Party

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Alana Mendonça de Santana

Santana AM

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alana M Santana, MD

Role: PRINCIPAL_INVESTIGATOR

University of Campinas, Brazil

Locations

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Hospital de Clínicas, UNICAMP

Campinas, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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CAAE0319014600010

Identifier Type: OTHER

Identifier Source: secondary_id

CEP424/2010

Identifier Type: -

Identifier Source: org_study_id