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

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ClinicalTrials.gov Identifier: NCT01978015
Recruitment Status : Completed
First Posted : November 7, 2013
Last Update Posted : November 7, 2013
Sponsor:
Information provided by (Responsible Party):
Alana Mendonça de Santana, University of Campinas, Brazil

Brief 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).

Condition or disease Intervention/treatment Phase
Uveitis, Anterior Cystoid Macular Edema Drug: travoprost and timolol maleate fixed combination Drug: latanoprost and maleate timolol fixed combination Drug: bimatoprost and timolol maleate fixed combination Drug: dextran and hypromellose Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Blood-aqueous Barrier Changes After the Use of Timolol and Prostaglandin Analogues Fixed Combination in Pseudophakic Patients With Primary Open Angle Glaucoma
Study Start Date : October 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : January 2013


Arm Intervention/treatment
Experimental: 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
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
Other Name: Xalacom

Experimental: 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
Drug: bimatoprost and timolol maleate fixed combination
bimatoprost0.03% and timolol maleate 0,5%, 1 eye drop at 8 p.m for 6 months
Other Name: Ganfort

Placebo Comparator: 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
Drug: dextran and hypromellose
Dextran 70 and hypromellose, lubricant eye drop at 8 a.m and 8 p.m for 6 months
Other Name: Lacribell

Experimental: 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
Drug: travoprost and timolol maleate fixed combination
travoprost 0.004% and timolol maleate 0,5%, 1 eye drop at 8p.m. for 6 months
Other Name: Duo-travatan




Primary Outcome Measures :
  1. Change of mean flare values from baseline at 6 months [ Time Frame: Flare measurements occurred at baseline; after 15 days; and after 1, 2, 3, 4, 5, and 6 months of treatment ]
    A flare measure of a laser flare meter (FM 500; Kowa Co Ltd, Tokyo, Japan) was used to determine the status of the blood-aqueous barrier at all follow-up visits. According to information provided by the manufacturer, flare readings greater than 26 photon counts per millisecond (p/ms) are indicative of a disruption in the blood-aqueous barrier.


Secondary Outcome Measures :
  1. Change of mean macular thickness values from baseline at 6 months [ Time Frame: Macular optical coherence tomography images were taken at baseline, after one month and six months of treatment, or if a patient has reduced visual acuity during follow-up ]
    Foveal macular thickness wiht Spectral Domain Optical Coherence Tomography (Cirrus Model 4000; Carl Zeiss Meditec, Dublin, California, USA) examination was conducted to investigate the occurrence of cystoid macular edema (CME). If CME was detected, the patient was instructed to discontinue taking the medication and a nonsteroidal anti-inflammatory drug was prescribed.



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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01978015


Locations
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Brazil
Hospital de Clínicas, UNICAMP
Campinas, São Paulo, Brazil, 13083-888
Sponsors and Collaborators
University of Campinas, Brazil
Investigators
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Principal Investigator: Alana M Santana, MD University of Campinas, Brazil
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Responsible Party: Alana Mendonça de Santana, Santana AM, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT01978015    
Other Study ID Numbers: CEP424/2010
CAAE0319014600010 ( Other Identifier: CAAE0319014600010 )
First Posted: November 7, 2013    Key Record Dates
Last Update Posted: November 7, 2013
Last Verified: October 2013
Keywords provided by Alana Mendonça de Santana, University of Campinas, Brazil:
primary open angle glaucoma
timolol
prostaglandin analogues
Additional relevant MeSH terms:
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Macular Edema
Uveitis
Uveitis, Anterior
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Uveal Diseases
Panuveitis
Timolol
Latanoprost
Bimatoprost
Travoprost
Dextrans
Maleic acid
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Enzyme Inhibitors
Anticoagulants
Plasma Substitutes
Blood Substitutes