Back to resultsBlood-aqueous Barrier Changes After the Use of Timolol and Prostaglandin Analogues Fixed Combination in Pseudophakic Patients With POAG
Primary Purpose
Uveitis, Anterior, Cystoid Macular Edema
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
travoprost and timolol maleate fixed combination
latanoprost and maleate timolol fixed combination
bimatoprost and timolol maleate fixed combination
dextran and hypromellose
Sponsored by
About this trial
This is an interventional treatment trial for Uveitis, Anterior focused on measuring primary open angle glaucoma, timolol, prostaglandin analogues
Eligibility 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
Sites / Locations
- Hospital de Clínicas, UNICAMP
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Experimental
Arm Label
latanoprost and timolol maleate fixed combination
bimatoprost and timolol maleate fixed combination
dextran and hypromellose
travoprost and timolol maleate fixed combination
Arm Description
Latanoprost 0.005% and timolol maleate 0,5% fixed combination was dropped once daily at 8 p.m. for 6 months
bimatoprost 0.03% and timolol maleate 0,5% fixed combination was dropped once daily at 8 p.m. for 6 months
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
Travoprost 0.004% and timolol maleate 0,5% fixed combination was dropped once daily at 8 p.m. for 6 months
Outcomes
Primary Outcome Measures
Change of mean flare values from baseline at 6 months
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
Change of mean macular thickness values from baseline at 6 months
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.
Full Information
NCT ID
NCT01978015
First Posted
October 25, 2013
Last Updated
October 31, 2013
Sponsor
University of Campinas, Brazil
1. Study Identification
Unique Protocol Identification Number
NCT01978015
Brief Title
Blood-aqueous Barrier Changes After the Use of Timolol and Prostaglandin Analogues Fixed Combination in Pseudophakic Patients With POAG
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 Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campinas, Brazil
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveitis, Anterior, Cystoid Macular Edema
Keywords
primary open angle glaucoma, timolol, prostaglandin analogues
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
latanoprost and timolol maleate fixed combination
Arm Type
Experimental
Arm Description
Latanoprost 0.005% and timolol maleate 0,5% fixed combination was dropped once daily at 8 p.m. for 6 months
Arm Title
bimatoprost and timolol maleate fixed combination
Arm Type
Experimental
Arm Description
bimatoprost 0.03% and timolol maleate 0,5% fixed combination was dropped once daily at 8 p.m. for 6 months
Arm Title
dextran and hypromellose
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
travoprost and timolol maleate fixed combination
Arm Type
Experimental
Arm Description
Travoprost 0.004% and timolol maleate 0,5% fixed combination was dropped once daily at 8 p.m. for 6 months
Intervention Type
Drug
Intervention Name(s)
travoprost and timolol maleate fixed combination
Other Intervention Name(s)
Duo-travatan
Intervention Description
travoprost 0.004% and timolol maleate 0,5%, 1 eye drop at 8p.m. for 6 months
Intervention Type
Drug
Intervention Name(s)
latanoprost and maleate timolol fixed combination
Other Intervention Name(s)
Xalacom
Intervention Description
Latanoprost 0.005% and timolol maleate 0,5%, 1 eye drop at 8 p.m for 6 months
Intervention Type
Drug
Intervention Name(s)
bimatoprost and timolol maleate fixed combination
Other Intervention Name(s)
Ganfort
Intervention Description
bimatoprost0.03% and timolol maleate 0,5%, 1 eye drop at 8 p.m for 6 months
Intervention Type
Drug
Intervention Name(s)
dextran and hypromellose
Other Intervention Name(s)
Lacribell
Intervention Description
Dextran 70 and hypromellose, lubricant eye drop at 8 a.m and 8 p.m for 6 months
Primary Outcome Measure Information:
Title
Change of mean flare values from baseline at 6 months
Description
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.
Time Frame
Flare measurements occurred at baseline; after 15 days; and after 1, 2, 3, 4, 5, and 6 months of treatment
Secondary Outcome Measure Information:
Title
Change of mean macular thickness values from baseline at 6 months
Description
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.
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alana M Santana, MD
Organizational Affiliation
University of Campinas, Brazil
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas, UNICAMP
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13083-888
Country
Brazil
12. IPD Sharing Statement
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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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