Blood-aqueous Barrier Changes After the Use of Timolol and Prostaglandin Analogues Fixed Combination in Pseudophakic Patients With POAG
2 other identifiers
interventional
69
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 25, 2013
CompletedFirst Posted
Study publicly available on registry
November 7, 2013
CompletedNovember 7, 2013
October 1, 2013
9 months
October 25, 2013
October 31, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Flare measurements occurred at baseline; after 15 days; and after 1, 2, 3, 4, 5, and 6 months of treatment
Secondary Outcomes (1)
Change of mean macular thickness values from baseline at 6 months
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
Study Arms (4)
latanoprost and timolol maleate fixed combination
EXPERIMENTALLatanoprost 0.005% and timolol maleate 0,5% fixed combination was dropped once daily at 8 p.m. for 6 months
bimatoprost and timolol maleate fixed combination
EXPERIMENTALbimatoprost 0.03% and timolol maleate 0,5% fixed combination was dropped once daily at 8 p.m. for 6 months
dextran and hypromellose
PLACEBO COMPARATORA 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 and timolol maleate fixed combination
EXPERIMENTALTravoprost 0.004% and timolol maleate 0,5% fixed combination was dropped once daily at 8 p.m. for 6 months
Interventions
travoprost 0.004% and timolol maleate 0,5%, 1 eye drop at 8p.m. for 6 months
Latanoprost 0.005% and timolol maleate 0,5%, 1 eye drop at 8 p.m for 6 months
bimatoprost0.03% and timolol maleate 0,5%, 1 eye drop at 8 p.m for 6 months
Dextran 70 and hypromellose, lubricant eye drop at 8 a.m and 8 p.m for 6 months
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de Clínicas, UNICAMP
Campinas, São Paulo, 13083-888, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alana M Santana, MD
University of Campinas, Brazil
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Santana AM
Study Record Dates
First Submitted
October 25, 2013
First Posted
November 7, 2013
Study Start
October 1, 2011
Primary Completion
July 1, 2012
Study Completion
January 1, 2013
Last Updated
November 7, 2013
Record last verified: 2013-10