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| ID | Type | Description | Link |
|---|---|---|---|
| CAAE0319014600010 | Other Identifier | CAAE0319014600010 |
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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| latanoprost and timolol maleate fixed combination | Experimental | Latanoprost 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 | Experimental | bimatoprost 0.03% and timolol maleate 0,5% fixed combination was dropped once daily at 8 p.m. for 6 months |
|
| dextran and hypromellose | Placebo Comparator | 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 |
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| travoprost and timolol maleate fixed combination | Experimental | Travoprost 0.004% and timolol maleate 0,5% fixed combination was dropped once daily at 8 p.m. for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| travoprost and timolol maleate fixed combination | Drug | travoprost 0.004% and timolol maleate 0,5%, 1 eye drop at 8p.m. for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alana M Santana, MD | University of Campinas, Brazil | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de ClÃnicas, UNICAMP | Campinas | São Paulo | 13083-888 | Brazil |
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| latanoprost and maleate timolol fixed combination | Drug | Latanoprost 0.005% and timolol maleate 0,5%, 1 eye drop at 8 p.m for 6 months |
|
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| bimatoprost and timolol maleate fixed combination | Drug | bimatoprost0.03% and timolol maleate 0,5%, 1 eye drop at 8 p.m for 6 months |
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| dextran and hypromellose | Drug | Dextran 70 and hypromellose, lubricant eye drop at 8 a.m and 8 p.m for 6 months |
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| 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 |
| ID | Term |
|---|---|
| D014606 | Uveitis, Anterior |
| D008269 | Macular Edema |
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D015864 | Panuveitis |
| D014605 | Uveitis |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
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| ID | Term |
|---|---|
| D000069557 | Travoprost |
| D000077338 | Latanoprost |
| C571753 | Xalacom |
| D000069580 | Bimatoprost |
| C571755 | Ganfort |
| D003911 | Dextrans |
| D065347 | Hypromellose Derivatives |
| ID | Term |
|---|---|
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D002482 | Cellulose |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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