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The purpose of this study is to evaluate the safety and efficacy of BETOPTIC S and Timolol Gel-forming solution in pediatric patients. Patients will dose with study drug at 8 am and 8 pm daily for twelve weeks. Patients will have vision tested, slit lamp exam, blood pressure and pulse checks at each visit. Patients will have a dilated fundus exam and corneal measurements taken at first and last visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Betaxolol | Experimental | Two doses daily for 12 weeks |
|
| TGFS 0.25% | Experimental | Two doses daily for 12 weeks |
|
| TGFS 0.5% | Experimental | Two doses daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BETOPTIC S (betaxolol HCl) | Drug | betaxolol HC) |
| |
| Timolol Gel-forming Solution (TGFS) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in IOP | Up to Week 12 |
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INCLUSION:
EXCLUSION:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Call Center | Fort Worth | Texas | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19683191 | Result | Plager DA, Whitson JT, Netland PA, Vijaya L, Sathyan P, Sood D, Krishnadas SR, Robin AL, Gross RD, Scheib SA, Scott H, Dickerson JE; BETOPTIC S Pediatric Study Group. Betaxolol hydrochloride ophthalmic suspension 0.25% and timolol gel-forming solution 0.25% and 0.5% in pediatric glaucoma: a randomized clinical trial. J AAPOS. 2009 Aug;13(4):384-90. doi: 10.1016/j.jaapos.2009.04.017. |
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| Drug |
timolol maleate 0.25% and 0.5% |
|
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D015784 | Betaxolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
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