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| ID | Type | Description | Link |
|---|---|---|---|
| R44EY014772 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
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The purpose of this study is to determine the efficacy, safety, and tolerability of dexamethasone sodium phosphate Visulex (DSP-Visulex) after repeated-dose administration in patients with acute anterior uveitis.
This is a multicenter, randomized, parallel group, double-masked, active- controlled study. Subjects will be enrolled and randomized to either 8 % or 15% DSP-Visulex with placebo drops or Vehicle-Visulex (V-Visulex) with prednisolone acetate 1% eye drops. All subjects will receive concomitant treatment with cyclopentolate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 8% DSP-Visulex | Experimental | 8% dexamethasone sodium phosphate - Visulex (DSP- Visulex) and placebo eye drops in the affected eye. |
|
| 15% DSP-Visulex | Experimental | 15% dexamethasone sodium phosphate - Visulex (DSP- Visulex) and placebo eye drops in the affected eye. |
|
| Pred Forte | Active Comparator | Prednisolone acetate (1%) eye drops and vehicle - Visulex in the affected eye. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 8% Dexamethasone Sodium Phosphate - Visulex | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with anterior chamber cell ACC grade of zero | Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with treatment-emergent adverse events | 29 days | |
| Proportion of patients with no uveitis symptoms | 29 days | |
| Proportion of patients with improvement in visual acuity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William I Higuchi, PhD | Aciont Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts Eye Research and Surgery Institution (MERSI) | Cambridge | Massachusetts | 02142 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20702826 | Background | Chang-Lin JE, Attar M, Acheampong AA, Robinson MR, Whitcup SM, Kuppermann BD, Welty D. Pharmacokinetics and pharmacodynamics of a sustained-release dexamethasone intravitreal implant. Invest Ophthalmol Vis Sci. 2011 Jan 5;52(1):80-6. doi: 10.1167/iovs.10-5285. | |
| 15634032 | Background | Czock D, Keller F, Rasche FM, Haussler U. Pharmacokinetics and pharmacodynamics of systemically administered glucocorticoids. Clin Pharmacokinet. 2005;44(1):61-98. doi: 10.2165/00003088-200544010-00003. |
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| 15% Dexamethasone Sodium Phosphate - Visulex |
| Drug |
|
|
| Prednisolone Acetate (1%) Eye Drops | Drug |
|
|
Change in ETDRS letter score |
| 29 days |
| Change from baseline in anterior chamber cell (ACC) grade | Day 8 |
| Change from baseline in anterior chamber cell (ACC) grade | Day 15 |
| Change from baseline in anterior chamber cell (ACC) grade | Day 29 |
| Proportion of patients with anterior chamber cell ACC grade of zero | Day 8 |
| Proportion of patients with anterior chamber cell ACC grade of zero | Day 29 |
| Charlotte Eye, Ear, Nose, and Throat Associates |
| Charlotte |
| North Carolina |
| 28210 |
| United States |
| Bergstrom Eye Research | Fargo | North Dakota | 58103 | United States |
| B-Berger and Associates | Austin | Texas | 78705 | United States |
| Retina and Uveitis Consultants of Texas | San Antonio | Texas | 78240 | United States |
| Moran Eye Center, University of Utah | Salt Lake City | Utah | 84132 | United States |
| 20648092 | Background | Cunningham ET Jr, Wender JD. Practical approach to the use of corticosteroids in patients with uveitis. Can J Ophthalmol. 2010 Aug;45(4):352-8. doi: 10.3129/i10-081. |
| 16235062 | Background | Gan IM, Ugahary LC, van Dissel JT, Feron E, Peperkamp E, Veckeneer M, Mulder PG, Platenkamp GJ, van Meurs JC. Intravitreal dexamethasone as adjuvant in the treatment of postoperative endophthalmitis: a prospective randomized trial. Graefes Arch Clin Exp Ophthalmol. 2005 Dec;243(12):1200-5. doi: 10.1007/s00417-005-0133-1. Epub 2005 Oct 19. |
| 13851186 | Background | GORDON DM. Use of dexamethasone in eye disease. J Am Med Assoc. 1960 Jan 23;172:311-2. doi: 10.1001/jama.1960.03020040009003. No abstract available. |
| 18665810 | Background | Miller DJ, Li SK, Tuitupou AL, Kochambilli RP, Papangkorn K, Mix DC Jr, Higuchi WI, Higuchi JW. Passive and oxymetazoline-enhanced delivery with a lens device: pharmacokinetics and efficacy studies with rabbits. J Ocul Pharmacol Ther. 2008 Aug;24(4):385-91. doi: 10.1089/jop.2007.0116. |
| 16236742 | Background | Rhen T, Cidlowski JA. Antiinflammatory action of glucocorticoids--new mechanisms for old drugs. N Engl J Med. 2005 Oct 20;353(16):1711-23. doi: 10.1056/NEJMra050541. No abstract available. |
| 3593899 | Background | Rohdewald P, Mollmann H, Barth J, Rehder J, Derendorf H. Pharmacokinetics of dexamethasone and its phosphate ester. Biopharm Drug Dispos. 1987 May-Jun;8(3):205-12. doi: 10.1002/bdd.2510080302. |
| 10458175 | Background | Weijtens O, Feron EJ, Schoemaker RC, Cohen AF, Lentjes EG, Romijn FP, van Meurs JC. High concentration of dexamethasone in aqueous and vitreous after subconjunctival injection. Am J Ophthalmol. 1999 Aug;128(2):192-7. doi: 10.1016/s0002-9394(99)00129-4. |
| 9625551 | Background | Weijtens O, Schoemaker RC, Cohen AF, Romijn FP, Lentjes EG, van Rooij J, van Meurs JC. Dexamethasone concentration in vitreous and serum after oral administration. Am J Ophthalmol. 1998 May;125(5):673-9. doi: 10.1016/s0002-9394(98)00003-8. |
| 12359610 | Background | Weijtens O, Schoemaker RC, Romijn FP, Cohen AF, Lentjes EG, van Meurs JC. Intraocular penetration and systemic absorption after topical application of dexamethasone disodium phosphate. Ophthalmology. 2002 Oct;109(10):1887-91. doi: 10.1016/s0161-6420(02)01176-4. |
| 9063245 | Background | Weijtens O, van der Sluijs FA, Schoemaker RC, Lentjes EG, Cohen AF, Romijn FP, van Meurs JC. Peribulbar corticosteroid injection: vitreal and serum concentrations after dexamethasone disodium phosphate injection. Am J Ophthalmol. 1997 Mar;123(3):358-63. doi: 10.1016/s0002-9394(14)70131-x. |
| ID | Term |
|---|---|
| D014605 | Uveitis |
| D014606 | Uveitis, Anterior |
| ID | Term |
|---|---|
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D015864 | Panuveitis |
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| ID | Term |
|---|---|
| C009935 | prednisolone acetate |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
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