Safety and Efficacy Study of DSP-Visulex for the Treatment of Anterior Uveitis

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ClinicalTrials.gov Identifier: NCT02309385

Recruitment Status : Completed

First Posted : December 5, 2014

Last Update Posted : April 27, 2017

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Sponsor:

Collaborator:

National Eye Institute (NEI)

Information provided by (Responsible Party):

Aciont Inc

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Non-Infectious Anterior Uveitis	Drug: 8% Dexamethasone Sodium Phosphate - Visulex Drug: 15% Dexamethasone Sodium Phosphate - Visulex Drug: Prednisolone Acetate (1%) Eye Drops	Phase 1 Phase 2

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	44 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Randomized, Parallel Group, Double-masked, Active-controlled Phase 1/2 Clinical Trial to Evaluate the Efficacy and Safety of Dexamethasone Sodium Phosphate Visulex System for the Treatment of Non-infectious Anterior Uveitis
Actual Study Start Date :	October 2014
Actual Primary Completion Date :	March 3, 2017
Actual Study Completion Date :	March 3, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Dexamethasone Prednisolone Prednisolone acetate Dexamethasone sodium phosphate Sodium phosphate Sodium phosphate, dibasic Phosphate ion

Genetic and Rare Diseases Information Center resources: Acute Graft Versus Host Disease Anterior Uveitis Uveal Diseases Panuveitis

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 8% DSP-Visulex 8% dexamethasone sodium phosphate - Visulex (DSP- Visulex) and placebo eye drops in the affected eye.	Drug: 8% Dexamethasone Sodium Phosphate - Visulex Other Name: 8% DSP- Visulex
Experimental: 15% DSP-Visulex 15% dexamethasone sodium phosphate - Visulex (DSP- Visulex) and placebo eye drops in the affected eye.	Drug: 15% Dexamethasone Sodium Phosphate - Visulex Other Name: 8% DSP- Visulex
Active Comparator: Pred Forte Prednisolone acetate (1%) eye drops and vehicle - Visulex in the affected eye.	Drug: Prednisolone Acetate (1%) Eye Drops Other Name: Pred Forte

Outcome Measures

Primary Outcome Measures :

Proportion of patients with anterior chamber cell ACC grade of zero [ Time Frame: Day 15 ]

Secondary Outcome Measures :

Number of patients with treatment-emergent adverse events [ Time Frame: 29 days ]
Proportion of patients with no uveitis symptoms [ Time Frame: 29 days ]
Proportion of patients with improvement in visual acuity [ Time Frame: 29 days ]
Change in ETDRS letter score
Change from baseline in anterior chamber cell (ACC) grade [ Time Frame: Day 8 ]
Change from baseline in anterior chamber cell (ACC) grade [ Time Frame: Day 15 ]
Change from baseline in anterior chamber cell (ACC) grade [ Time Frame: Day 29 ]
Proportion of patients with anterior chamber cell ACC grade of zero [ Time Frame: Day 8 ]
Proportion of patients with anterior chamber cell ACC grade of zero [ Time Frame: Day 29 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Non-infectious anterior uveitis

Exclusion Criteria:

lntraocular pressure > 25mm Hg OU.
Previous occurrence of an acute episode of anterior uveitis in affected eye(s) within 4 weeks prior to Visit 1.
Historical or active intermediate or posterior uveitis in affected eye(s).
Clear systemic causes of uveitis that may require or have required systemic treatment
Uveitis suspected to have resulted from recent surgery or trauma.
Use of ocular medication of any kind in affected eye(s) more than 2 days prior to Visit 1, excluding artificial tears, topical allergy medications, eyelid scrubs.
Current use, or anticipated initiation during the study, of a corticosteroid or an immunosuppressant agent by any route (oral, inhaled, ocular, dermal). Current stable use is allowed.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02309385

Locations

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United States, Massachusetts
Massachusetts Eye Research and Surgery Institution (MERSI)
Cambridge, Massachusetts, United States, 02142
United States, North Carolina
Charlotte Eye, Ear, Nose, and Throat Associates
Charlotte, North Carolina, United States, 28210
United States, North Dakota
Bergstrom Eye Research
Fargo, North Dakota, United States, 58103
United States, Texas
B-Berger and Associates
Austin, Texas, United States, 78705
Retina and Uveitis Consultants of Texas
San Antonio, Texas, United States, 78240
United States, Utah
Moran Eye Center, University of Utah
Salt Lake City, Utah, United States, 84132

Sponsors and Collaborators

Aciont Inc

National Eye Institute (NEI)

Investigators

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Principal Investigator:	William I Higuchi, PhD	Aciont Inc

More Information

Publications:

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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Responsible Party:	Aciont Inc
ClinicalTrials.gov Identifier:	NCT02309385
Other Study ID Numbers:	DSPV-201 R44EY014772 ( U.S. NIH Grant/Contract )
First Posted:	December 5, 2014 Key Record Dates
Last Update Posted:	April 27, 2017
Last Verified:	April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Keywords provided by Aciont Inc:


uveitis acute uveitis anterior uveitis dexamethasone sodium phosphate	non-infectious uveitis DSP-Visulex Aciont

Additional relevant MeSH terms:

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Uveitis Uveitis, Anterior Iridocyclitis Uveal Diseases Eye Diseases Panuveitis Iris Diseases Dexamethasone Dexamethasone acetate Prednisolone Methylprednisolone Acetate Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone acetate Prednisolone hemisuccinate	Prednisolone phosphate Dexamethasone 21-phosphate BB 1101 Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors

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