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

Non-Infectious Anterior Uveitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02309385
• Other study ID #: DSPV-201
• Secondary ID: R44EY014772
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 1, 2014
• Last updated: April 25, 2017
• Start date: October 2014
• Est. completion date: March 3, 2017

Study information

• Verified date: April 2017
• Source: Aciont Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 3, 2017
• Est. primary completion date: March 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Iridocyclitis
• Non-Infectious Anterior Uveitis
• Uveitis
• Uveitis, Anterior

Intervention

Drug:
• 8% Dexamethasone Sodium Phosphate - Visulex

• 15% Dexamethasone Sodium Phosphate - Visulex

• Prednisolone Acetate (1%) Eye Drops

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Aciont Inc	National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View Citation

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. — View Citation

Czock D, Keller F, Rasche FM, Häussler U. Pharmacokinetics and pharmacodynamics of systemically administered glucocorticoids. Clin Pharmacokinet. 2005;44(1):61-98. Review. — View Citation

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. Epub 2005 Oct 19. — View Citation

GORDON DM. Use of dexamethasone in eye disease. J Am Med Assoc. 1960 Jan 23;172:311-2. — View Citation

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. — View Citation

Rhen T, Cidlowski JA. Antiinflammatory action of glucocorticoids--new mechanisms for old drugs. N Engl J Med. 2005 Oct 20;353(16):1711-23. Review. — View Citation

Rohdewald P, Möllmann H, Barth J, Rehder J, Derendorf H. Pharmacokinetics of dexamethasone and its phosphate ester. Biopharm Drug Dispos. 1987 May-Jun;8(3):205-12. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with anterior chamber cell ACC grade of zero		Day 15
Secondary	Number of patients with treatment-emergent adverse events		29 days
Secondary	Proportion of patients with no uveitis symptoms		29 days
Secondary	Proportion of patients with improvement in visual acuity	Change in ETDRS letter score	29 days
Secondary	Change from baseline in anterior chamber cell (ACC) grade		Day 8
Secondary	Change from baseline in anterior chamber cell (ACC) grade		Day 15
Secondary	Change from baseline in anterior chamber cell (ACC) grade		Day 29
Secondary	Proportion of patients with anterior chamber cell ACC grade of zero		Day 8
Secondary	Proportion of patients with anterior chamber cell ACC grade of zero		Day 29