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

NCT02309385 | Completed Phase 1

• 2 other identifiers: DSPV-201R44EY014772
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 6

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.

Conditions

Non-Infectious Anterior Uveitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with anterior chamber cell ACC grade of zero

  Day 15

Secondary Outcomes (8)

• 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

  29 days

• Change from baseline in anterior chamber cell (ACC) grade

  Day 8

• Change from baseline in anterior chamber cell (ACC) grade

  Day 15

Study Arms (3)

8% DSP-Visulex

EXPERIMENTAL

8% dexamethasone sodium phosphate - Visulex (DSP- Visulex) and placebo eye drops in the affected eye.

Drug: 8% Dexamethasone Sodium Phosphate - Visulex

15% DSP-Visulex

EXPERIMENTAL

15% dexamethasone sodium phosphate - Visulex (DSP- Visulex) and placebo eye drops in the affected eye.

Drug: 15% Dexamethasone Sodium Phosphate - Visulex

Pred Forte

ACTIVE COMPARATOR

Prednisolone acetate (1%) eye drops and vehicle - Visulex in the affected eye.

Drug: Prednisolone Acetate (1%) Eye Drops

Interventions

8% Dexamethasone Sodium Phosphate - Visulex DRUG

Also known as: 8% DSP- Visulex

8% DSP-Visulex

15% Dexamethasone Sodium Phosphate - Visulex DRUG

Also known as: 8% DSP- Visulex

15% DSP-Visulex

Prednisolone Acetate (1%) Eye Drops DRUG

Also known as: Pred Forte

Pred Forte

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-infectious anterior uveitis

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aciont Inc: lead
• National Eye Institute (NEI): collaborator

Study Sites (6)

Massachusetts Eye Research and Surgery Institution (MERSI)

Cambridge, Massachusetts, 02142, United States

Location

Charlotte Eye, Ear, Nose, and Throat Associates

Charlotte, North Carolina, 28210, United States

Location

Bergstrom Eye Research

Fargo, North Dakota, 58103, United States

Location

B-Berger and Associates

Austin, Texas, 78705, United States

Location

Retina and Uveitis Consultants of Texas

San Antonio, Texas, 78240, United States

Location

Moran Eye Center, University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related 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.

  PMID: 20702826 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.

  PMID: 15634032 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.

  PMID: 20648092 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.

  PMID: 16235062 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.

  PMID: 13851186 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.

  PMID: 18665810 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.

  PMID: 16236742 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.

  PMID: 3593899 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.

  PMID: 10458175 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.

  PMID: 9625551 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.

  PMID: 12359610 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.

  PMID: 9063245 BACKGROUND

MeSH Terms

Conditions

Uveitis; Uveitis, Anterior

Interventions

prednisolone acetate; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases; Panuveitis

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• William I Higuchi, PhD

  Aciont Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2014
• First Posted: December 5, 2014
• Study Start: October 1, 2014
• Primary Completion: March 3, 2017
• Study Completion: March 3, 2017
• Last Updated: April 27, 2017

Record last verified: 2017-04

Locations

US (6)