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

Primary Purpose

Non-Infectious Anterior Uveitis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
8% Dexamethasone Sodium Phosphate - Visulex
15% Dexamethasone Sodium Phosphate - Visulex
Prednisolone Acetate (1%) Eye Drops
Sponsored by
Aciont Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Infectious Anterior Uveitis focused on measuring uveitis, acute uveitis, anterior uveitis, dexamethasone sodium phosphate, non-infectious uveitis, DSP-Visulex, Aciont

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Massachusetts Eye Research and Surgery Institution (MERSI)
  • Charlotte Eye, Ear, Nose, and Throat Associates
  • Bergstrom Eye Research
  • B-Berger and Associates
  • Retina and Uveitis Consultants of Texas
  • Moran Eye Center, University of Utah

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

8% DSP-Visulex

15% DSP-Visulex

Pred Forte

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Proportion of patients with anterior chamber cell ACC grade of zero

Secondary Outcome Measures

Number of patients with treatment-emergent adverse events
Proportion of patients with no uveitis symptoms
Proportion of patients with improvement in visual acuity
Change in ETDRS letter score
Change from baseline in anterior chamber cell (ACC) grade
Change from baseline in anterior chamber cell (ACC) grade
Change from baseline in anterior chamber cell (ACC) grade
Proportion of patients with anterior chamber cell ACC grade of zero
Proportion of patients with anterior chamber cell ACC grade of zero

Full Information

First Posted
December 1, 2014
Last Updated
April 25, 2017
Sponsor
Aciont Inc
Collaborators
National Eye Institute (NEI)
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1. Study Identification

Unique Protocol Identification Number
NCT02309385
Brief Title
Safety and Efficacy Study of DSP-Visulex for the Treatment of Anterior Uveitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
March 3, 2017 (Actual)
Study Completion Date
March 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aciont Inc
Collaborators
National Eye Institute (NEI)

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Infectious Anterior Uveitis
Keywords
uveitis, acute uveitis, anterior uveitis, dexamethasone sodium phosphate, non-infectious uveitis, DSP-Visulex, Aciont

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
8% DSP-Visulex
Arm Type
Experimental
Arm Description
8% dexamethasone sodium phosphate - Visulex (DSP- Visulex) and placebo eye drops in the affected eye.
Arm Title
15% DSP-Visulex
Arm Type
Experimental
Arm Description
15% dexamethasone sodium phosphate - Visulex (DSP- Visulex) and placebo eye drops in the affected eye.
Arm Title
Pred Forte
Arm Type
Active Comparator
Arm Description
Prednisolone acetate (1%) eye drops and vehicle - Visulex in the affected eye.
Intervention Type
Drug
Intervention Name(s)
8% Dexamethasone Sodium Phosphate - Visulex
Other Intervention Name(s)
8% DSP- Visulex
Intervention Type
Drug
Intervention Name(s)
15% Dexamethasone Sodium Phosphate - Visulex
Other Intervention Name(s)
8% DSP- Visulex
Intervention Type
Drug
Intervention Name(s)
Prednisolone Acetate (1%) Eye Drops
Other Intervention Name(s)
Pred Forte
Primary Outcome Measure Information:
Title
Proportion of patients with anterior chamber cell ACC grade of zero
Time Frame
Day 15
Secondary Outcome Measure Information:
Title
Number of patients with treatment-emergent adverse events
Time Frame
29 days
Title
Proportion of patients with no uveitis symptoms
Time Frame
29 days
Title
Proportion of patients with improvement in visual acuity
Description
Change in ETDRS letter score
Time Frame
29 days
Title
Change from baseline in anterior chamber cell (ACC) grade
Time Frame
Day 8
Title
Change from baseline in anterior chamber cell (ACC) grade
Time Frame
Day 15
Title
Change from baseline in anterior chamber cell (ACC) grade
Time Frame
Day 29
Title
Proportion of patients with anterior chamber cell ACC grade of zero
Time Frame
Day 8
Title
Proportion of patients with anterior chamber cell ACC grade of zero
Time Frame
Day 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William I Higuchi, PhD
Organizational Affiliation
Aciont Inc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts Eye Research and Surgery Institution (MERSI)
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02142
Country
United States
Facility Name
Charlotte Eye, Ear, Nose, and Throat Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Bergstrom Eye Research
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
B-Berger and Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Retina and Uveitis Consultants of Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Moran Eye Center, University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
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20702826
Citation
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Citation
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Citation
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Safety and Efficacy Study of DSP-Visulex for the Treatment of Anterior Uveitis

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