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

April 25, 2017 updated by: Aciont Inc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • Pred Forte

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with anterior chamber cell ACC grade of zero
Time Frame: Day 15
Day 15

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aciont Inc

Collaborators

National Eye Institute (NEI)

Investigators

  • Principal Investigator: William I Higuchi, PhD, Aciont Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

March 3, 2017

Study Completion (Actual)

March 3, 2017

Study Registration Dates

First Submitted

December 1, 2014

First Submitted That Met QC Criteria

December 4, 2014

First Posted (Estimate)

December 5, 2014

Study Record Updates

Last Update Posted (Actual)

April 27, 2017

Last Update Submitted That Met QC Criteria

April 25, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DSPV-201
  • R44EY014772 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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