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Completed

NCT Number: NCT02309385

Safety and Efficacy Study of DSP-Visulex for the Treatment of 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.

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Key information

Conditions

Non-infectious Anterior Uveitis Eye Diseases Panuveitis Uveal Diseases Uveitis Uveitis, Anterior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Massachusetts Eye Research and Surgery Institution (MERSI), Cambridge, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

8% Dexamethasone Sodium Phosphate - Visulex

Drug

Other names: 8% DSP- Visulex

15% Dexamethasone Sodium Phosphate - Visulex

Drug

Other names: 8% DSP- Visulex

Prednisolone Acetate (1%) Eye Drops

Drug

Other names: Pred Forte

Primary outcomes

  1. Proportion of patients with anterior chamber cell ACC grade of zero

    Time frame: Day 15

Secondary outcomes

  1. Number of patients with treatment-emergent adverse events

    Time frame: 29 days

  2. Proportion of patients with no uveitis symptoms

    Time frame: 29 days

  3. Proportion of patients with improvement in visual acuity

    Time frame: 29 days

    Change in ETDRS letter score

  4. Change from baseline in anterior chamber cell (ACC) grade

    Time frame: Day 8

  5. Change from baseline in anterior chamber cell (ACC) grade

    Time frame: Day 15

  6. Change from baseline in anterior chamber cell (ACC) grade

    Time frame: Day 29

  7. Proportion of patients with anterior chamber cell ACC grade of zero

    Time frame: Day 8

  8. Proportion of patients with anterior chamber cell ACC grade of zero

    Time frame: Day 29

Sponsors and collaborators

Lead sponsor

Aciont Inc

Other

Collaborators

  • National Eye Institute (NEI)

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 5, 2014
Registry last updated
Apr 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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