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Trial record 19 of 400 for:    sodium phosphate

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

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ClinicalTrials.gov Identifier: NCT02309385
Recruitment Status : Completed
First Posted : December 5, 2014
Last Update Posted : April 27, 2017
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
Aciont Inc

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.

Condition or disease Intervention/treatment Phase
Non-Infectious Anterior Uveitis Drug: 8% Dexamethasone Sodium Phosphate - Visulex Drug: 15% Dexamethasone Sodium Phosphate - Visulex Drug: Prednisolone Acetate (1%) Eye Drops Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 2014
Actual Primary Completion Date : March 3, 2017
Actual Study Completion Date : March 3, 2017


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 Name: 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 Name: 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 Name: Pred Forte




Primary Outcome Measures :
  1. Proportion of patients with anterior chamber cell ACC grade of zero [ Time Frame: Day 15 ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02309385


Locations
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United States, Massachusetts
Massachusetts Eye Research and Surgery Institution (MERSI)
Cambridge, Massachusetts, United States, 02142
United States, North Carolina
Charlotte Eye, Ear, Nose, and Throat Associates
Charlotte, North Carolina, United States, 28210
United States, North Dakota
Bergstrom Eye Research
Fargo, North Dakota, United States, 58103
United States, Texas
B-Berger and Associates
Austin, Texas, United States, 78705
Retina and Uveitis Consultants of Texas
San Antonio, Texas, United States, 78240
United States, Utah
Moran Eye Center, University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Aciont Inc
National Eye Institute (NEI)
Investigators
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Principal Investigator: William I Higuchi, PhD Aciont Inc

Publications:

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Responsible Party: Aciont Inc
ClinicalTrials.gov Identifier: NCT02309385     History of Changes
Other Study ID Numbers: DSPV-201
R44EY014772 ( U.S. NIH Grant/Contract )
First Posted: December 5, 2014    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Aciont Inc:
uveitis
acute uveitis
anterior uveitis
dexamethasone sodium phosphate
non-infectious uveitis
DSP-Visulex
Aciont

Additional relevant MeSH terms:
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Prednisolone phosphate
Dexamethasone 21-phosphate
Uveitis
Uveitis, Anterior
Iridocyclitis
Uveal Diseases
Eye Diseases
Panuveitis
Iris Diseases
Dexamethasone
Dexamethasone acetate
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
BB 1101
Ophthalmic Solutions
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents