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Non-Infectious Anterior UveitisPhase 1/2NCT02309385

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

A Phase 1/2 study testing 8% Dexamethasone Sodium Phosphate - Visulex, 15% Dexamethasone Sodium Phosphate - Visulex and Prednisolone Acetate (1%) Eye Drops in people with Non-Infectious Anterior Uveitis, run by Aciont Inc at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Infectious Anterior Uveitis
What is being tested?
8% Dexamethasone Sodium Phosphate - Visulex, 15% Dexamethasone Sodium Phosphate - Visulex and Prednisolone Acetate (1%) Eye Drops
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
6 sitesUnited States
Study dates
Oct 2014to 3 Mar 2017
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Non-infectious anterior uveitis

Who cannot join

  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • B-Berger and Associates

    Austin, Texas, 78705

  • Massachusetts Eye Research and Surgery Institution (MERSI)

    Cambridge, Massachusetts, 02142

  • Charlotte Eye, Ear, Nose, and Throat Associates

    Charlotte, North Carolina, 28210

  • Bergstrom Eye Research

    Fargo, North Dakota, 58103

  • Moran Eye Center, University of Utah

    Salt Lake City, Utah, 84132

  • Retina and Uveitis Consultants of Texas

    San Antonio, Texas, 78240

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
8% Dexamethasone Sodium Phosphate - Visulex, 15% Dexamethasone Sodium Phosphate - Visulex, Prednisolone Acetate (1%) Eye Drops
Keywords
uveitis, acute uveitis, anterior uveitis, dexamethasone sodium phosphate, non-infectious uveitis, DSP-Visulex, Aciont
Medical subject headings
Uveitis, Uveitis, Anterior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 8% Dexamethasone Sodium Phosphate - VisulexDrug

    Also called 8% DSP- Visulex

  • 15% Dexamethasone Sodium Phosphate - VisulexDrug

    Also called 8% DSP- Visulex

  • Prednisolone Acetate (1%) Eye DropsDrug

    Also called Pred Forte

Study groups in NCT02309385
Study groupRoleWhat they receive
8% DSP-VisulexExperimental8% dexamethasone sodium phosphate - Visulex (DSP- Visulex) and placebo eye drops in the affected eye.
Receives: Drug: 8% Dexamethasone Sodium Phosphate - Visulex
15% DSP-VisulexExperimental15% dexamethasone sodium phosphate - Visulex (DSP- Visulex) and placebo eye drops in the affected eye.
Receives: Drug: 15% Dexamethasone Sodium Phosphate - Visulex
Pred ForteActive comparatorPrednisolone acetate (1%) eye drops and vehicle - Visulex in the affected eye.
Receives: Drug: Prednisolone Acetate (1%) Eye Drops

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Day 15

Secondary outcomes (8)

  1. Number of patients with treatment-emergent adverse events

    Measured: 29 days

  2. Proportion of patients with no uveitis symptoms

    Measured: 29 days

  3. Proportion of patients with improvement in visual acuity

    Change in ETDRS letter score

    Measured: 29 days

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

    Measured: Day 8

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

    Measured: Day 15

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

    Measured: Day 29

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

    Measured: Day 8

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

    Measured: Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2014 (estimated)
  2. Study startOct 2014
  3. Primary completion3 Mar 2017
  4. Study completion3 Mar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02309385
Sponsor's protocol ID
DSPV-201
Other IDs
R44EY014772
Status last verified
Apr 2017
First submitted
1 Dec 2014
Last updated
27 Apr 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 20702826

  • 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.

    PubMed 15634032

  • 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.

    PubMed 20648092

  • 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.

    PubMed 16235062

  • 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.

    PubMed 13851186

  • 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.

    PubMed 18665810

  • 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.

    PubMed 16236742

  • 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.

    PubMed 3593899

  • 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.

    PubMed 10458175

  • 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.

    PubMed 9625551

  • 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.

    PubMed 12359610

  • 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.

    PubMed 9063245

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 8% Dexamethasone Sodium Phosphate - Visulex, 15% Dexamethasone Sodium Phosphate - Visulex and Prednisolone Acetate (1%) Eye Drops in people with Non-Infectious Anterior Uveitis, run by Aciont Inc at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with anterior chamber cell ACC grade of zero (time frame: Day 15). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02309385, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2017.

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