UveitisPhase 3NCT00407056
Study of Difluprednate Ophthalmic Emulsion in the Treatment of Severe Uveitis
A Phase 3 study testing Difluprednate Ophthalmic Emulsion in people with Uveitis and Panuveitis, run by Sirion Therapeutics, Inc..
Trial summary
The purpose of this phase 3 open-labeled study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of severe uveitis. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Uveitis, Panuveitis
- What is being tested?
- Difluprednate Ophthalmic Emulsion
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Aug 2002to Jun 2003
- Phase
- Phase 3
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with a diagnosis of endogenous anterior uveitis or panuveitis
- Patients with ≥ 50 anterior chamber cells as observed by slit lamp microscopy (criterion for evaluation of signs 4)
- Patients requiring more frequent instillation of 0.1% betamethasone sodium phosphate ophthalmic solution than the regular frequency specified in its dosage and administration (3 - 4 times/day)
- Patients aged ≥ 12 years (on the day of obtaining informed consent) who were able to actuate symptoms
- Patients giving written informed consent prior to initiation of the study
Who cannot join
- Patients who did not meet all of the above inclusion criteria
- Patients initiating treatment with systemic administration of any corticosteroid, non-steroidal anti-inflammatory drug, antiphlogistic enzyme or immunosuppressive drug within 2 weeks before instillation of the investigational drug
- Patients receiving topical injection of any corticosteroid in eyes before instillation of the investigational product(solution formulation: within 1 week before instillation of the investigational product, depot formulation: within 2 weeks before instillation of the investigational product)
- Patients receiving instillation of any corticosteroid, non-steroidal anti-inflammatory ophthalmic solution or antiphologistic enzyme within 12 hours before instillation of the investigational drug
- Patients with glaucoma or ocular hypertension
- Patients with corneal erosion or corneal ulcer
Show all 11Show fewer
- Patients with any viral, bacterial or fungal keratoconjunctival disease or suspected with eye infection
- Patients with allergy to similar drugs of difluprednate
- Patients requiring use of contact lens during the study period
- Women who were or might be pregnant, or lactating women
- Patients participating in another clinical study within 3 months before initiation of the present study
About this study
Official title: Phase 3 Open-Labeled Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Severe Anterior Uveitis (Including Panuveitis).
The purpose of this phase 3 open-labeled study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of severe uveitis.
Read the detailed description
The objective of this phase 3 study is to assess the efficacy and safety of 0.05% difluprednate ophthalmic emulsion in patients with severe endogenous anterior uveitis with an open-labeled, no-controlled and no-randomized design.
- Conditions
- Uveitis, Panuveitis
- Being tested
- Difluprednate Ophthalmic Emulsion
- Medical subject headings
- Uveitis, Panuveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Difluprednate Ophthalmic EmulsionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The anterior chamber cell score was compared between baseline and Day 14.
Secondary outcomes (7)
The anterior chamber cell score was compared between baseline and Days 3 and 7.
The total symptom score (sum of eye pain, photophobia, blurred
vision, foreign body sensation and lacrimation scores) and total
sign score (sum of anterior chamber cell, anterior chamber flare,
ciliary hyperemia, keratic precipitate and synechia of iris and
posterior scores) were compared between baseline and Days 3, 7
and 14.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2006 (estimated)
- Study startAug 2002
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UveitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Sirion Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Shigeaki Ono, Principal investigator, Department of Ophthalmology and Visual Science, Graduate School of Medicine, Hokkaido University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00407056
- Sponsor's protocol ID
- SJE2079/3-02-PC
- Status last verified
- Nov 2006
- First submitted
- 29 Nov 2006
- Last updated
- 4 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Open-Labeled Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Severe Anterior Uveitis (Including Panuveitis).
- ClinicalTrials.gov ID
- NCT00407056
- Acronym / sponsor ID
- SJE2079/3-02-PC
- Conditions
- Uveitis, Panuveitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Sirion Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2002
- Study completion
- Jun 2003
- First posted
- 4 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this phase 3 open-labeled study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of severe uveitis.
Detailed description
The objective of this phase 3 study is to assess the efficacy and safety of 0.05% difluprednate ophthalmic emulsion in patients with severe endogenous anterior uveitis with an open-labeled, no-controlled and no-randomized design.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with a diagnosis of endogenous anterior uveitis or panuveitis
- Patients with ≥ 50 anterior chamber cells as observed by slit lamp microscopy (criterion for evaluation of signs 4)
- Patients requiring more frequent instillation of 0.1% betamethasone sodium phosphate ophthalmic solution than the regular frequency specified in its dosage and administration (3 - 4 times/day)
- Patients aged ≥ 12 years (on the day of obtaining informed consent) who were able to actuate symptoms
- Patients giving written informed consent prior to initiation of the study
Key exclusion criteria (11 listed)
- Patients who did not meet all of the above inclusion criteria
- Patients initiating treatment with systemic administration of any corticosteroid, non-steroidal anti-inflammatory drug, antiphlogistic enzyme or immunosuppressive drug within 2 weeks before instillation of the investigational drug
- Patients receiving topical injection of any corticosteroid in eyes before instillation of the investigational product(solution formulation: within 1 week before instillation of the investigational product, depot formulation: within 2 weeks before instillation of the investigational product)
- Patients receiving instillation of any corticosteroid, non-steroidal anti-inflammatory ophthalmic solution or antiphologistic enzyme within 12 hours before instillation of the investigational drug
- Patients with glaucoma or ocular hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Difluprednate Ophthalmic Emulsion | Drug | – |
Primary outcome
The anterior chamber cell score was compared between baseline and Day 14.
7 secondary outcomes
The anterior chamber cell score was compared between baseline and Days 3 and 7.
The total symptom score (sum of eye pain, photophobia, blurred
vision, foreign body sensation and lacrimation scores) and total
sign score (sum of anterior chamber cell, anterior chamber flare,
ciliary hyperemia, keratic precipitate and synechia of iris and
posterior scores) were compared between baseline and Days 3, 7
and 14.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shigeaki Ono principal investigator
Department of Ophthalmology and Visual Science, Graduate School of Medicine, Hokkaido University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Difluprednate Ophthalmic Emulsion in people with Uveitis and Panuveitis, run by Sirion Therapeutics, Inc..
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 5 inclusion and 11 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 4 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The anterior chamber cell score was compared between baseline and Day 14.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Dec 2006.