Anterior UveitisPhase 3NCT00406887
Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis
A Phase 3 study testing Difluprednate Ophthalmic Emulsion in people with Anterior Uveitis and Panuveitis, run by Sirion Therapeutics, Inc..
Trial summary
The purpose of this phase 3 confirmatory study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of treatment of uveitis. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Anterior Uveitis, Panuveitis
- What is being tested?
- Difluprednate Ophthalmic Emulsion
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Aug 2002to Nov 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 diagnosed with endogenous anterior uveitis or panuveitis
- Patients with 10 - 49 anterior chamber cells within one field of the anterior chamber as observed by slit lamp microscopy (criterion for rating of signs 2 or 3)
- Patients aged ‰1425 years (on the day of obtaining informed consent) who were able to accurately express their own symptoms
- Patients provided written informed consent prior to initiation of the study
Who cannot join
- Patients who did not meet all of the above inclusion criteria
- Patients received systemic administration of any corticosteroid or immunosuppressive drug within the past 1 week prior to instillation of the investigational product
- Patients received topical injection of any corticosteroid in eyes prior to instillation of the investigational product (Solution formulation: within the past 1 week, depot: within the past 2 weeks)
- Patients received systemic administration of any non-steroidal anti-inflammatory drug or antiphlogistic enzyme within the past 3 days prior to instillation of the investigational product
- Patients received instillation of any corticosteroid, non-steroidal anti-inflammatory drug or antiphlogistic enzyme within 12 hours prior to instillation of the investigational product
- Patients with glaucoma or ocular hypertension
Show all 12Show fewer
- Patients with corneal abrasion or ulcer
- Patients with any confirmed or suspected viral, bacterial or fungal keratoconjunctival disease
- Patients with allergy to similar drugs such as other corticosteroids
- Patients requiring use of contact lens during the study period
- Women who are or might be pregnant, or lactating women
- Patients participating in another clinical study within the past 3 months before initiation of the present study
About this study
Official title: Phase 3 Confirmatory Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Anterior Uveitis (Including Panuveitis).
The purpose of this phase 3 confirmatory study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of treatment of 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 (DFBA) in patients with endogenous anterior uveitis, in comparison with 0.1% betamethasone sodium phosphate ophthalmic solution (BP).
- Conditions
- Anterior Uveitis, Panuveitis
- Being tested
- Difluprednate Ophthalmic Emulsion
- Medical subject headings
- Uveitis, Anterior, 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 difference from the baseline in anterior chamber cell score on Day 14
was compared between the two groups.
Secondary outcomes (8)
The differences from the baseline in anterior chamber cell score on Days 3 and 7
were compared between the two groups.
The numbers of patients with an anterior chamber cell score of 0 on Days 7 and
14 were compared between the two groups.
The differences from the baseline in total sign and symptom scores on Days 3, 7
and 14 were compared between the two groups.
The numbers of patients with an anterior chamber cell score of 1 or less on Days
3, 7 and 14 were compared between the two groups.
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 completionNov 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 140 participants
Sponsor and investigators
- Lead sponsor
- Sirion Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Shigeaki Ohno, PhD, Principal investigator, Department of Ophthalmology and Visual Science, Graduate School of Medicine, Hokkaido University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00406887
- Sponsor's protocol ID
- SJE2079/3-01-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 Confirmatory Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Anterior Uveitis (Including Panuveitis).
- ClinicalTrials.gov ID
- NCT00406887
- Acronym / sponsor ID
- SJE2079/3-01-PC
- Conditions
- Anterior Uveitis, Panuveitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants
- Lead sponsor
- Sirion Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2002
- Study completion
- Nov 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 confirmatory study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of treatment of uveitis.
Detailed description
The objective of this phase 3 study is to assess the efficacy and safety of 0.05% difluprednate ophthalmic emulsion (DFBA) in patients with endogenous anterior uveitis, in comparison with 0.1% betamethasone sodium phosphate ophthalmic solution (BP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with endogenous anterior uveitis or panuveitis
- Patients with 10 - 49 anterior chamber cells within one field of the anterior chamber as observed by slit lamp microscopy (criterion for rating of signs 2 or 3)
- Patients aged ‰1425 years (on the day of obtaining informed consent) who were able to accurately express their own symptoms
- Patients provided written informed consent prior to initiation of the study
Key exclusion criteria (12 listed)
- Patients who did not meet all of the above inclusion criteria
- Patients received systemic administration of any corticosteroid or immunosuppressive drug within the past 1 week prior to instillation of the investigational product
- Patients received topical injection of any corticosteroid in eyes prior to instillation of the investigational product (Solution formulation: within the past 1 week, depot: within the past 2 weeks)
- Patients received systemic administration of any non-steroidal anti-inflammatory drug or antiphlogistic enzyme within the past 3 days prior to instillation of the investigational product
- Patients received instillation of any corticosteroid, non-steroidal anti-inflammatory drug or antiphlogistic enzyme within 12 hours prior to instillation of the investigational product
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 difference from the baseline in anterior chamber cell score on Day 14
was compared between the two groups.
8 secondary outcomes
The differences from the baseline in anterior chamber cell score on Days 3 and 7
were compared between the two groups.
The numbers of patients with an anterior chamber cell score of 0 on Days 7 and
14 were compared between the two groups.
The differences from the baseline in total sign and symptom scores on Days 3, 7
and 14 were compared between the two groups.
The numbers of patients with an anterior chamber cell score of 1 or less on Days
3, 7 and 14 were compared between the two groups.
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 Ohno, PhD 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 Anterior 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 4 inclusion and 12 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 difference from the baseline in anterior chamber cell score on Day 14. The study lists 2 primary outcomes in all. 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.