InflammationPhase 2NCT00406497
Study of Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation
A Phase 2 study testing Difluprednate Ophthalmic Emulsion in people with Inflammation, run by Sirion Therapeutics, Inc..
Trial summary
The purpose of this phase 2 study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of postoperative inflammation. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Inflammation
- What is being tested?
- Difluprednate Ophthalmic Emulsion
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Apr 2003to Jul 2003
- Phase
- Phase 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing intraocular surgery (cataract surgery, cataract surgery + implantation of intraocular lens, vitreous surgery, cataract surgery + implantation of intraocular lens + vitreous surgery)
- Patients with anterior chamber cell score ≥2 on the next day of surgery
- Male and female patients aged ≥20 years (on the day of obtaining informed consent)
- 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 receiving systemic administration of any corticosteroid or immunosuppressive drug, or topical application of corticosteroid ophthalmic ointment within 1 week before instillation of the investigational product
- Patients receiving topical injection of any corticosteroid in eyes before instillation of the investigational product (aqueous preparation: within 1 week before instillation of the investigational product, depot preparation: within 2 weeks before instillation of the investigational product)
- Patients receiving systemic administration of any non-steroidal anti-inflammatory drug or antiphlogistic enzyme
- Patients receiving instillation of any corticosteroid, non-steroidal anti-inflammatory ophthalmic solution or antiphologistic enzyme within 24 hours before ophthalmic examination prior to instillation of the investigational product (on the next day of surgery) (except instillation of non-steroidal anti-inflammatory ophthalmic solution at 3, 2, 1 and 0.5 hours before surgery)
- Patients with endogenous uveitis
Show all 17Show fewer
- Patients planning to undergo surgery of the contralateral eye during the study period
- Patients with new intraocular bleeding after surgery
- Patients receiving gas or silicon oil in the vitreous body
- Patients with glaucoma or ocular hypertension (IOP on the next day of surgery ≥25 mmHg)
- Patients with superficial punctuate keratopathy or corneal ulcer
- Patients with any viral, bacterial or fungal keratoconjunctival disease
- Patients with allergy to any corticosteroid
- 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
- Patients undergoing surgery under systemic anesthesia
About this study
Official title: Phase 2a Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation
The purpose of this phase 2 study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of postoperative inflammation.
Read the detailed description
The objective is to assess efficacy endpoints in comparison with 0.1% BM ophthalmic solution, prior to investigation of the efficacy and safety of 0.05% DFBA ophthalmic emulsion in the treatment of postoperative intraocular inflammation.
- Conditions
- Inflammation
- Being tested
- Difluprednate Ophthalmic Emulsion
- Medical subject headings
- Inflammation
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 variation from baseline in anterior chamber cell score on Day 14 (difference from baseline
score) was compared between the test and control groups.
Secondary outcomes (6)
The variations from baseline in anterior chamber cell score on Days 3 and 7 were compared
between the test and control groups.
The numbers of patients with an anterior chamber cell score of 0 on Days 7 and 14 were
compared between the test and control groups.
The variations from baseline in anterior chamber flare score on Days 3, 7 and 14 were
The variations from baseline in total sign and symptom scores on Days 3, 7 and 14 were
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 startApr 2003
- Study completionJul 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- Sirion Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Shigeaki Ohno, Study chair, Professor, Department of Ophthalmology and Visual Science, Graduate School of Medicine, Hokkaido University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00406497
- Sponsor's protocol ID
- SJE2079/2-03-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 2a Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation
- ClinicalTrials.gov ID
- NCT00406497
- Acronym / sponsor ID
- SJE2079/2-03-PC
- Conditions
- Inflammation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- Sirion Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2003
- Study completion
- Jul 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 2 study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of postoperative inflammation.
Detailed description
The objective is to assess efficacy endpoints in comparison with 0.1% BM ophthalmic solution, prior to investigation of the efficacy and safety of 0.05% DFBA ophthalmic emulsion in the treatment of postoperative intraocular inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing intraocular surgery (cataract surgery, cataract surgery + implantation of intraocular lens, vitreous surgery, cataract surgery + implantation of intraocular lens + vitreous surgery)
- Patients with anterior chamber cell score ≥2 on the next day of surgery
- Male and female patients aged ≥20 years (on the day of obtaining informed consent)
- Patients giving written informed consent prior to initiation of the study
Key exclusion criteria (17 listed)
- Patients who did not meet all of the above inclusion criteria
- Patients receiving systemic administration of any corticosteroid or immunosuppressive drug, or topical application of corticosteroid ophthalmic ointment within 1 week before instillation of the investigational product
- Patients receiving topical injection of any corticosteroid in eyes before instillation of the investigational product (aqueous preparation: within 1 week before instillation of the investigational product, depot preparation: within 2 weeks before instillation of the investigational product)
- Patients receiving systemic administration of any non-steroidal anti-inflammatory drug or antiphlogistic enzyme
- Patients receiving instillation of any corticosteroid, non-steroidal anti-inflammatory ophthalmic solution or antiphologistic enzyme within 24 hours before ophthalmic examination prior to instillation of the investigational product (on the next day of surgery) (except instillation of non-steroidal anti-inflammatory ophthalmic solution at 3, 2, 1 and 0.5 hours before surgery)
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 variation from baseline in anterior chamber cell score on Day 14 (difference from baseline
score) was compared between the test and control groups.
6 secondary outcomes
The variations from baseline in anterior chamber cell score on Days 3 and 7 were compared
between the test and control groups.
The numbers of patients with an anterior chamber cell score of 0 on Days 7 and 14 were
compared between the test and control groups.
The variations from baseline in anterior chamber flare score on Days 3, 7 and 14 were
The variations from baseline in total sign and symptom scores on Days 3, 7 and 14 were
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 study chair
Professor, Department of Ophthalmology and Visual Science, Graduate School of Medicine, Hokkaido University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Difluprednate Ophthalmic Emulsion in people with Inflammation, 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 17 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 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?
The variation from baseline in anterior chamber cell score on Day 14 (difference from baseline. 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.