InflammationPhase 2NCT00407225
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 12 to 75 years
- 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
- Dec 1999to Oct 2000
- 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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with a mean postoperative (on the day of surgery or the day after surgery) flare intensity of 30 photon counts/msec
- Male and female patients aged 12 and <75 years who were able to accurately express their own symptoms
- Patients providing written informed consent prior to the start of the study
- Inpatients (patients were allowed to be discharged from the hospital during the study period)
Who cannot join
- Patients who did not meet any of the above inclusion criteria
- Patients receiving systemic administration, or topical application to the head or face (including instillation to the eyes) of any steroid, nonsteroidal anti-inflammatory drug, antiphlogistic enzyme, immunosuppressive drug or colchicine within 1 week prior to the start of the study treatment
- Patients with glaucoma or ocular hypertension (IOP: 21 mmHg)
- Patients with corneal abrasion or ulcer
- Patients with any viral keratoconjunctival disease, tuberculosus eye disease, fungal eye disease or bacterial eye disease
- Patients with diabetes who met any of the following criteria
Show all 16Show fewer
- HbA1C was 9.0% within 1 month prior to obtaining informed consent.
- Proliferative diabetic retinopathy was present.
- Rubeosis iridis was present.
- Patients with allergy to steroids
- Patients requiring the use of contact lens during the study period
- Women who were or might be pregnant
- Patients participating in another clinical study within 6 months prior to the start of the present study
- Patients sensitive to steroids (patients who previously experienced increased IOP after instillation of a steroid)
- Patients with a Grade 5 nuclear hardness as diagnosed according to Emery-Little classification
- Patients with fibrins or posterior rupture at baseline (F0)
About this study
Official title: Phase 2a Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation After Cataract Surgery
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 the efficacy and safety of 0.002% and 0.05% difluprednate ophthalmic emulsions in patients with postoperative inflammation after cataract surgery (implantation of intraocular lens). In addition, the evaluation system for a future dose-finding phase III study of difluprednate ophthalmic emulsion will be established.
- 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 flare intensity on Day 72 (F7) was compared with the baseline flare intensity (F0).
The ratios of the flare intensity on Day 1 (F1), that on Day 31 (F3) and that on Day 72 (F7) to
the baseline flare intensity (F0) (F1/F0, F3/F0 and F7/F0, respectively) were determined. Each
ratio was compared between the 0.002% and 0.05% difluprednate groups to identify when the
between-group difference in the effect of difluprednate became significant.
Secondary outcomes (7)
The total score of anterior chamber signs (cells and protein) on Day 72 (S7) was compared
with the baseline total score (S0).
As the secondary efficacy evaluation, the ratios of the total score of anterior chamber signs
(cells and protein) on Day 1 (S1), that on Day 31 (S3) and that on Day 72 (S7) to the baseline
total score (S0) (S1/S0, S3/S0 and S7/S0, respectively) were determined. Each ratio was
compared between the 0.002% and 0.05% difluprednate groups to identify when the
between-group difference in the effect of difluprednate became significant.
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 startDec 1999
- Study completionOct 2000
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
- Kanjiro Masuda, Study chair, Director, Kanto Rosai Hospital; Director, Japanese Red Cross Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00407225
- Sponsor's protocol ID
- SJE2079/2-01-PC
- Status last verified
- Nov 2006
- First submitted
- 29 Nov 2006
- Last updated
- 6 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 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 After Cataract Surgery
- ClinicalTrials.gov ID
- NCT00407225
- Acronym / sponsor ID
- SJE2079/2-01-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
- Dec 1999
- Study completion
- Oct 2000
- 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 the efficacy and safety of 0.002% and 0.05% difluprednate ophthalmic emulsions in patients with postoperative inflammation after cataract surgery (implantation of intraocular lens). In addition, the evaluation system for a future dose-finding phase III study of difluprednate ophthalmic emulsion will be established.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a mean postoperative (on the day of surgery or the day after surgery) flare intensity of 30 photon counts/msec
- Male and female patients aged 12 and <75 years who were able to accurately express their own symptoms
- Patients providing written informed consent prior to the start of the study
- Inpatients (patients were allowed to be discharged from the hospital during the study period)
Key exclusion criteria (16 listed)
- Patients who did not meet any of the above inclusion criteria
- Patients receiving systemic administration, or topical application to the head or face (including instillation to the eyes) of any steroid, nonsteroidal anti-inflammatory drug, antiphlogistic enzyme, immunosuppressive drug or colchicine within 1 week prior to the start of the study treatment
- Patients with glaucoma or ocular hypertension (IOP: 21 mmHg)
- Patients with corneal abrasion or ulcer
- Patients with any viral keratoconjunctival disease, tuberculosus eye disease, fungal eye disease or bacterial eye disease
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 flare intensity on Day 72 (F7) was compared with the baseline flare intensity (F0).
The ratios of the flare intensity on Day 1 (F1), that on Day 31 (F3) and that on Day 72 (F7) to
the baseline flare intensity (F0) (F1/F0, F3/F0 and F7/F0, respectively) were determined. Each
ratio was compared between the 0.002% and 0.05% difluprednate groups to identify when the
between-group difference in the effect of difluprednate became significant.
7 secondary outcomes
The total score of anterior chamber signs (cells and protein) on Day 72 (S7) was compared
with the baseline total score (S0).
As the secondary efficacy evaluation, the ratios of the total score of anterior chamber signs
(cells and protein) on Day 1 (S1), that on Day 31 (S3) and that on Day 72 (S7) to the baseline
total score (S0) (S1/S0, S3/S0 and S7/S0, respectively) were determined. Each ratio was
compared between the 0.002% and 0.05% difluprednate groups to identify when the
between-group difference in the effect of difluprednate became significant.
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 6 Dec 2006.
Related trials for Inflammation
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
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.
Kanjiro Masuda study chair
Director, Kanto Rosai Hospital; Director, Japanese Red Cross Medical Center
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 16 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 6 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 flare intensity on Day 72 (F7) was compared with the baseline flare intensity (F0).. The study lists 5 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 6 Dec 2006.