InflammationPhase 3NCT00406341

Study of Difluprednate Ophthalmic Emulsion in Postoperative Inflammation

A Phase 3 study testing Difluprednate Ophthalmic Emulsion in people with Inflammation, run by Sirion Therapeutics, Inc..

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 phase 3 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: 200 participants
Where: No sites listed yet
Study dates: Apr 2004to Mar 2005
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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients who have undergone cataract surgery, vitreous surgery or both (including patients who have undergone IOL insertion surgery at the same time)
Patients showing an anterior chamber cell score of not less than "2" at a day after surgery
Patients aged 20 years or over, irrespective of genders (it is eligible for enrollment when patients' age attains the criterion on the day of consent obtainment)

Who cannot join

Patients who took systemic administration of corticosteroids or immunosuppressive agents, or used ophthalmic ointments of corticosteroids within 1 week before instillation of the investigational drugs;
Patients who underwent local injection of corticosteroids in the eyes before instillation of the investigational drugs; (patients who used aqueous preparations within 1 week or patient who used depot preparations within 2 weeks were excluded)
Patients who took systemic administration of non-steroidal antiinflammatory agents or antiinflammatory enzyme preparations within 3 days before instillation of the investigational drugs;
Patients who instilled of corticosteroids, no-steroidal antiinflammatory agents or antiinflammatory enzyme preparations within 24 hours before the pre-instillation observation (a day after surgery);
Patients who underwent perioperative and/or postoperative intravitreous injection of corticosteroids;
Patients who underwent sub-conjunctival injection or sub-Tenon capsule injection of corticosteroids;

Show all 18Show fewer

Patients who have intraocular hemorrhage with a degree that may affect the postoperative evaluations;
Patients who underwent gas tamponade at the surgery;
Patients with endogenous uveitis;
Patients having corneal epithelial detachment or corneal ulcer in the target eye;
Patients who are suspected of having viral, bacterial or mycotic keratoconjunctival disorders in the target or opposite eye;
Patients with glaucoma or ocular hypertension, or those with past history of IOP increased due to instillation of corticosteroids, or those whose IOP has been controlled by use of ophthalmic antihypertensive agents;
Patients showing IOP not less than 25 mmHg a day after surgery;
Patients who have allergy to corticosteroid drugs;
Patients who are required to wear contact lens during the study period;
Patients who are scheduled to undergo surgery of the opposite eye during the study period;
Patients who are pregnant or may be pregnant or lactating;
Patients who have participated in other clinical studies within 3 months.

About this study

Official title: Phase 3 Confimatory Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treament of Postoperative Inflammation

The purpose of this phase 3 study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of postoperative inflammation.

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 intraocular postoperative 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 changes in anterior chamber cell score at day 14 after start of instillation from the baseline level (differences from the baseline score) were compared between the 2 treatment groups.

Secondary outcomes (4)

The changes in anterior chamber cell score at days 3 and 7 after start of instillation were compared between the 2 treatment groups.
The numbers of patients showing an anterior chamber cell score of "0" at days 3, 7 and 14 after start of instillation were compared between the 2 treatment groups.
The changes in anterior chamber flare score at days 3, 7 and 14 after start of instillation (difference from the baseline score) were compared between the 2 treatment groups.
The changes in the total scores of subjective symptoms and objective signs at days 3, 7 and 14 after start of instillation (difference from the baseline score) were compared between the 2 treatment groups.

Timeline

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

Apr 2004Mar 2005

First posted4 Dec 2006 (estimated)
Study startApr 2004
Study completionMar 2005

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 200 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00406341
Sponsor's protocol ID: SJE2079/3-03
Status last verified: Nov 2006
First submitted: 29 Nov 2006
Last updated: 4 Dec 2006
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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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 Confimatory Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treament of Postoperative Inflammation
ClinicalTrials.gov ID: NCT00406341
Acronym / sponsor ID: SJE2079/3-03
Conditions: Inflammation
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants
Lead sponsor: Sirion Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: Apr 2004
Study completion: Mar 2005
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 study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of postoperative inflammation.

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 intraocular postoperative 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 (3 listed)

Patients who have undergone cataract surgery, vitreous surgery or both (including patients who have undergone IOL insertion surgery at the same time)
Patients showing an anterior chamber cell score of not less than "2" at a day after surgery
Patients aged 20 years or over, irrespective of genders (it is eligible for enrollment when patients' age attains the criterion on the day of consent obtainment)

Key exclusion criteria (18 listed)

Patients who took systemic administration of corticosteroids or immunosuppressive agents, or used ophthalmic ointments of corticosteroids within 1 week before instillation of the investigational drugs;
Patients who underwent local injection of corticosteroids in the eyes before instillation of the investigational drugs; (patients who used aqueous preparations within 1 week or patient who used depot preparations within 2 weeks were excluded)
Patients who took systemic administration of non-steroidal antiinflammatory agents or antiinflammatory enzyme preparations within 3 days before instillation of the investigational drugs;
Patients who instilled of corticosteroids, no-steroidal antiinflammatory agents or antiinflammatory enzyme preparations within 24 hours before the pre-instillation observation (a day after surgery);
Patients who underwent perioperative and/or postoperative intravitreous injection of corticosteroids;

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 changes in anterior chamber cell score at day 14 after start of instillation from the baseline level (differences from the baseline score) were compared between the 2 treatment groups.

4 secondary outcomes

The changes in anterior chamber cell score at days 3 and 7 after start of instillation were compared between the 2 treatment groups.
The numbers of patients showing an anterior chamber cell score of "0" at days 3, 7 and 14 after start of instillation were compared between the 2 treatment groups.
The changes in anterior chamber flare score at days 3, 7 and 14 after start of instillation (difference from the baseline score) were compared between the 2 treatment groups.
The changes in the total scores of subjective symptoms and objective signs at days 3, 7 and 14 after start of instillation (difference from the baseline score) were compared between the 2 treatment 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 study chair

Department of Ophthalmology and Visual Sciences, 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 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 3 inclusion and 18 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 changes in anterior chamber cell score at day 14 after start of instillation from the baseline level (differences from the baseline score) were compared between the 2 treatment groups.. 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 NCT00406341.

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.