A Phase 3 interventional study of Difluprednate Ophthalmic Emulsion in Anterior Uveitis and Panuveitis, sponsored by Sirion Therapeutics, Inc.. Completed. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2006-12-04.
Sponsored by Sirion Therapeutics, Inc. · Phase 3, Interventional, and Treatment
The purpose of this phase 3 confirmatory study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of treatment of uveitis.
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).
56 studies on the registry are indexed under Uveitis, Anterior; 9 are open to participants now.
This study's enrollment of 140 is above the median of 50 across 45 interventional studies indexed under Uveitis, Anterior.
Browse Uveitis, Anterior studies →Sirion Therapeutics, Inc. is the lead sponsor of 15 studies on the registry; none are open to participants now.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The difference from the baseline in anterior chamber cell score on Day 14
was compared between the two groups.
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.
No study locations are listed for this record.
This study is completed, as verified in Nov 2006. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Difluprednate
Sirion Therapeutics, Inc.