InflammationPhase 3NCT00429923
Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601A-002a)
A Phase 3 study testing Difluprednate in people with Inflammation, run by Sirion Therapeutics, Inc. at 1 site in United States.
Trial summary
The purpose of this phase III study is to determine the efficacy of difluprednate in the treatment of inflammation following ocular surgery. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Inflammation
- What is being tested?
- Difluprednate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 219 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Unilateral ocular surgery in the day prior to study enrollment.
- Anterior chamber cell grade ≥ "2" on the day after surgery (Day 1).
- Aged 2 years or older on the day of consent.
- Negative urine pregnancy test on Day 1 for postmenarchal subjects; negative urine pregnancy test for premenarchal subjects at the investigator's discretion.
- Provide signed written consent prior to entering the study or signed written consent from parent or legal guardian if subject is a minor and signed assent from minor subject, if appropriate.
- Presurgical Exclusion Criteria:
Show all 25Show fewer
- Systemic administration of any corticosteroid in the 2 weeks prior to study enrollment.
- Periocular injection in the study eye of any corticosteroid solution within 4 weeks prior to instillation of the study drug, or of any corticosteroid depot within 2 months prior to instillation of the study drug.
- Instillation of any topical ocular corticosteroid or NSAID within 24 hours prior to instillation of the study drug or during the course of the study, with the exception of presurgical administration of a topical NSAID to prevent miosis.
- Any history of glaucoma or ocular hypertension in the study eye.
- History or presence of endogenous uveitis.
- Any current corneal abrasion or ulceration.
- Any confirmed or suspected active viral, bacterial, or fungal keratoconjunctival disease.
- Allergy to similar drugs, such as other corticosteroids.
- History of steroid-related IOP increase.
- Scheduled surgery on the contralateral eye during the treatment period.
- Unwilling to discontinue use of contact lenses during the study period.
- Pregnancy or lactation.
- Participation in any study of an investigational topical or systemic new drug or device within 30 days prior to screening, or at any time during the study.
- Prior participation in the study described in this protocol.
- Unable or unwilling to give signed informed consent prior to participation in any study related procedures.
- Postsurgical Exclusion Criteria:
- Ocular hemorrhage which interferes with evaluation of postsurgery inflammation.
- Injection of gas into the vitreous body during surgery.
- Presence of IOP ≥24 mm Hg on Day 1 after surgery.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3 Multicenter, Randomized, Double-Masked, Placebo-Controlled Study of the Safety and Efficacy of Difluprednate in the Treatment of Inflammation Following Ocular Surgery
The purpose of this phase III study is to determine the efficacy of difluprednate in the treatment of inflammation following ocular surgery.
- Conditions
- Inflammation
- Being tested
- Difluprednate, Placebo
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DifluprednateDrug
DifluprednateDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Difluprednate 0.05% BID | Experimental | Difluprednate 0.05% 1 drop BID for 14 days. Receives: Drug: Difluprednate |
| Difluprednate 0.05% QID | Experimental | Difluprednate 0.05% 1 drop QID for 14 days. Receives: Drug: Difluprednate |
| Placebo | Placebo comparator | Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior Chamber Cell Grade of "0" on Day 8 (Difluprednate QID vs Placebo).
Measured on a 0 to 4 scale: "0" is ≤ 1 cell; "1" is 2-10 cells; "2" is 11-20 cells; "3" is 21-50 cells; "4" is > 50 cells.
Measured: Day 8 (QID)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Who is masked
- Participant, Investigator
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sirion Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Roger Vogel, MD, Study chair, Sirion Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00429923
- Sponsor's protocol ID
- ST-601A-002a
- Status last verified
- May 2009
- First submitted
- 31 Jan 2007
- Last updated
- 2 Jul 2009
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Korenfeld MS, Silverstein SM, Cooke DL, Vogel R, Crockett RS; Difluprednate Ophthalmic Emulsion 0.05% (Durezol) Study Group. Difluprednate ophthalmic emulsion 0.05% for postoperative inflammation and pain. J Cataract Refract Surg. 2009 Jan;35(1):26-34. doi: 10.1016/j.jcrs.2008.09.024.
PubMed 19101421
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Multicenter, Randomized, Double-Masked, Placebo-Controlled Study of the Safety and Efficacy of Difluprednate in the Treatment of Inflammation Following Ocular Surgery
- ClinicalTrials.gov ID
- NCT00429923
- Acronym / sponsor ID
- ST-601A-002a
- Conditions
- Inflammation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Sirion Therapeutics, Inc.Industry (pharma, biotech, devices)
- First posted
- 1 Feb 2007 (estimated)
- Results
- Posted 2 Jul 2009
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 III study is to determine the efficacy of difluprednate in the treatment of inflammation following ocular surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Difluprednate 0.05% BID | Experimental | Drug: DifluprednateDifluprednate 0.05% 1 drop BID for 14 days. |
| Difluprednate 0.05% QID | Experimental | Drug: DifluprednateDifluprednate 0.05% 1 drop QID for 14 days. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (25 listed)
- Unilateral ocular surgery in the day prior to study enrollment.
- Anterior chamber cell grade ≥ "2" on the day after surgery (Day 1).
- Aged 2 years or older on the day of consent.
- Negative urine pregnancy test on Day 1 for postmenarchal subjects; negative urine pregnancy test for premenarchal subjects at the investigator's discretion.
- Provide signed written consent prior to entering the study or signed written consent from parent or legal guardian if subject is a minor and signed assent from minor subject, if appropriate.
Key exclusion criteria (0 listed)
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 | Drug | Difluprednate 0.05% BID |
| Difluprednate | Drug | Difluprednate 0.05% QID |
| Placebo | Drug | Placebo |
Primary outcome
Anterior Chamber Cell Grade of "0" on Day 8 (Difluprednate QID vs Placebo).
Time frame: Day 8 (QID)
Measured on a 0 to 4 scale: "0" is ≤ 1 cell; "1" is 2-10 cells; "2" is 11-20 cells; "3" is 21-50 cells; "4" is > 50 cells.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 19101421Korenfeld MS, Silverstein SM, Cooke DL, Vogel R, Crockett RS; Difluprednate Ophthalmic Emulsion 0.05% (Durezol) Study Group. Difluprednate ophthalmic emulsion 0.05% for postoperative inflammation and pain. J Cataract Refract Surg. 2009 Jan;35(1):26-34. doi: 10.1016/j.jcrs.2008.09.024.
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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.
Roger Vogel, MD study chair
Sirion Therapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Difluprednate in people with Inflammation, run by Sirion Therapeutics, Inc. at 1 site in United States.
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 25 inclusion and 0 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 2 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 2 Jul 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Anterior Chamber Cell Grade of "0" on Day 8 (Difluprednate QID vs Placebo). (time frame: Day 8 (QID)). 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 NCT00429923, which also lists 1 linked publication.
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 2 Jul 2009.