Endogenous Anterior UveitisPhase 3NCT01201798

Safety and Efficacy of Difluprednate 0.05% for the Treatment of Anterior Uveitis

A Phase 3 study testing Difluprednate 0.05% ophthalmic emulsion and Prednisolone acetate 1.0% ophthalmic suspension in people with Endogenous Anterior Uveitis, run by Alcon Research at 1 site in United States.

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 study was to demonstrate that difluprednate 0.05% (Durezol) dosed 4 times daily is noninferior to prednisolone 1% (Pred Forte) dosed 8 times daily for the treatment of endogenous anterior uveitis. Read more about this study

Who is it for?: Ages 2 years and older
Conditions the study is for: Endogenous Anterior Uveitis
What is being tested?: Difluprednate 0.05% ophthalmic emulsion and Prednisolone acetate 1.0% ophthalmic suspension
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 111 participants
Where: 1 siteUnited States
Study dates: Oct 2010to Aug 2011
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
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Diagnosis of endogenous anterior uveitis in at least 1 eye.
The presence of > 10 cells in the anterior chamber of at least one eye, and a flare score of > 2 in that same eye.
Age 2 years or older on day of consent.
Negative urine pregnancy test on Day 0 for females of childbearing potential who are not at least 1 year post-menopausal or surgically sterilized.
Other protocol-defined inclusion criteria may apply.

Who cannot join

Presence of endogenous anterior uveitis diagnosed for > 2 weeks prior to enrollment in the study.
Presence of intermediate uveitis, posterior uveitis or panuveitis in either eye.
Instillation of any topical corticosteroid or NSAID in the study eye within 7 days of instillation of study drug.
History of glaucoma or clinically significant ocular hypertension in the opinion of the Investigator involving an IOP ≥ 21 millimeters mercury in either eye.
History of steroid-induced elevation of intraocular pressure.
Any confirmed or suspected active viral, bacterial or fungal keratoconjunctival disease in either eye.

Show all 10Show fewer

History of glaucoma or clinically significant ocular hypertension in the opinion of the Investigator involving an intraocular pressure (IOP) > 21 mmHg in either eye.
Corneal abrasion or ulceration in either eye.
Pregnancy or lactation.
Other protocol-defined exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

United States1 site

Contact Alcon Call Center
Fort Worth, Texas, 76134

Other trials in United States

About this study

Official title: A Phase 3 Multicenter, Randomized, Double-Masked Study of the Safety and Efficacy of Difluprednate 0.05% Ophthalmic Emulsion Compared to Prednisolone Acetate 1% Ophthalmic Suspension in the Treatment of Endogenous Anterior Uveitis

Conditions: Endogenous Anterior Uveitis
Being tested: Difluprednate 0.05% ophthalmic emulsion, Prednisolone acetate 1.0% ophthalmic suspension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Difluprednate 0.05% ophthalmic emulsionDrug
Also called Durezol
1 drop in study eye, 4 times a day, for 14 days, followed by a 14-day tapering period dependent on the Investigator's determination of adequate response to treatment
Prednisolone acetate 1.0% ophthalmic suspensionDrug
Also called Pred Forte
1 drop in study eye, 8 times a day, for 14 days, followed by a 14-day tapering period dependent on the Investigator's determination of adequate response to treatment

Study groups in NCT01201798
Study group	Role	What they receive
Durezol	Experimental	Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period Receives: Drug: Difluprednate 0.05% ophthalmic emulsion
Pred Forte	Active comparator	Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period Receives: Drug: Prednisolone acetate 1.0% ophthalmic suspension

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14
Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = > 50 cell count.
Measured: Baseline (Day 0), Day 14

Secondary outcomes (9)

Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14
Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = > 50 cell count.
Measured: Baseline (Day 0), Day 3, Day 7, Day 21, Day 28, Day 35, Day 42
Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points
Anterior chamber flare (protein escaping from dialated vessels) was assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = none; 1 = mild (trace to clearly noticeable, visible); 2 = moderate; 3 = marked; and 4 = severe.
Measured: Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42
Proportion of Subjects With Anterior Chamber Cell Grade of 0
Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = > 50 cell count. Proportion is reported as percentage of subjects.
Measured: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42
Proportion of Subjects With Anterior Chamber Cell Count of 0
Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and recorded based on actual cell count. Proportion is reported as a percentage of subjects.
Measured: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42
Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0
Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and recorded based on actual cell count. Anterior chamber flare (protein escaping from dialated vessels) was assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = none; 1 = mild (trace to clearly noticeable, visible); 2 = moderate; 3 = marked; and 4 = severe. Proportion is reported as percentage of subjects.
Measured: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42
Proportion of Subjects With Anterior Chamber Cell Grade ≤1
As assessed by the investigator during slit lamp examination. Anterior chamber cell grade was graded on a 5-point scale, with 0 = no cells; 1 = 1 to 10 cells; 2 = 11 to 20 cells; 3 = 21 to 50 cells; and 4 = more than 50 cells. Proportion is reported as percentage of subjects.
Measured: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42
Proportion of Subjects Who Discontinued Due to Lack of Efficacy
Lack of efficacy was defined as those subjects who discontinued study participation either due to treatment failure or an adverse event with a preferred term of iridocyclitis, iritis, uveitis, or vitritis. Proportion is reported as percentage of subjects.
Measured: Time to Event
Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points
The following symptoms were each graded by the subject according to a 0-100 visual analog scale (VAS) using a mark on a 100 mm line (0 = absent, 100 = maximal): eye pain, photophobia, blurred vision, and lacrimation. The total symptom score was calculated as the sum of the 4 individual symptom scores.
Measured: Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42
Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits
The following signs were each graded on a 0 - 3 scale (0 = absent; 1 = mild; 2 = moderate; 3 = severe): posterior synechia, hypopyon, limbal injection, and keratic precipitates. Peripheral synechia was graded by the combined number of clock hours affected (0 = absent; 1 = < 3 hrs; 2 = 3-6 hours; 3 = > 6 hours). The total sign score was calculated as the sum of the 5 individual sign scores, the anterior chamber cell grade and the anterior chamber flare grade. The minimum/best total sign score was 0, and the maximum/worst total sign score was 23.
Measured: Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

Timeline

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

Oct 2010Aug 2011

First posted15 Sep 2010 (estimated)
Study startOct 2010
Primary completionAug 2011
Study completionAug 2011

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 Endogenous Anterior UveitisStudies of the same condition, open and under way.
More trials run by Alcon ResearchThe sponsor's other registered studies.
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: 111 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01201798
Sponsor's protocol ID: C-10-034
Status last verified: Oct 2012
First submitted: 13 Sep 2010
Last updated: 15 Nov 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Sheppard JD, Toyos MM, Kempen JH, Kaur P, Foster CS. Difluprednate 0.05% versus prednisolone acetate 1% for endogenous anterior uveitis: a phase III, multicenter, randomized study. Invest Ophthalmol Vis Sci. 2014 May 6;55(5):2993-3002. doi: 10.1167/iovs.13-12660.
PubMed 24677110

Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3 Multicenter, Randomized, Double-Masked Study of the Safety and Efficacy of Difluprednate 0.05% Ophthalmic Emulsion Compared to Prednisolone Acetate 1% Ophthalmic Suspension in the Treatment of Endogenous Anterior Uveitis
ClinicalTrials.gov ID: NCT01201798
Acronym / sponsor ID: C-10-034
Conditions: Endogenous Anterior Uveitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 111 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: Aug 2011 (actual)
Study completion: Aug 2011 (actual)
First posted: 15 Sep 2010 (estimated)
Results: Posted 15 Nov 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Durezol	Experimental	Drug: Difluprednate 0.05% ophthalmic emulsionDifluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
Pred Forte	Active comparator	Drug: Prednisolone acetate 1.0% ophthalmic suspensionPrednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period

Who may qualify

Ages: 2 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

Diagnosis of endogenous anterior uveitis in at least 1 eye.
The presence of > 10 cells in the anterior chamber of at least one eye, and a flare score of > 2 in that same eye.
Age 2 years or older on day of consent.
Negative urine pregnancy test on Day 0 for females of childbearing potential who are not at least 1 year post-menopausal or surgically sterilized.
Other protocol-defined inclusion criteria may apply.

Key exclusion criteria (10 listed)

Presence of endogenous anterior uveitis diagnosed for > 2 weeks prior to enrollment in the study.
Presence of intermediate uveitis, posterior uveitis or panuveitis in either eye.
Instillation of any topical corticosteroid or NSAID in the study eye within 7 days of instillation of study drug.
History of glaucoma or clinically significant ocular hypertension in the opinion of the Investigator involving an IOP ≥ 21 millimeters mercury in either eye.
History of steroid-induced elevation of intraocular pressure.

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 0.05% ophthalmic emulsionAlso: Durezol1 drop in study eye, 4 times a day, for 14 days, followed by a 14-day tapering period dependent on the Investigator's determination of adequate response to treatment	Drug	Durezol
Prednisolone acetate 1.0% ophthalmic suspensionAlso: Pred Forte1 drop in study eye, 8 times a day, for 14 days, followed by a 14-day tapering period dependent on the Investigator's determination of adequate response to treatment	Drug	Pred Forte

Primary outcome

Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14
Time frame: Baseline (Day 0), Day 14
Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = > 50 cell count.

9 secondary outcomes

Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14
Time frame: Baseline (Day 0), Day 3, Day 7, Day 21, Day 28, Day 35, Day 42
Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points
Time frame: Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42
Proportion of Subjects With Anterior Chamber Cell Grade of 0
Time frame: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42
Proportion of Subjects With Anterior Chamber Cell Count of 0
Time frame: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42
Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0
Time frame: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42
Proportion of Subjects With Anterior Chamber Cell Grade ≤1
Time frame: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42
Proportion of Subjects Who Discontinued Due to Lack of Efficacy
Time frame: Time to Event
Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points
Time frame: Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42
Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits
Time frame: Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

Results and safety

Results posted to the registry on 15 Nov 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Durezol	56	47
Pred Forte	54	39

Primary outcome: Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14

Time frame: Baseline (Day 0), Day 14. Mean (Standard Deviation). Unit: Units on a scale

Measure	Durezol n = 46	Pred Forte n = 47
Baseline (Day 0)	2.6 (0.68)	2.6 (0.68)
Day 14	-2.2 (0.96)	-2.0 (1.00)

Durezol vs Pred Forte: Mean Difference (Net): -0.22 (95% CI -0.53 to 0.09), ANCOVA

Population analysed: Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected for the duration of the study: 9 months, 3 weeks. The safety population consisted of all randomized subjects who received at least 1 dose of the allocated study medication.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Durezol	2 of 56 (3.6%)	14 of 56 (25%)	Not reported
Pred Forte	0 of 54 (0%)	8 of 54 (14.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24677110Sheppard JD, Toyos MM, Kempen JH, Kaur P, Foster CS. Difluprednate 0.05% versus prednisolone acetate 1% for endogenous anterior uveitis: a phase III, multicenter, randomized study. Invest Ophthalmol Vis Sci. 2014 May 6;55(5):2993-3002. doi: 10.1167/iovs.13-12660.

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 10 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 15 Nov 2012. 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. 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 15 Nov 2012). 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?

Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14 (time frame: Baseline (Day 0), Day 14). 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 NCT01201798, 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 15 Nov 2012.