Trial · NCT01201798
Safety and Efficacy of Difluprednate 0.05% for the Treatment of Anterior Uveitis
NCT01201798, Phase 3, Completed, Alcon Research; results first posted 2012-11-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of Difluprednate 0.05% for the Treatment of Anterior Uveitis. Trials, record NCT01201798. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01201798
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Difluprednate 0.05% for the Treatment of Anterior Uveitis
- NCT number
- NCT01201798
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 111 participants, actual
- Lead sponsor
- Alcon Research
- Conditions
- Endogenous Anterior Uveitis
- Interventions
- Difluprednate 0.05% ophthalmic emulsion, Prednisolone acetate 1.0% ophthalmic suspension
- First posted
- 2010-09-15
- Last updated
- 2012-11-15
- Results first posted
- 2012-11-15
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14 | 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. |
| Secondary | Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14 | Baseline (Day 0), Day 3, Day 7, Day 21, Day 28, Day 35, Day 42 | 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. |
| Secondary | Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points | Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42 | 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. |
| Secondary | Proportion of Subjects With Anterior Chamber Cell Grade of 0 | Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42 | 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. |
| Secondary | Proportion of Subjects With Anterior Chamber Cell Count of 0 | Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42 | 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. |
| Secondary | Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0 | Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42 | 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. |
| Secondary | Proportion of Subjects With Anterior Chamber Cell Grade ≤1 | Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42 | 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. |
| Secondary | Proportion of Subjects Who Discontinued Due to Lack of Efficacy | Time to Event | 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. |
| Secondary | Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points | Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42 | 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. |
| Secondary | Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits | Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42 | 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14 | Baseline (Day 0), Day 14 | 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. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14 | Baseline (Day 0), Day 3, Day 7, Day 21, Day 28, Day 35, Day 42 | 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. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points | Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42 | 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. | Units on a scale | MEAN |
| SECONDARY | Proportion of Subjects With Anterior Chamber Cell Grade of 0 | Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42 | 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. | Percentage of subjects | NUMBER |
| SECONDARY | Proportion of Subjects With Anterior Chamber Cell Count of 0 | Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42 | 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. | Percentage of subjects | NUMBER |
| SECONDARY | Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0 | Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42 | 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. | Percentage of subjects | NUMBER |
| SECONDARY | Proportion of Subjects With Anterior Chamber Cell Grade ≤1 | Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42 | 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. | Percentage of subjects | NUMBER |
| SECONDARY | Proportion of Subjects Who Discontinued Due to Lack of Efficacy | Time to Event | 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. | Percentage of subjects | NUMBER |
| SECONDARY | Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points | Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42 | 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. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits | Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42 | 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. | Units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group124
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14 | Durezol | Baseline (Day 0) | 2.6 | Standard Deviation 0.68 | Units on a scale |
| Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14 | Pred Forte | Baseline (Day 0) | 2.6 | Standard Deviation 0.68 | Units on a scale |
| Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14 | Durezol | Day 14 | -2.2 | Standard Deviation 0.96 | Units on a scale |
| Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14 | Pred Forte | Day 14 | -2.0 | Standard Deviation 1.00 | Units on a scale |
| Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14 | Durezol | Baseline (Day 0) | 2.6 | Standard Deviation 0.68 | Units on a scale |
| Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14 | Pred Forte | Baseline (Day 0) | 2.6 | Standard Deviation 0.68 | Units on a scale |
| Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14 | Durezol | Day 3 | -1.1 | Standard Deviation 0.95 | Units on a scale |
| Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14 | Pred Forte | Day 3 | -1.0 | Standard Deviation 0.86 | Units on a scale |
| Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14 | Durezol | Day 7 | -1.8 | Standard Deviation 0.77 | Units on a scale |
| Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14 | Pred Forte | Day 7 | -1.6 | Standard Deviation 0.85 | Units on a scale |
1 to 10 of 124Source ClinicalTrials.gov
See all 124 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Durezol | 56 | |
| Overall Study | STARTED | Pred Forte | 54 | |
| Overall Study | COMPLETED | Durezol | 47 | |
| Overall Study | COMPLETED | Pred Forte | 39 | |
| Overall Study | NOT COMPLETED | Durezol | 9 | |
| Overall Study | NOT COMPLETED | Pred Forte | 15 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Iridocyclitis | Eye disorders | Durezol | 3 | 56 | |
| other | Iridocyclitis | Eye disorders | Pred Forte | 2 | 54 | |
| other | Punctate keratitis | Eye disorders | Durezol | 3 | 56 | |
| other | Punctate keratitis | Eye disorders | Pred Forte | 0 | 54 | |
| other | Intraocular Pressure Increased | Investigations | Durezol | 5 | 56 | |
| other | Intraocular Pressure Increased | Investigations | Pred Forte | 2 | 54 | |
| other | Headache | Nervous system disorders | Durezol | 3 | 56 | |
| other | Headache | Nervous system disorders | Pred Forte | 4 | 54 | |
| serious | Necrotising retinitis | Eye disorders | Durezol | 1 | 56 | |
| serious | Necrotising retinitis | Eye disorders | Pred Forte | 0 | 54 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Durezol | ||
| Total, all-cause mortality | Pred Forte | ||
| Total, other adverse events | Durezol | 14 | 56 |
| Total, other adverse events | Pred Forte | 8 | 54 |
| Total, serious adverse events | Durezol | 2 | 56 |
| Total, serious adverse events | Pred Forte | 0 | 54 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24677110 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Durezol vs Pred Forte: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01201798
GET https://conductscience.org/api/trials/v1/NCT01201798/results?page=2