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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01201798
Recruitment Status : Completed
First Posted : September 15, 2010
Results First Posted : November 15, 2012
Last Update Posted : November 15, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Endogenous Anterior Uveitis
Interventions Drug: Difluprednate 0.05% ophthalmic emulsion
Drug: Prednisolone acetate 1.0% ophthalmic suspension
Enrollment 111
Recruitment Details Subjects were recruited from 21 US study sites.
Pre-assignment Details This reporting group includes all randomized subjects: 110. One subject was enrolled but discontinued prior to receiving study medication, with treatment randomization unknown.
Arm/Group Title Durezol Pred Forte
Hide Arm/Group Description Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period 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
Period Title: Overall Study
Started 56 54
Completed 47 39
Not Completed 9 15
Reason Not Completed
Adverse Event             2             0
Lost to Follow-up             3             5
Decision Unrelated to an Adverse Event             1             1
Noncompliance             1             0
Protocol Violation             1             1
Treatment Failure             1             8
Arm/Group Title Durezol Pred Forte Total
Hide Arm/Group Description Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period 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 Total of all reporting groups
Overall Number of Baseline Participants 56 54 110
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 56 participants 54 participants 110 participants
49.8  (15.20) 45.5  (18.29) 47.7  (16.85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 54 participants 110 participants
Female
31
  55.4%
29
  53.7%
60
  54.5%
Male
25
  44.6%
25
  46.3%
50
  45.5%
1.Primary Outcome
Title Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14
Hide Description 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.
Time Frame Baseline (Day 0), Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Durezol Pred Forte
Hide Arm/Group Description:
Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
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
Overall Number of Participants Analyzed 46 47
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (Day 0) 2.6  (0.68) 2.6  (0.68)
Day 14 -2.2  (0.96) -2.0  (1.00)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Durezol, Pred Forte
Comments A two-tailed 95% confidence interval was calculated for the difference in change from baseline in anterior chamber cell grade at Day 14 (difluprednate minus prednisolone). The confidence interval was derived from an analysis of covariance (ANCOVA), with investigative site included as a fixed effect to match the stratification used in the randomization process. Treatment and baseline anterior chamber cell grade were also included as fixed effects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The noninferiority margin was 0.5 units, meaning that the upper limit of the two-tailed 95% confidence interval must have been less than 0.5 to establish noninferiority.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.22
Confidence Interval (2-Sided) 95%
-0.53 to 0.09
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14
Hide Description 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.
Time Frame Baseline (Day 0), Day 3, Day 7, Day 21, Day 28, Day 35, Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Durezol Pred Forte
Hide Arm/Group Description:
Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
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
Overall Number of Participants Analyzed 46 47
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (Day 0) 2.6  (0.68) 2.6  (0.68)
Day 3 -1.1  (0.95) -1.0  (0.86)
Day 7 -1.8  (0.77) -1.6  (0.85)
Day 21 -2.4  (0.98) -2.1  (0.80)
Day 28 -2.3  (0.95) -2.1  (0.95)
Day 35 -2.3  (0.94) -2.1  (1.04)
Day 42 -2.3  (1.00) -2.1  (1.01)
3.Secondary Outcome
Title Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points
Hide Description 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.
Time Frame Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Durezol Pred Forte
Hide Arm/Group Description:
Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
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
Overall Number of Participants Analyzed 46 47
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (Day 0) 2.2  (0.48) 2.3  (0.54)
Day 3 -1.1  (0.83) -1.2  (1.07)
Day 7 -1.6  (0.77) -1.6  (0.95)
Day 14 -2.0  (0.75) -1.9  (0.91)
Day 21 -2.0  (0.77) -2.0  (0.78)
Day 28 -2.0  (0.76) -2.0  (0.79)
Day 35 -2.0  (0.77) -2.0  (0.83)
Day 42 -2.0  (0.77) -2.0  (0.82)
4.Secondary Outcome
Title Proportion of Subjects With Anterior Chamber Cell Grade of 0
Hide Description 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.
Time Frame Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Durezol Pred Forte
Hide Arm/Group Description:
Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
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
Overall Number of Participants Analyzed 46 47
Measure Type: Number
Unit of Measure: Percentage of subjects
Day 3 15.2 6.4
Day 7 34.8 25.5
Day 14 65.2 55.3
Day 21 84.8 63.8
Day 28 80.4 70.2
Day 35 78.3 70.2
Day 42 76.1 74.5
5.Secondary Outcome
Title Proportion of Subjects With Anterior Chamber Cell Count of 0
Hide Description 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.
Time Frame Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Durezol Pred Forte
Hide Arm/Group Description:
Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
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
Overall Number of Participants Analyzed 46 47
Measure Type: Number
Unit of Measure: Percentage of subjects
Day 3 13.0 2.1
Day 7 21.7 21.3
Day 14 52.2 38.3
Day 21 73.9 48.9
Day 28 73.9 63.8
Day 35 69.6 63.8
Day 42 69.6 68.1
6.Secondary Outcome
Title Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0
Hide Description 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.
Time Frame Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Durezol Pred Forte
Hide Arm/Group Description:
Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
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
Overall Number of Participants Analyzed 46 47
Measure Type: Number
Unit of Measure: Percentage of subjects
Day 3 13.0 14.9
Day 7 41.3 40.4
Day 14 78.3 61.7
Day 21 82.6 76.6
Day 28 80.4 76.6
Day 35 82.6 76.6
Day 42 80.4 78.7
7.Secondary Outcome
Title Proportion of Subjects With Anterior Chamber Cell Grade ≤1
Hide Description 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.
Time Frame Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Durezol Pred Forte
Hide Arm/Group Description:
Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
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
Overall Number of Participants Analyzed 46 47
Measure Type: Number
Unit of Measure: Percentage of subjects
Day 3 50.0 57.4
Day 7 87.0 80.9
Day 14 93.5 85.1
Day 21 93.5 89.4
Day 28 93.5 87.2
Day 35 93.5 85.1
Day 42 91.3 85.1
8.Secondary Outcome
Title Proportion of Subjects Who Discontinued Due to Lack of Efficacy
Hide Description 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.
Time Frame Time to Event
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Durezol Pred Forte
Hide Arm/Group Description:
Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
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
Overall Number of Participants Analyzed 46 47
Measure Type: Number
Unit of Measure: Percentage of subjects
0 14.9
9.Secondary Outcome
Title Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points
Hide Description 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.
Time Frame Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Durezol Pred Forte
Hide Arm/Group Description:
Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
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
Overall Number of Participants Analyzed 46 47
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (Day 0) 186.7  (112.6) 203.2  (110.8)
Day 3 -88.4  (92.55) -88.4  (92.71)
Day 7 -108.2  (114.2) -123.8  (100.4)
Day 14 -133.3  (109.3) -137.4  (108.8)
Day 21 -138.8  (112.7) -149.5  (108.0)
Day 28 -140.1  (111.4) -152.4  (115.9)
Day 35 -143.9  (111.0) -147.3  (111.3)
Day 42 -146.2  (111.7) -155.5  (112.1)
10.Secondary Outcome
Title Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits
Hide Description 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.
Time Frame Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Durezol Pred Forte
Hide Arm/Group Description:
Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
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
Overall Number of Participants Analyzed 46 47
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (Day 0) 7.1  (2.71) 7.3  (2.87)
Day 3 -3.5  (2.71) -3.6  (2.95)
Day 7 -5.2  (2.31) -5.0  (3.05)
Day 14 -6.1  (2.81) -5.8  (3.34)
Day 21 -6.5  (3.07) -6.2  (3.04)
Day 28 -6.4  (2.96) -6.2  (3.18)
Day 35 -6.3  (2.98) -6.2  (3.34)
Day 42 -6.2  (3.21) -6.3  (3.27)
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.
Adverse Event Reporting Description Adverse events were obtained as solicited comments from study subjects and observations by study investigator as outlined in study protocol. An adverse event was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship.
 
Arm/Group Title Durezol Pred Forte
Hide Arm/Group Description Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period 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
All-Cause Mortality
Durezol Pred Forte
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Durezol Pred Forte
Affected / at Risk (%) Affected / at Risk (%)
Total   2/56 (3.57%)   0/54 (0.00%) 
Eye disorders     
Necrotising retinitis  1 [1]  1/56 (1.79%)  0/54 (0.00%) 
Vascular disorders     
Hypertension  1 [2]  1/56 (1.79%)  0/54 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
[1]
Non-related
[2]
Not related
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Durezol Pred Forte
Affected / at Risk (%) Affected / at Risk (%)
Total   14/56 (25.00%)   8/54 (14.81%) 
Eye disorders     
Iridocyclitis  1  3/56 (5.36%)  2/54 (3.70%) 
Punctate keratitis  1  3/56 (5.36%)  0/54 (0.00%) 
Investigations     
Intraocular Pressure Increased  1  5/56 (8.93%)  2/54 (3.70%) 
Nervous system disorders     
Headache  1  3/56 (5.36%)  4/54 (7.41%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Alcon reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Head, Alcon Clinical
Organization: Alcon Research, Ltd.
Phone: 1-888-451-3937
EMail: medinfo@alconlabs.com
Layout table for additonal information
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01201798    
Other Study ID Numbers: C-10-034
First Submitted: September 13, 2010
First Posted: September 15, 2010
Results First Submitted: August 31, 2012
Results First Posted: November 15, 2012
Last Update Posted: November 15, 2012