Trial Outcomes & Findings for Safety and Efficacy of Difluprednate 0.05% for the Treatment of Anterior Uveitis (NCT NCT01201798)

NCT ID: NCT01201798

Last Updated: 2012-11-15

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 111 participants
• Primary outcome timeframe: Baseline (Day 0), Day 14
• Results posted on: 2012-11-15

Participant Flow

Subjects were recruited from 21 US study sites.

This reporting group includes all randomized subjects: 110. One subject was enrolled but discontinued prior to receiving study medication, with treatment randomization unknown.

Participant milestones

Measure	Durezol Difluprednate 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 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 Study STARTED	56	54
Overall Study COMPLETED	47	39
Overall Study NOT COMPLETED	9	15

Reasons for withdrawal

Measure	Durezol Difluprednate 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 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 Study Adverse Event	2	0
Overall Study Lost to Follow-up	3	5
Overall Study Decision Unrelated to an Adverse Event	1	1
Overall Study Noncompliance	1	0
Overall Study Protocol Violation	1	1
Overall Study Treatment Failure	1	8

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Durezol n=56 Participants Difluprednate 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 n=54 Participants 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 n=110 Participants Total of all reporting groups
Age Continuous	49.8 years STANDARD_DEVIATION 15.20 • n=5 Participants	45.5 years STANDARD_DEVIATION 18.29 • n=7 Participants	47.7 years STANDARD_DEVIATION 16.85 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	29 Participants n=7 Participants	60 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 0), Day 14

Population: 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.

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.

Outcome measures

Measure	Durezol n=46 Participants Difluprednate 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 n=47 Participants 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
Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14 Baseline (Day 0)	2.6 Units on a scale Standard Deviation 0.68	2.6 Units on a scale Standard Deviation 0.68
Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14 Day 14	-2.2 Units on a scale Standard Deviation 0.96 • Interval -0.53 to 0.09	-2.0 Units on a scale Standard Deviation 1.00

SECONDARY outcome

Timeframe: Baseline (Day 0), Day 3, Day 7, Day 21, Day 28, Day 35, Day 42

Population: 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.

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.

Outcome measures

Measure	Durezol n=46 Participants Difluprednate 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 n=47 Participants 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
Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14 Baseline (Day 0)	2.6 Units on a scale Standard Deviation 0.68	2.6 Units on a scale Standard Deviation 0.68
Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14 Day 3	-1.1 Units on a scale Standard Deviation 0.95	-1.0 Units on a scale Standard Deviation 0.86
Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14 Day 7	-1.8 Units on a scale Standard Deviation 0.77	-1.6 Units on a scale Standard Deviation 0.85
Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14 Day 21	-2.4 Units on a scale Standard Deviation 0.98	-2.1 Units on a scale Standard Deviation 0.80
Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14 Day 28	-2.3 Units on a scale Standard Deviation 0.95	-2.1 Units on a scale Standard Deviation 0.95
Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14 Day 35	-2.3 Units on a scale Standard Deviation 0.94	-2.1 Units on a scale Standard Deviation 1.04
Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14 Day 42	-2.3 Units on a scale Standard Deviation 1.00	-2.1 Units on a scale Standard Deviation 1.01

SECONDARY outcome

Timeframe: Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

Population: 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.

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.

Outcome measures

Measure	Durezol n=46 Participants Difluprednate 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 n=47 Participants 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
Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points Day 21	-2.0 Units on a scale Standard Deviation 0.77	-2.0 Units on a scale Standard Deviation 0.78
Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points Day 28	-2.0 Units on a scale Standard Deviation 0.76	-2.0 Units on a scale Standard Deviation 0.79
Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points Baseline (Day 0)	2.2 Units on a scale Standard Deviation 0.48	2.3 Units on a scale Standard Deviation 0.54
Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points Day 3	-1.1 Units on a scale Standard Deviation 0.83	-1.2 Units on a scale Standard Deviation 1.07
Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points Day 7	-1.6 Units on a scale Standard Deviation 0.77	-1.6 Units on a scale Standard Deviation 0.95
Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points Day 14	-2.0 Units on a scale Standard Deviation 0.75	-1.9 Units on a scale Standard Deviation 0.91
Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points Day 35	-2.0 Units on a scale Standard Deviation 0.77	-2.0 Units on a scale Standard Deviation 0.83
Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points Day 42	-2.0 Units on a scale Standard Deviation 0.77	-2.0 Units on a scale Standard Deviation 0.82

SECONDARY outcome

Timeframe: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

Population: 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.

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.

Outcome measures

Measure	Durezol n=46 Participants Difluprednate 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 n=47 Participants 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
Proportion of Subjects With Anterior Chamber Cell Grade of 0 Day 28	80.4 Percentage of subjects	70.2 Percentage of subjects
Proportion of Subjects With Anterior Chamber Cell Grade of 0 Day 35	78.3 Percentage of subjects	70.2 Percentage of subjects
Proportion of Subjects With Anterior Chamber Cell Grade of 0 Day 42	76.1 Percentage of subjects	74.5 Percentage of subjects
Proportion of Subjects With Anterior Chamber Cell Grade of 0 Day 3	15.2 Percentage of subjects	6.4 Percentage of subjects
Proportion of Subjects With Anterior Chamber Cell Grade of 0 Day 7	34.8 Percentage of subjects	25.5 Percentage of subjects
Proportion of Subjects With Anterior Chamber Cell Grade of 0 Day 14	65.2 Percentage of subjects	55.3 Percentage of subjects
Proportion of Subjects With Anterior Chamber Cell Grade of 0 Day 21	84.8 Percentage of subjects	63.8 Percentage of subjects

SECONDARY outcome

Timeframe: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

Population: 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.

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.

Outcome measures

Measure	Durezol n=46 Participants Difluprednate 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 n=47 Participants 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
Proportion of Subjects With Anterior Chamber Cell Count of 0 Day 3	13.0 Percentage of subjects	2.1 Percentage of subjects
Proportion of Subjects With Anterior Chamber Cell Count of 0 Day 7	21.7 Percentage of subjects	21.3 Percentage of subjects
Proportion of Subjects With Anterior Chamber Cell Count of 0 Day 14	52.2 Percentage of subjects	38.3 Percentage of subjects
Proportion of Subjects With Anterior Chamber Cell Count of 0 Day 21	73.9 Percentage of subjects	48.9 Percentage of subjects
Proportion of Subjects With Anterior Chamber Cell Count of 0 Day 28	73.9 Percentage of subjects	63.8 Percentage of subjects
Proportion of Subjects With Anterior Chamber Cell Count of 0 Day 35	69.6 Percentage of subjects	63.8 Percentage of subjects
Proportion of Subjects With Anterior Chamber Cell Count of 0 Day 42	69.6 Percentage of subjects	68.1 Percentage of subjects

SECONDARY outcome

Timeframe: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

Population: 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.

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.

Outcome measures

Measure	Durezol n=46 Participants Difluprednate 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 n=47 Participants 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
Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0 Day 3	13.0 Percentage of subjects	14.9 Percentage of subjects
Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0 Day 14	78.3 Percentage of subjects	61.7 Percentage of subjects
Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0 Day 21	82.6 Percentage of subjects	76.6 Percentage of subjects
Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0 Day 7	41.3 Percentage of subjects	40.4 Percentage of subjects
Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0 Day 28	80.4 Percentage of subjects	76.6 Percentage of subjects
Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0 Day 35	82.6 Percentage of subjects	76.6 Percentage of subjects
Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0 Day 42	80.4 Percentage of subjects	78.7 Percentage of subjects

SECONDARY outcome

Timeframe: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

Population: 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.

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.

Outcome measures

Measure	Durezol n=46 Participants Difluprednate 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 n=47 Participants 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
Proportion of Subjects With Anterior Chamber Cell Grade ≤1 Day 28	93.5 Percentage of subjects	87.2 Percentage of subjects
Proportion of Subjects With Anterior Chamber Cell Grade ≤1 Day 35	93.5 Percentage of subjects	85.1 Percentage of subjects
Proportion of Subjects With Anterior Chamber Cell Grade ≤1 Day 42	91.3 Percentage of subjects	85.1 Percentage of subjects
Proportion of Subjects With Anterior Chamber Cell Grade ≤1 Day 14	93.5 Percentage of subjects	85.1 Percentage of subjects
Proportion of Subjects With Anterior Chamber Cell Grade ≤1 Day 3	50.0 Percentage of subjects	57.4 Percentage of subjects
Proportion of Subjects With Anterior Chamber Cell Grade ≤1 Day 7	87.0 Percentage of subjects	80.9 Percentage of subjects
Proportion of Subjects With Anterior Chamber Cell Grade ≤1 Day 21	93.5 Percentage of subjects	89.4 Percentage of subjects

SECONDARY outcome

Timeframe: Time to Event

Population: 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.

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.

Outcome measures

Measure	Durezol n=46 Participants Difluprednate 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 n=47 Participants 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
Proportion of Subjects Who Discontinued Due to Lack of Efficacy	0 Percentage of subjects	14.9 Percentage of subjects

SECONDARY outcome

Timeframe: Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

Population: 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.

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.

Outcome measures

Measure	Durezol n=46 Participants Difluprednate 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 n=47 Participants 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
Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points Day 3	-88.4 Units on a scale Standard Deviation 92.55	-88.4 Units on a scale Standard Deviation 92.71
Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points Day 14	-133.3 Units on a scale Standard Deviation 109.3	-137.4 Units on a scale Standard Deviation 108.8
Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points Day 35	-143.9 Units on a scale Standard Deviation 111.0	-147.3 Units on a scale Standard Deviation 111.3
Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points Baseline (Day 0)	186.7 Units on a scale Standard Deviation 112.6	203.2 Units on a scale Standard Deviation 110.8
Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points Day 7	-108.2 Units on a scale Standard Deviation 114.2	-123.8 Units on a scale Standard Deviation 100.4
Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points Day 21	-138.8 Units on a scale Standard Deviation 112.7	-149.5 Units on a scale Standard Deviation 108.0
Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points Day 28	-140.1 Units on a scale Standard Deviation 111.4	-152.4 Units on a scale Standard Deviation 115.9
Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points Day 42	-146.2 Units on a scale Standard Deviation 111.7	-155.5 Units on a scale Standard Deviation 112.1

SECONDARY outcome

Timeframe: Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

Population: 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.

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.

Outcome measures

Measure	Durezol n=46 Participants Difluprednate 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 n=47 Participants 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
Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits Day 3	-3.5 Units on a scale Standard Deviation 2.71	-3.6 Units on a scale Standard Deviation 2.95
Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits Day 7	-5.2 Units on a scale Standard Deviation 2.31	-5.0 Units on a scale Standard Deviation 3.05
Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits Day 14	-6.1 Units on a scale Standard Deviation 2.81	-5.8 Units on a scale Standard Deviation 3.34
Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits Day 21	-6.5 Units on a scale Standard Deviation 3.07	-6.2 Units on a scale Standard Deviation 3.04
Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits Day 28	-6.4 Units on a scale Standard Deviation 2.96	-6.2 Units on a scale Standard Deviation 3.18
Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits Day 42	-6.2 Units on a scale Standard Deviation 3.21	-6.3 Units on a scale Standard Deviation 3.27
Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits Baseline (Day 0)	7.1 Units on a scale Standard Deviation 2.71	7.3 Units on a scale Standard Deviation 2.87
Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits Day 35	-6.3 Units on a scale Standard Deviation 2.98	-6.2 Units on a scale Standard Deviation 3.34

Adverse Events

Durezol

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Pred Forte

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Durezol n=56 participants at risk Difluprednate 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 n=54 participants at risk 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
Eye disorders Necrotising retinitis	1.8% 1/56 • 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 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.	0.00% 0/54 • 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 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.
Vascular disorders Hypertension	1.8% 1/56 • 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 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.	0.00% 0/54 • 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 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.

Other adverse events

Measure	Durezol n=56 participants at risk Difluprednate 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 n=54 participants at risk 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
Eye disorders Iridocyclitis	5.4% 3/56 • 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 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.	3.7% 2/54 • 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 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.
Eye disorders Punctate keratitis	5.4% 3/56 • 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 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.	0.00% 0/54 • 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 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.
Investigations Intraocular Pressure Increased	8.9% 5/56 • 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 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.	3.7% 2/54 • 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 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.
Nervous system disorders Headache	5.4% 3/56 • 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 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.	7.4% 4/54 • 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 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.

Additional Information

Head, Alcon Clinical

Alcon Research, Ltd.

Phone: 1-888-451-3937

Email: medinfo@alconlabs.com

Results disclosure agreements

• Principal investigator is a sponsor employee Alcon reserves the right of prior review of any publication or presentation of information related to the study.
• Publication restrictions are in place

Restriction type: OTHER