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Trial record 11 of 52 for:    cataract AND ophthalmic suspension

Difluprednate Pediatric Study for the Treatment of Inflammation Post-Cataract Surgery

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: NCT01124045
Recruitment Status : Completed
First Posted : May 14, 2010
Results First Posted : June 19, 2013
Last Update Posted : June 19, 2013
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
Conditions Cataracts
Inflammation
Interventions Drug: Difluprednate ophthalmic emulsion, 0.05%
Drug: Prednisolone acetate ophthalmic suspension, 1.0%
Enrollment 80
Recruitment Details Patients were screened and recruited from 17 study centers located within the United States.
Pre-assignment Details This reporting group includes all patients who were exposed to the study drug. One patient randomized to DUREZOL withdrew consent prior to receiving study medication.
Arm/Group Title DUREZOL PRED FORTE
Hide Arm/Group Description Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
Period Title: Overall Study
Started 39 40
Completed 39 37
Not Completed 0 3
Reason Not Completed
Lost to Follow-up             0             1
Physician Decision             0             2
Arm/Group Title DUREZOL PRED FORTE Total
Hide Arm/Group Description Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment Total of all reporting groups
Overall Number of Baseline Participants 39 40 79
Hide Baseline Analysis Population Description
Baseline characteristics are presented for all patients who were exposed to the study drug.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 39 participants 40 participants 79 participants
Newborns: 0 to 27 days 3 3 6
Infants and Toddlers: 28 days to 23 months 28 26 54
Children: 2 to 3 years 8 11 19
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 40 participants 79 participants
Female
22
  56.4%
20
  50.0%
42
  53.2%
Male
17
  43.6%
20
  50.0%
37
  46.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 39 participants 40 participants 79 participants
39 40 79
1.Primary Outcome
Title Percentage of Patients With an Anterior Cell Grade of 0 (no Cells) at Day 15 ± 2 Days
Hide Description Anterior cell grade was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 5-point scale: Grade 0=0 cells; Grade 1=1 to 10 cells; Grade 2=11 to 20 cells; Grade 3=21 to 50 cells; Grade 4=>50 cells. The presence of blood cells (red and white) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation.
Time Frame Day 15 ± 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT): All patients who received at least 1 dose of study medication. One patient (DUREZOL) had missing anterior cell grade assessment at all visits.
Arm/Group Title DUREZOL PRED FORTE
Hide Arm/Group Description:
Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
Overall Number of Participants Analyzed 38 40
Measure Type: Number
Unit of Measure: Percentage of patients
78.9 77.5
2.Secondary Outcome
Title Global Assessment Score of Postoperative Inflammation by Visit
Hide Description A Global Assessment Score (GAS) was assigned by the Investigator based on the clinical evidence of postoperative inflammation: 0=clear, 1=improving satisfactorily; 2=not improving or worsening, withdrawal from study indicated to allow appropriate alternative therapy to be instituted. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.
Time Frame Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.
Arm/Group Title DUREZOL PRED FORTE
Hide Arm/Group Description:
Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
Overall Number of Participants Analyzed 39 40
Measure Type: Number
Unit of Measure: Percentage of patients
Day 1: Grade 0 30.8 17.5
Day 1: Grade 1 69.2 82.5
Day 1: Grade 2 0.0 0.0
Day 8: Grade 0 48.7 25.0
Day 8: Grade 1 48.7 70.0
Day 8: Grade 2 2.6 5.0
Day 15: Grade 0 56.4 50.0
Day 15: Grade 1 43.6 50.0
Day 15: Grade 2 0.0 0.0
Day 29: Grade 0 79.5 72.5
Day 29: Grade 1 20.5 25.0
Day 29: Grade 2 0.0 2.5
1 Week after Last Dose: Grade 0 89.7 90.0
1 Week after Last Dose: Grade 1 7.7 7.5
1 Week after Last Dose: Grade 2 2.6 2.5
Month 3: Grade 0 92.3 92.5
Month 3: Grade 1 5.1 7.5
Month 3: Grade 2 2.6 0.0
3.Secondary Outcome
Title Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade
Hide Description Anterior chamber cell grade was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 5-point scale: Grade 0=0 cells; Grade 1=1 to 10 cells; Grade 2=11 to 20 cells; Grade 3=21 to 50 cells; Grade 4=>50 cells. The presence of blood cells (red and white) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.
Time Frame Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT): All patients who received at least 1 dose of study medication. One patient had missing anterior cell grade assessment at all visits.
Arm/Group Title DUREZOL PRED FORTE
Hide Arm/Group Description:
Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
Overall Number of Participants Analyzed 38 40
Measure Type: Number
Unit of Measure: Percentage of patients
Day 1: Grade 0 23.7 40.0
Day 1: Grade 1 57.9 30.0
Day 1: Grade 2 15.8 27.5
Day 1: Grade 3 2.6 0.0
Day 1: Grade 4 0.0 2.5
Day 8: Grade 0 55.3 57.5
Day 8: Grade 1 36.8 32.5
Day 8: Grade 2 5.3 10.0
Day 8: Grade 3 2.6 0.0
Day 8: Grade 4 0.0 0.0
Day 15: Grade 0 78.9 77.5
Day 15: Grade 1 18.4 17.5
Day 15: Grade 2 0.0 5.0
Day 15: Grade 3 2.6 0.0
Day 15: Grade 4 0.0 0.0
Day 29: Grade 0 89.5 95.0
Day 29: Grade 1 10.5 2.5
Day 29: Grade 2 0.0 2.5
Day 29: Grade 3 0.0 0.0
Day 29: Grade 4 0.0 0.0
1 Week after Last Dose: Grade 0 97.4 95.0
1 Week after Last Dose: Grade 1 2.6 2.5
1 Week after Last Dose: Grade 2 0.0 2.5
1 Week after Last Dose: Grade 3 0.0 0.0
1 Week After Last Dose: Grade 4 0.0 0.0
Month 3: Grade 0 94.7 97.5
Month 3: Grade 1 5.3 0.0
Month 3: Grade 2 0.0 2.5
Month 3: Grade 3 0.0 0.0
Month 3: Grade 4 0.0 0.0
4.Secondary Outcome
Title Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade
Hide Description Anterior chamber flare was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. The presence of flare (increased protein levels) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.
Time Frame Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.
Arm/Group Title DUREZOL PRED FORTE
Hide Arm/Group Description:
Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
Overall Number of Participants Analyzed 38 40
Measure Type: Number
Unit of Measure: Percentage of patients
Day 1: Grade 0 41.0 45.0
Day 1: Grade 1 51.3 37.5
Day 1: Grade 2 7.7 12.5
Day 1: Grade 3 0.0 5.0
Day 8: Grade 0 61.5 52.5
Day 8: Grade 1 35.9 40.0
Day 8: Grade 2 2.6 5.0
Day 8: Grade 3 0.0 2.5
Day 15: Grade 0 74.4 70.0
Day 15: Grade 1 17.9 27.5
Day 15: Grade 2 7.7 2.5
Day 15: Grade 3 0.0 0.0
Day 29: Grade 0 87.2 92.5
Day 29: Grade 1 12.8 7.5
Day 29: Grade 2 0.0 0.0
Day 29: Grade 3 0.0 0.0
1 Week after Last Dose: Grade 0 94.9 92.5
1 Week after Last Dose: Grade 1 2.6 7.5
1 Week after Last Dose: Grade 2 2.6 0.0
1 Week after Last Dose: Grade 3 0.0 0.0
Month 3: Grade 0 92.3 95.0
Month 3: Grade 1 5.1 5.0
Month 3: Grade 2 2.6 0.0
Month 3: Grade 3 0.0 0.0
5.Secondary Outcome
Title Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity
Hide Description Corneal clarity was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Lack of corneal clarity (1-3) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.
Time Frame Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.
Arm/Group Title DUREZOL PRED FORTE
Hide Arm/Group Description:
Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
Overall Number of Participants Analyzed 39 40
Measure Type: Number
Unit of Measure: Percentage of patients
Day 1: Grade 0 92.3 87.5
Day 1: Grade 1 7.7 12.5
Day 1: Grade 2 0.0 0.0
Day 1: Grade 3 0.0 0.0
Day 8: Grade 0 94.9 90.0
Day 8: Grade 1 5.1 7.5
Day 8: Grade 2 0.0 2.5
Day 8: Grade 3 0.0 0.0
Day 15: Grade 0 94.9 90.0
Day 15: Grade 1 5.1 10.0
Day 15: Grade 2 0.0 0.0
Day 15: Grade 3 0.0 0.0
Day 29: Grade 0 97.4 97.5
Day 29: Grade 1 2.6 2.5
Day 29: Grade 2 0.0 0.0
Day 29: Grade 3 0.0 0.0
1 Week after Last Dose: Grade 0 100.0 97.5
1 Week after Last Dose: Grade 1 0.0 2.5
1 Week after Last Dose: Grade 2 0.0 0.0
1 Week after Last Dose: Grade 3 0.0 0.0
Month 3: Grade 0 100.0 97.5
Month 3: Grade 1 0.0 2.5
Month 3: Grade 2 0.0 0.0
Month 3: Grade 3 0.0 0.0
6.Secondary Outcome
Title Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection
Hide Description Conjunctival injection was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Conjunctival injection (redness of the white sclera of the eye) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.
Time Frame Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.
Arm/Group Title DUREZOL PRED FORTE
Hide Arm/Group Description:
Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
Overall Number of Participants Analyzed 39 40
Measure Type: Number
Unit of Measure: Percentage of patients
Day 1: Grade 0 46.2 25.0
Day 1: Grade 1 48.7 65.0
Day 1: Grade 2 2.6 10.0
Day 1: Grade 3 2.6 0.0
Day 8: Grade 0 79.5 77.5
Day 8: Grade 1 20.5 22.5
Day 8: Grade 2 0.0 0.0
Day 8: Grade 3 0.0 0.0
Day 15: Grade 0 89.7 92.5
Day 15: Grade 1 10.3 7.5
Day 15: Grade 2 0.0 0.0
Day 15: Grade 3 0.0 0.0
Day 29: Grade 0 97.4 95.0
Day 29: Grade 1 2.6 5.0
Day 29: Grade 2 0.0 0.0
Day 29: Grade 3 0.0 0.0
1 Week after Last Dose: Grade 0 100.0 100.0
1 Week after Last Dose: Grade 1 0.0 0.0
1 Week after Last Dose: Grade 2 0.0 0.0
1 Week after Last Dose: Grade 3 0.0 0.0
Month 3: Grade 0 100.0 100.0
Month 3: Grade 1 0.0 0.0
Month 3: Grade 2 0.0 0.0
Month 3: Grade 3 0.0 0.0
7.Secondary Outcome
Title Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection
Hide Description Ciliary/limbal injection was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Ciliary/limbal injection (redness of the white sclera of the eye near the limbal ring) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.
Time Frame Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.
Arm/Group Title DUREZOL PRED FORTE
Hide Arm/Group Description:
Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
Overall Number of Participants Analyzed 39 40
Measure Type: Number
Unit of Measure: Percentage of patients
Day 1: Grade 0 69.2 57.5
Day 1: Grade 1 28.2 40.0
Day 1: Grade 2 0.0 2.5
Day 1: Grade 3 2.6 0.0
Day 8: Grade 0 89.7 90.0
Day 8: Grade 1 10.3 10.0
Day 8: Grade 2 0.0 0.0
Day 8: Grade 3 0.0 0.0
Day 15: Grade 0 100.0 100.0
Day 15: Grade 1 0.0 0.0
Day 15: Grade 2 0.0 0.0
Day 15: Grade 3 0.0 0.0
Day 29: Grade 0 100.0 97.5
Day 29: Grade 1 0.0 2.5
Day 29: Grade 2 0.0 0.0
Day 29: Grade 3 0.0 0.0
1 Week after Last Dose: Grade 0 100.0 100.0
1 Week after Last Dose: Grade 1 0.0 0.0
1 Week after Last Dose: Grade 2 0.0 0.0
1 Week after Last Dose: Grade 3 0.0 0.0
Month 3: Grade 0 100.0 100.0
Month 3: Grade 1 0.0 0.0
Month 3: Grade 2 0.0 0.0
Month 3: Grade 3 0.0 0.0
8.Secondary Outcome
Title Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis
Hide Description Chemosis was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Chemosis (swelling of the conjunctiva) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.
Time Frame Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.
Arm/Group Title DUREZOL PRED FORTE
Hide Arm/Group Description:
Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
Overall Number of Participants Analyzed 39 40
Measure Type: Number
Unit of Measure: Percentage of patients
Day 1: Grade 0 82.1 85.0
Day 1: Grade 1 15.4 15.0
Day 1: Grade 2 0.0 0.0
Day 1: Grade 3 2.6 0.0
Day 8: Grade 0 97.4 100.0
Day 8: Grade 1 2.6 0.0
Day 8: Grade 2 0.0 0.0
Day 8: Grade 3 0.0 0.0
Day 15: Grade 0 100.0 97.5
Day 15: Grade 1 0.0 2.5
Day 15: Grade 2 0.0 0.0
Day 15: Grade 3 0.0 0.0
Day 29: Grade 0 100.0 100.0
Day 29: Grade 1 0.0 0.0
Day 29: Grade 2 0.0 0.0
Day 29: Grade 3 0.0 0.0
1 Week after Last Dose: Grade 0 100.0 100.0
1 Week after Last Dose: Grade 1 0.0 0.0
1 Week after Last Dose: Grade 2 0.0 0.0
1 Week after Last Dose: Grade 3 0.0 0.0
Month 3: Grade 0 100.0 100.0
Month 3: Grade 1 0.0 0.0
Month 3: Grade 2 0.0 0.0
Month 3: Grade 3 0.0 0.0
9.Secondary Outcome
Title Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon
Hide Description Hypopyon was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Hypopyon (pus in the anterior chamber of the eye) is a sign of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.
Time Frame Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.
Arm/Group Title DUREZOL PRED FORTE
Hide Arm/Group Description:
Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
Overall Number of Participants Analyzed 39 40
Measure Type: Number
Unit of Measure: Percentage of patients
Day 1: Grade 0 100.0 100.0
Day 1: Grade 1 0.0 0.0
Day 1: Grade 2 0.0 0.0
Day 1: Grade 3 0.0 0.0
Day 8: Grade 0 100.0 100.0
Day 8: Grade 1 0.0 0.0
Day 8: Grade 2 0.0 0.0
Day 8: Grade 3 0.0 0.0
Day 15: Grade 0 100.0 100.0
Day 15: Grade 1 0.0 0.0
Day 15: Grade 2 0.0 0.0
Day 15: Grade 3 0.0 0.0
Day 29: Grade 0 100.0 100.0
Day 29: Grade 1 0.0 0.0
Day 29: Grade 2 0.0 0.0
Day 29: Grade 3 0.0 0.0
1 Week after Last Dose: Grade 0 100.0 100.0
1 Week after Last Dose: Grade 1 0.0 0.0
1 Week after Last Dose: Grade 2 0.0 0.0
1 Week after Last Dose: Grade 3 0.0 0.0
Month 3: Grade 0 100.0 100.0
Month 3: Grade 1 0.0 0.0
Month 3: Grade 2 0.0 0.0
Month 3: Grade 3 0.0 0.0
10.Secondary Outcome
Title Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis
Hide Description Vitritis was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Vitritis (accumulation of inflammatory cells or exudates in the vitreous humor, the fluid that fills the middle chamber of the eye) is a sign of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.
Time Frame Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.
Arm/Group Title DUREZOL PRED FORTE
Hide Arm/Group Description:
Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
Overall Number of Participants Analyzed 39 40
Measure Type: Number
Unit of Measure: Percentage of patients
Day 1: Grade 0 100.0 97.5
Day 1: Grade 1 0.0 2.5
Day 1: Grade 2 0.0 0.0
Day 1: Grade 3 0.0 0.0
Day 8: Grade 0 100.0 97.5
Day 8: Grade 1 0.0 0.0
Day 8: Grade 2 0.0 2.5
Day 8: Grade 3 0.0 0.0
Day 15: Grade 0 100.0 97.5
Day 15: Grade 1 0.0 0.0
Day 15: Grade 2 0.0 2.5
Day 15: Grade 3 0.0 0.0
Day 29: Grade 0 100.0 97.5
Day 29: Grade 1 0.0 0.0
Day 29: Grade 2 0.0 2.5
Day 29: Grade 3 0.0 0.0
1 Week after Last Dose: Grade 0 100.0 97.5
1 Week after Last Dose: Grade 1 0.0 0.0
1 Week after Last Dose: Grade 2 0.0 2.5
1 Week after Last Dose: Grade 3 0.0 0.0
Month 3: Grade 0 100.0 97.5
Month 3: Grade 1 0.0 0.0
Month 3: Grade 2 0.0 2.5
Month 3: Grade 3 0.0 0.0
11.Secondary Outcome
Title Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity
Hide Description Wound integrity was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Lack of wound integrity (healing, 1-3) is a sign of inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.
Time Frame Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.
Arm/Group Title DUREZOL PRED FORTE
Hide Arm/Group Description:
Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
Overall Number of Participants Analyzed 39 40
Measure Type: Number
Unit of Measure: Percentage of patients
Day 1: Grade 0 100.0 100.0
Day 1: Grade 1 0.0 0.0
Day 1: Grade 2 0.0 0.0
Day 1: Grade 3 0.0 0.0
Day 8: Grade 0 100.0 100.0
Day 8: Grade 1 0.0 0.0
Day 8: Grade 2 0.0 0.0
Day 8: Grade 3 0.0 0.0
Day 15: Grade 0 100.0 100.0
Day 15: Grade 1 0.0 0.0
Day 15: Grade 2 0.0 0.0
Day 15: Grade 3 0.0 0.0
Day 29: Grade 0 100.0 100.0
Day 29: Grade 1 0.0 0.0
Day 29: Grade 2 0.0 0.0
Day 29: Grade 3 0.0 0.0
1 Week after Last Dose: Grade 0 100.0 100.0
1 Week after Last Dose: Grade 1 0.0 0.0
1 Week after Last Dose: Grade 2 0.0 0.0
1 Week after Last Dose: Grade 3 0.0 0.0
Month 1: Grade 0 100.0 100.0
Month 1: Grade 1 0.0 0.0
Month 1: Grade 2 0.0 0.0
Month 1: Grade 3 0.0 0.0
12.Secondary Outcome
Title Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia
Hide Description Photophobia was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Photophobia (abnormal intolerance to visual perception of light) is a symptom of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.
Time Frame Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.
Arm/Group Title DUREZOL PRED FORTE
Hide Arm/Group Description:
Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
Overall Number of Participants Analyzed 39 40
Measure Type: Number
Unit of Measure: Percentage of patients
Day 1: Grade 0 71.8 60.0
Day 1: Grade 1 20.5 35.0
Day 1: Grade 2 7.7 5.0
Day 1: Grade 3 0.0 0.0
Day 8: Grade 0 89.7 87.5
Day 8: Grade 1 10.3 10.0
Day 8: Grade 2 0.0 2.5
Day 8: Grade 3 0.0 0.0
Day 15: Grade 0 97.4 95.0
Day 15: Grade 1 2.6 5.0
Day 15: Grade 2 0.0 0.0
Day 15: Grade 3 0.0 0.0
Day 29: Grade 0 97.4 92.5
Day 29: Grade 1 2.6 5.0
Day 29: Grade 2 0.0 0.0
Day 29: Grade 3 0.0 2.5
1 Week after Last Dose: Grade 0 100.0 97.5
1 Week after Last Dose: Grade 1 0.0 2.5
1 Week after Last Dose: Grade 2 0.0 0.0
1 Week after Last Dose: Grade 3 0.0 0.0
Month 3: Grade 0 100.0 100.0
Month 3: Grade 1 0.0 0.0
Month 3: Grade 2 0.0 0.0
Month 3: Grade 3 0.0 0.0
13.Secondary Outcome
Title Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation
Hide Description Lacrimation was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Excessive lacrimation (tear production and secretion, 1-3) is a symptom of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.
Time Frame Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.
Arm/Group Title DUREZOL PRED FORTE
Hide Arm/Group Description:
Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
Overall Number of Participants Analyzed 39 40
Measure Type: Number
Unit of Measure: Percentage of patients
Day 1: Grade 0 64.1 72.5
Day 1: Grade 1 30.8 22.5
Day 1: Grade 2 5.1 5.0
Day 1: Grade 3 0.0 0.0
Day 8: Grade 0 94.9 97.5
Day 8: Grade 1 5.1 2.5
Day 8: Grade 2 0.0 0.0
Day 8: Grade 3 0.0 0.0
Day 15: Grade 0 100.0 95.0
Day 15: Grade 1 0.0 5.0
Day 15: Grade 2 0.0 0.0
Day 15: Grade 3 0.0 0.0
Day 29: Grade 0 100.0 100.0
Day 29: Grade 1 0.0 0.0
Day 29: Grade 2 0.0 0.0
Day 29: Grade 3 0.0 0.0
1 Week after Last Dose: Grade 0 100.0 100.0
1 Week after Last Dose: Grade 1 0.0 0.0
1 Week after Last Dose: Grade 2 0.0 0.0
1 Week after Last Dose: Grade 3 0.0 0.0
Month 3: Grade 0 100.0 100.0
Month 3: Grade 1 0.0 0.0
Month 3: Grade 2 0.0 0.0
Month 3: Grade 3 0.0 0.0
Time Frame Adverse events were collected for the duration of the study. The safety population includes all patients who were exposed to the study drug.
Adverse Event Reporting Description An adverse event was considered to be any untoward medical occurrence in the health of a patient who was exposed to study medication, regardless of causal relationship with the study medication. Adverse events were obtained as solicited comments from the study patients and as observations by the study Investigator as outlined in the study protocol.
 
Arm/Group Title DUREZOL PRED FORTE
Hide Arm/Group Description Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
All-Cause Mortality
DUREZOL PRED FORTE
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
DUREZOL PRED FORTE
Affected / at Risk (%) Affected / at Risk (%)
Total   8/39 (20.51%)   11/40 (27.50%) 
Immune system disorders     
Cataract cortical  1 [1]  1/39 (2.56%)  0/40 (0.00%) 
Investigations     
Medical observation  1 [2]  6/39 (15.38%)  10/40 (25.00%) 
Intraocular pressure increased  1 [3]  1/39 (2.56%)  0/40 (0.00%) 
Metabolism and nutrition disorders     
Failure to thrive  1 [1]  0/39 (0.00%)  1/40 (2.50%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
[1]
Not related
[2]
Not related. Hospital admission was required for procedures involving surgery/anesthesia of certain infants.
[3]
Related
Show Other (Not Including Serious) Adverse Events 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   16/39 (41.03%)   10/40 (25.00%) 
Eye disorders     
Conjunctivitis  1  3/39 (7.69%)  0/40 (0.00%) 
Posterior capsule opacification  1  3/39 (7.69%)  0/40 (0.00%) 
Infections and infestations     
Nasopharyngitis  1  5/39 (12.82%)  2/40 (5.00%) 
Ear infection  1  3/39 (7.69%)  1/40 (2.50%) 
Sinusitis  1  2/39 (5.13%)  0/40 (0.00%) 
Investigations     
Intraocular pressure increased  1  2/39 (5.13%)  1/40 (2.50%) 
Surgical and medical procedures     
Cataract operation (non-study eye)  1  3/39 (7.69%)  6/40 (15.00%) 
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.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
Name/Title: Pam Kaur, PhD
Organization: Alcon Research, Ltd.
Phone: 1-888-451-3937
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01124045     History of Changes
Other Study ID Numbers: C-10-004
First Submitted: May 13, 2010
First Posted: May 14, 2010
Results First Submitted: April 30, 2013
Results First Posted: June 19, 2013
Last Update Posted: June 19, 2013