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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01124045
First received: May 13, 2010
Last updated: April 30, 2013
Last verified: April 2013
Results First Received: April 30, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Cataracts
Inflammation
Interventions: Drug: Difluprednate ophthalmic emulsion, 0.05%
Drug: Prednisolone acetate ophthalmic suspension, 1.0%

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were screened and recruited from 17 study centers located within the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
DUREZOL 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
PRED FORTE 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

Participant Flow:   Overall Study
    DUREZOL     PRED FORTE  
STARTED     39     40  
COMPLETED     39     37  
NOT COMPLETED     0     3  
Lost to Follow-up                 0                 1  
Physician Decision                 0                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline characteristics are presented for all patients who were exposed to the study drug.

Reporting Groups
  Description
DUREZOL 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
PRED FORTE 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 Total of all reporting groups

Baseline Measures
    DUREZOL     PRED FORTE     Total  
Number of Participants  
[units: participants]
  39     40     79  
Age, Customized  
[units: 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  
Gender  
[units: participants]
     
Female     22     20     42  
Male     17     20     37  
Region of Enrollment  
[units: participants]
     
United States     39     40     79  



  Outcome Measures
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1.  Primary:   Percentage of Patients With an Anterior Cell Grade of 0 (no Cells) at Day 15 ± 2 Days   [ Time Frame: Day 15 ± 2 days ]

2.  Secondary:   Global Assessment Score of Postoperative Inflammation by Visit   [ 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 ]

3.  Secondary:   Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade   [ 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 ]

4.  Secondary:   Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade   [ 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 ]

5.  Secondary:   Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity   [ 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 ]

6.  Secondary:   Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection   [ 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 ]

7.  Secondary:   Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection   [ 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 ]

8.  Secondary:   Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis   [ 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 ]

9.  Secondary:   Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon   [ 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 ]

10.  Secondary:   Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis   [ 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 ]

11.  Secondary:   Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity   [ 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 ]

12.  Secondary:   Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia   [ 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 ]

13.  Secondary:   Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation   [ 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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pam Kaur, PhD
Organization: Alcon Research, Ltd.
phone: 1-888-451-3937
e-mail: alcon.medinfo@alcon.com


No publications provided


Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01124045     History of Changes
Other Study ID Numbers: C-10-004
Study First Received: May 13, 2010
Results First Received: April 30, 2013
Last Updated: April 30, 2013
Health Authority: United States: Food and Drug Administration