Trial record 1 of 6 for:
Durezol | Uveitis
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:
Alcon Research
Information provided by (Responsible Party):
Alcon Research
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
Participant Flow
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 |
---|---|---|
![]() |
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 |
Baseline Characteristics
Arm/Group Title | Durezol | Pred Forte | Total | |
---|---|---|---|---|
![]() |
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 | |
![]() |
[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%
|
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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
Name/Title: | Head, Alcon Clinical |
Organization: | Alcon Research, Ltd. |
Phone: | 1-888-451-3937 |
EMail: | medinfo@alconlabs.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |