Back to resultsEvaluation of Anti-Inflammatory Treatment in Dry Eye Patients
Primary Purpose
Dry Eye Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Difluprednate 0.05% ophthalmic emulsion
Difluprednate vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Disease focused on measuring Dry eye, ocular discomfort
Eligibility Criteria
Inclusion Criteria:
Normal subjects:
- No known history of dry eye disease.
- Non-contact lens wearer.
- No current use of artificial tears or any other dry eye treatment.
OR
Dry eye patients:
- At least a 6 month history of dry eye.
- Non-contact lens wearer.
- Uses artificial tears.
- Experiences persistent ocular discomfort.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- The presence of any acute infectious or non-infectious ocular conditions in either eye within 1 month of Visit 1.
- Severe Sjogren's Syndrome.
- Lid function abnormalities.
- Use of steroids, tetracycline, doxycycline, etc., within 30 days of Visit 1.
- History of corneal surgery including refractive surgeries.
- History of glaucoma or ocular hypertension
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
- Contact Alcon Call Center at 1-888-451-3937 for Trial Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Durezol
Vehicle
Arm Description
Difluprednate 0.05% ophthalmic emulsion, 1 drop to the study eye 2 times a day for 4 weeks, followed by 1 drop to the study eye once daily for 1 week to allow for tapering of the steroid exposure.
Difluprednate vehicle, 1 drop to the study eye 2 times a day for 4 weeks, followed by 1 drop to the study eye once daily for 1 week.
Outcomes
Primary Outcome Measures
Mean Change From Baseline (Week 0) in Visual Analog Scale (VAS) Global Ocular Discomfort Score Over 4 Weeks
A Visual Analog Scale (VAS) was used by the subject to assess ocular discomfort, both frequency and severity, at baseline (pre-treatment) and weekly thereafter for 4 additional weeks. Each scale was 100 millimeters (mm) in length. The VAS score was calculated by measuring the length in mm from the start of the line to the intersection point of the vertical mark made by the subject. The Global Ocular Discomfort Score is a composite of the two VAS scores, ranging from 0 (very mildly) to 100 (very severely uncomfortable).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01276223
Brief Title
Evaluation of Anti-Inflammatory Treatment in Dry Eye Patients
Official Title
A Multi-Center, Randomized, Double-Masked Evaluation of Anti-Inflammatory Treatment in Patients With Dry Eye
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to determine if difluprednate ophthalmic emulsion is effective in reducing the ocular symptoms of dry eye disease, as measured by a global Visual Analog Scale (VAS) discomfort score.
Detailed Description
Following Run-In, patients qualifying for treatment were randomized 1:1 to receive Durezol (experimental group) or Vehicle (control group) for 5 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease
Keywords
Dry eye, ocular discomfort
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
722 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Durezol
Arm Type
Experimental
Arm Description
Difluprednate 0.05% ophthalmic emulsion, 1 drop to the study eye 2 times a day for 4 weeks, followed by 1 drop to the study eye once daily for 1 week to allow for tapering of the steroid exposure.
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Difluprednate vehicle, 1 drop to the study eye 2 times a day for 4 weeks, followed by 1 drop to the study eye once daily for 1 week.
Intervention Type
Drug
Intervention Name(s)
Difluprednate 0.05% ophthalmic emulsion
Other Intervention Name(s)
DUREZOL™
Intervention Description
Topical ocular steroid
Intervention Type
Other
Intervention Name(s)
Difluprednate vehicle
Intervention Description
Inactive ingredients used as Run-In and placebo comparator
Primary Outcome Measure Information:
Title
Mean Change From Baseline (Week 0) in Visual Analog Scale (VAS) Global Ocular Discomfort Score Over 4 Weeks
Description
A Visual Analog Scale (VAS) was used by the subject to assess ocular discomfort, both frequency and severity, at baseline (pre-treatment) and weekly thereafter for 4 additional weeks. Each scale was 100 millimeters (mm) in length. The VAS score was calculated by measuring the length in mm from the start of the line to the intersection point of the vertical mark made by the subject. The Global Ocular Discomfort Score is a composite of the two VAS scores, ranging from 0 (very mildly) to 100 (very severely uncomfortable).
Time Frame
Baseline, up to 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Normal subjects:
No known history of dry eye disease.
Non-contact lens wearer.
No current use of artificial tears or any other dry eye treatment.
OR
Dry eye patients:
At least a 6 month history of dry eye.
Non-contact lens wearer.
Uses artificial tears.
Experiences persistent ocular discomfort.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
The presence of any acute infectious or non-infectious ocular conditions in either eye within 1 month of Visit 1.
Severe Sjogren's Syndrome.
Lid function abnormalities.
Use of steroids, tetracycline, doxycycline, etc., within 30 days of Visit 1.
History of corneal surgery including refractive surgeries.
History of glaucoma or ocular hypertension
Other protocol-defined exclusion criteria may apply.
Facility Information:
Facility Name
Contact Alcon Call Center at 1-888-451-3937 for Trial Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Anti-Inflammatory Treatment in Dry Eye Patients
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