Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Following Run-In, patients qualifying for treatment were randomized 1:1 to receive Durezol (experimental group) or Vehicle (control group) for 5 weeks.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Durezol | Experimental | 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. |
|
| Vehicle | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Difluprednate 0.05% ophthalmic emulsion | Drug | Topical ocular steroid |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, up to 4 weeks |
Not provided
Not provided
Inclusion Criteria:
Normal subjects:
OR
Dry eye patients:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Call Center at 1-888-451-3937 for Trial Locations | Fort Worth | Texas | 76134 | United States |
Of the 722 enrolled, 433 subjects did not qualify for Run-In and were exited without exposure to product. Of the 289 entering Run-In, 78 did not qualify for treatment. The 211 patients qualifying for treatment were randomized 1:1 to receive either Durezol or Vehicle.
Subjects were recruited from 25 investigative sites located within the US. Participant flow data is presented for all all subjects exposed to product.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Run-In Only | Difluprednate vehicle |
| FG001 | Durezol | Difluprednate vehicle (Run-in), followed by difluprednate 0.05% ophthalmic emulsion (treatment) |
| FG002 | Vehicle | Difluprednate vehicle (Run-In), followed by difluprednate vehicle (treatment) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Run-In Only | Difluprednate vehicle |
| BG001 | Durezol | Difluprednate vehicle (Run-in), followed by difluprednate 0.05% ophthalmic emulsion (treatment) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | All subjects randomized to treatment and receiving at least 1 administration of study medication (ITT). Mixed model repeated measure (MMRM) approach was used to handle missing data during randomized treatment period. | Posted | Mean | Standard Deviation | units on a scale | Baseline, up to 4 weeks |
|
Adverse events were collected for the duration of the study (10 months, 15 days).
The safety population includes all subjects exposed to product. Individual subject adverse events, solicited and unsolicited, were collected from time of first instillation of test article (Run-In) until the subject exited the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Run-In | Difluprednate vehicle, all patients |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment | Not related |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye pain | Eye disorders | MedDRA 13.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Alcon Clinical | Alcon Research | 1-888-451-3937 |
Not provided
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C015808 | difluprednate |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Difluprednate vehicle | Other | Inactive ingredients used as Run-In and placebo comparator |
|
| Other |
|
| Pt Decision Unrelated to Adverse Event |
|
| Protocol Violation |
|
| BG002 | Vehicle | Difluprednate vehicle (Run-In), followed by difluprednate vehicle (treatment) |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Difluprednate 0.5% ophthalmic emulsion |
| OG001 | Vehicle | Difluprednate vehicle |
|
|
| 0 |
| 289 |
| 47 |
| 289 |
| EG001 | Durezol | Difluprednate 0.05% ophthalmic emulsion | 1 | 107 | 12 | 107 |
| EG002 | Vehicle | Difluprednate vehicle | 1 | 104 | 3 | 104 |
|
| Pneumonia | Infections and infestations | MedDRA 13.0 | Systematic Assessment | Not related |
|
| Eye irritation | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| Intraocular pressure increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.