Trials / Completed
CompletedNCT01276223
Evaluation of Anti-Inflammatory Treatment in Dry Eye Patients
A Multi-Center, Randomized, Double-Masked Evaluation of Anti-Inflammatory Treatment in Patients With Dry Eye
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 722 (actual)
- Sponsor
- Alcon Research · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Difluprednate 0.05% ophthalmic emulsion | Topical ocular steroid |
| OTHER | Difluprednate vehicle | Inactive ingredients used as Run-In and placebo comparator |
Timeline
- Start date
- 2011-02-01
- Primary completion
- 2012-01-01
- Completion
- 2012-01-01
- First posted
- 2011-01-13
- Last updated
- 2013-03-11
- Results posted
- 2013-03-11
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01276223. Inclusion in this directory is not an endorsement.