Trials / Completed
CompletedNCT01338610
ESBA105 in Patients With Severe Dry Eye
Evaluation of ESBA105 in the Persistent Relief of Ocular Discomfort in Patients With Severe Dry Eye
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 334 (actual)
- Sponsor
- Alcon Research · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study was to evaluate the efficacy of ESBA105 over vehicle in reducing the ocular symptoms of dry eye disease, as measured by a mean global Visual Analog Scale (VAS) discomfort score.
Detailed description
Following Run-In, patients qualifying for treatment were randomized 2:1 to receive ESBA105 (experimental group) or Vehicle (control group) for 4 weeks. Patients not qualifying for treatment (based on global VAS discomfort score), were discontinued from the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ESBA105 ophthalmic solution | |
| OTHER | ESBA105 vehicle | Inactive ingredients used as Run-In and placebo comparator |
Timeline
- Start date
- 2011-06-01
- Primary completion
- 2012-02-01
- Completion
- 2012-02-01
- First posted
- 2011-04-19
- Last updated
- 2013-04-19
- Results posted
- 2013-04-19
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01338610. Inclusion in this directory is not an endorsement.