Trials / Completed
CompletedNCT01636206
Safety Study of Lifitegrast to Treat Dry Eye
A Phase 3, Multicenter, Randomized, Double-Masked and Placebo-Controlled Study Evaluating the Safety of a 5.0% Concentration of Lifitegrast Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye (SONATA)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 332 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to evaluate the safety of lifitegrast ophthalmic solution compared to placebo in the treatment of dry eye as assessed by ocular and non-ocular adverse events when administered BID for approximately 1 year.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lifitegrast | Dosage Form: Ophthalmic Solution Dosage: 5.0% Frequency: BID Duration: \~1 year |
| DRUG | Placebo | Dosage Form: Ophthalmic Solution Dosage: placebo Frequency: BID Duration: \~1 year |
Timeline
- Start date
- 2012-10-16
- Primary completion
- 2014-03-03
- Completion
- 2014-03-03
- First posted
- 2012-07-10
- Last updated
- 2021-06-11
- Results posted
- 2016-10-03
Locations
23 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01636206. Inclusion in this directory is not an endorsement.