Safety Study of Lifitegrast to Treat Dry Eye
Public ClinicalTrials.gov record NCT01636206. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01636206
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 332 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 15, 2012
- Primary completion
- Mar 2, 2014
- Completion
- Mar 2, 2014
- Last update posted
- Jun 10, 2021
2012 – 2014
United States locations
- U.S. sites
- 23
- U.S. states
- 15
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| SONATA Investigational Site | Artesia | California | 90701 | — |
| SONATA Investigational Site | Hemet | California | 92545 | — |
| SONATA Investigational Site | Laguna Hills | California | 92653 | — |
| SONATA Investigational Site | Lancaster | California | 93534 | — |
| SONATA Investigational Site | Montebello | California | 90640 | — |
| SONATA Investigational Site | Parker | Colorado | 80134 | — |
| SONATA Investigational Site | Boynton Beach | Florida | 33426 | — |
| SONATA Investigational Site | Roswell | Georgia | 30076 | — |
| SONATA Investigational Site | Hoffman Estates | Illinois | 60169 | — |
| SONATA Investigational Site | Edgewood | Kentucky | 41017 | — |
| SONATA Investigational Site | Lexington | Kentucky | 40509 | — |
| SONATA Investigational Site | Stillwater | Minnesota | 55082 | — |
| SONATA Investigational Site | Pennington | New Jersey | 08534 | — |
| SONATA Investigational Site | Woodland Park | New Jersey | 07424 | — |
| SONATA Investigational Site | Rochester | New York | 14618 | — |
| SONATA Investigational Site | Rockville Centre | New York | 11570 | — |
| SONATA Investigational Site | Charlotte | North Carolina | 28210 | — |
| SONATA Investigational Site | High Point | North Carolina | 27262 | — |
| SONATA Investigational Site | Cleveland | Ohio | 44115 | — |
| SONATA Investigational Site | Doylestown | Pennsylvania | 18902 | — |
| SONATA Investigational Site | Mt. Pleasant | South Carolina | 29464 | — |
| SONATA Investigational Site | Chattanooga | Tennessee | 37411 | — |
| SONATA Investigational Site | Houston | Texas | 77204 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01636206, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 10, 2021 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01636206 live on ClinicalTrials.gov.