Safety Study of Lifitegrast to Treat Dry Eye (SONATA)
This study has been completed.
Information provided by (Responsible Party):
First received: July 5, 2012
Last updated: May 7, 2014
Last verified: May 2014
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.
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||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)
Primary Outcome Measures:
- The Safety of Lifitegrast as assessed by ocular and Non-Ocular AEs [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Ocular Safety Measures [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2014 (Final data collection date for primary outcome measure)
Placebo Comparator: Placebo
Dosage Form: Ophthalmic Solution Dosage: placebo Frequency: BID Duration: ~1 year
Dosage Form: Ophthalmic Solution Dosage: 5.0% Frequency: BID Duration: ~1 year
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Willing and able to read, sign and date the informed consent and HIPAA documents
- Willing and able to comply with all study procedures
- Be at least 18 years of age
- Patient-reported history of dry eye in both eyes
- A negative urine pregnancy test if female of childbearing potential and must use adequate birth control throughout the study period
- Any ocular condition that, in the opinion of the Investigator, could affect study parameters including, but not limited to, active ocular infection, ocular inflammation, glaucoma, and/or diabetic retinopathy
- Unwilling to avoid wearing contact lenses for 24h prior to Visit 1 and for some duration during the study
- Any blood donation or significant loss of blood within 56 days of Visit 1
- Any history of immunodeficiency disorder, positive HIV, hepatitis B, C, or evidence of acute active hepatitis A (anti-HAV IgM), or organ or bone marrow transplant.
- Use of any prohibited medications during the appropriate pre-study washout period and at any time during the study unless otherwise specified
- Any significant illness that could interfere with study parameters
- History of laser‑assisted in situ keratomileusis (LASIK) or similar type of corneal refractive surgery within 12 months prior to Visit 1, and/or any other ocular surgical procedure within 12 months prior to Visit 1; or any scheduled ocular surgical procedure during the study period.
- Known history of alcohol and/or drug abuse
- Subjects with Dry eye secondary to scarring or destruction of conjunctival goblet cells (as with Vitamin A deficiency)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01636206
||Charles Semba, MD
||SARcode Bioscience, Inc.
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 5, 2012
||May 7, 2014
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 22, 2014
Dry Eye Syndromes
Lacrimal Apparatus Diseases