Dry Eye DiseasePhase 3SONATANCT01636206
Safety Study of Lifitegrast to Treat Dry Eye
A Phase 3 study testing Lifitegrast in people with Dry Eye Disease, run by Shire at 23 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- Lifitegrast
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 332 participants
- Where
- 23 sitesUnited States
- Study dates
- 16 Oct 2012to 3 Mar 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
SONATA Investigational Site
Artesia, California, 90701
SONATA Investigational Site
Boynton Beach, Florida, 33426
SONATA Investigational Site
Charlotte, North Carolina, 28210
SONATA Investigational Site
Chattanooga, Tennessee, 37411
SONATA Investigational Site
Cleveland, Ohio, 44115
SONATA Investigational Site
Doylestown, Pennsylvania, 18902
SONATA Investigational Site
Edgewood, Kentucky, 41017
SONATA Investigational Site
Hemet, California, 92545
SONATA Investigational Site
High Point, North Carolina, 27262
SONATA Investigational Site
Hoffman Estates, Illinois, 60169
SONATA Investigational Site
Houston, Texas, 77204
SONATA Investigational Site
Laguna Hills, California, 92653
SONATA Investigational Site
Lancaster, California, 93534
SONATA Investigational Site
Lexington, Kentucky, 40509
SONATA Investigational Site
Montebello, California, 90640
SONATA Investigational Site
Mt. Pleasant, South Carolina, 29464
SONATA Investigational Site
Parker, Colorado, 80134
SONATA Investigational Site
Pennington, New Jersey, 08534
SONATA Investigational Site
Rochester, New York, 14618
SONATA Investigational Site
Rockville Centre, New York, 11570
SONATA Investigational Site
Roswell, Georgia, 30076
SONATA Investigational Site
Stillwater, Minnesota, 55082
SONATA Investigational Site
Woodland Park, New Jersey, 07424
About this study
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)
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
- Dry Eye Disease
- Being tested
- Lifitegrast, Placebo
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifitegrastDrug
Dosage Form: Ophthalmic Solution Dosage: 5.0% Frequency: BID Duration: ~1 year
PlaceboDrug
Dosage Form: Ophthalmic Solution Dosage: placebo Frequency: BID Duration: ~1 year
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| Lifitegrast | Experimental | Active Receives: Drug: Lifitegrast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Ocular and Nonocular Treatment Emergent Adverse Events (TEAEs) for 1 Year
Measured: Day 0 to Day 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study start16 Oct 2012
- Primary completion3 Mar 2014
- Study completion3 Mar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01636206
- Sponsor's protocol ID
- 1118-DRY-400
- Acronym
- SONATA
- Status last verified
- Jun 2021
- First submitted
- 5 Jul 2012
- Last updated
- 11 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Donnenfeld ED, Karpecki PM, Majmudar PA, Nichols KK, Raychaudhuri A, Roy M, Semba CP. Safety of Lifitegrast Ophthalmic Solution 5.0% in Patients With Dry Eye Disease: A 1-Year, Multicenter, Randomized, Placebo-Controlled Study. Cornea. 2016 Jun;35(6):741-8. doi: 10.1097/ICO.0000000000000803.
PubMed 27055211
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01636206
- Acronym / sponsor ID
- SONATA / 1118-DRY-400
- Conditions
- Dry Eye Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2012 (actual)
- Primary completion
- 3 Mar 2014 (actual)
- Study completion
- 3 Mar 2014 (actual)
- First posted
- 10 Jul 2012 (estimated)
- Results
- Posted 3 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| Lifitegrast | Experimental | Drug: LifitegrastActive |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LifitegrastDosage Form: Ophthalmic Solution Dosage: 5.0% Frequency: BID Duration: ~1 year | Drug | Lifitegrast |
| PlaceboDosage Form: Ophthalmic Solution Dosage: placebo Frequency: BID Duration: ~1 year | Drug | Placebo |
Primary outcome
Number of Participants With Ocular and Nonocular Treatment Emergent Adverse Events (TEAEs) for 1 Year
Time frame: Day 0 to Day 360
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27055211Donnenfeld ED, Karpecki PM, Majmudar PA, Nichols KK, Raychaudhuri A, Roy M, Semba CP. Safety of Lifitegrast Ophthalmic Solution 5.0% in Patients With Dry Eye Disease: A 1-Year, Multicenter, Randomized, Placebo-Controlled Study. Cornea. 2016 Jun;35(6):741-8. doi: 10.1097/ICO.0000000000000803.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lifitegrast in people with Dry Eye Disease, run by Shire at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Ocular and Nonocular Treatment Emergent Adverse Events (TEAEs) for 1 Year (time frame: Day 0 to Day 360). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01636206, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.