Dry EyePhase 4NCT03952481
Effect of Lifitegrast 5% on Tear Film Markers
A Phase 4 study testing Lifitegrast 5% Ophthalmic Solution in people with Dry Eye and Dry Eye Syndromes, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this study is to assess the duration of time (in weeks) for improvement in objective dry eye markers for people who are placed on lifitegrast 0.5% (Xiidra®), an FDA-approved therapy for dry eyes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye, Dry Eye Syndromes, Dry Eyes Chronic
- What is being tested?
- Lifitegrast 5% Ophthalmic Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 31 Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Signs or symptoms of Dry Eye Disease
- 18 years or older
- Abnormal MMP9 (positive as read by 2 blinded investigators with both in agreement) and/or Abnormal tear osmolarity (greater than or equal to 308 or an inter-eye difference >=8 mOsm/mL)
Who cannot join
- Active eye infection. Patients with blepharitis may be enrolled.
- Any eye drop that was instilled within 2 hours of the Baseline eye exam
- Current contact lens wearer. Subjects who have not worn contact lenses 30 days prior to baseline and have no intention to wear CLs during the study duration may enroll.
- History of ocular herpes simplex
- Active episcleritis, scleritis, iritis or uveitis
- Active keratitis secondary to any etiology other than dry eyes
Show all 13Show fewer
- History of refractive surgery (LASIK or PRK) or penetrating corneal transplant (PK)
- Uses eye drops (ex. glaucoma or allergy drops) for indications other than dry eyes
- Active allergic conjunctivitis
- Current use of punctal plugs or anticipation of use during the study
- Use of topical ophthalmic steroids within 14 days of the Baseline Visit or anticipated use during the study
- Use of lifitegrast 5% or Restasis within 30 Days of the Baseline Visit.
- Allergy to lifitegrast 5%
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Ophthalmology
New York, New York, 10021
About this study
Official title: Improvement in Markers of Tear Film Instability After Initiation of Lifitegrast 5% Ophthalmic Solution: A Prospective Interventional Study
The purpose of this study is to assess the duration of time (in weeks) for improvement in objective dry eye markers for people who are placed on lifitegrast 0.5% (Xiidra®), an FDA-approved therapy for dry eyes.
- Conditions
- Dry Eye, Dry Eye Syndromes, Dry Eyes Chronic
- Being tested
- Lifitegrast 5% Ophthalmic Solution
- Keywords
- Dry Eye, Lifitegrast, Xiidra
- 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.
Lifitegrast 5% Ophthalmic SolutionDrug
Participants will received lifitegrast 5% ophthalmic solution twice a day in each eye for approximately 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Lifitegrast 5% Ophthalmic Solution | Experimental | Participants will received lifitegrast 5% ophthalmic solution twice a day in each eye for approximately 4 weeks. Receives: Drug: Lifitegrast 5% Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in proportion of subjects demonstrating improved tear film osmolarity
Improved tear film osmolarity will be defined as an osmolarity reading of less than or equal to 308 mOsm/L or an inter-eye difference osmolarity reading of less than or equal to 8 mOsm/L.
Measured: Baseline, Weeks 1, 2, 3 and 4
Secondary outcomes (4)
The proportion of subjects demonstrating normal Matrix Metallopeptidase 9 (MMP9).
Normal MMP9 is determined by 2 blinded investigators who each independently read the test result as negative and who are in agreement.
Measured: Week 4
The proportion of subjects demonstrating normal Tear Break-Up Time (TBUT).
Greater than 10 seconds is normal, 5 to 10 seconds is marginal, and less than 5 seconds is low.
Measured: Week 4
The proportion of subjects demonstrating normal corneal fluorescein staining.
Corneal staining will be assessed using the National Eye Institute Scale for corneal staining.
Measured: Week 4
The proportion of subjects demonstrating improvement in their symptoms as measured by the modified SANDE Questionnaire.
A modified SANDE Questionnaire uses a visual analogue scale at the Baseline Visit to measure the frequency and severity of subject's dry eyes symptoms. Subsequent visit Questionnaires will use a visual analogue scale to measure the change in symptoms compare to the results of the prior visit.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start1 Mar 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Why it stopped: COVID restrictions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Christopher Starr, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03952481
- Sponsor's protocol ID
- 1804019156
- Status last verified
- Feb 2021
- First submitted
- 10 May 2019
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement in Markers of Tear Film Instability After Initiation of Lifitegrast 5% Ophthalmic Solution: A Prospective Interventional Study
- ClinicalTrials.gov ID
- NCT03952481
- Acronym / sponsor ID
- 1804019156
- Conditions
- Dry Eye, Dry Eye Syndromes, Dry Eyes Chronic
- Keywords
- Dry Eye, Lifitegrast, Xiidra
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID restrictions
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 16 May 2019 (actual)
- Results
- Not posted in the source record
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 this study is to assess the duration of time (in weeks) for improvement in objective dry eye markers for people who are placed on lifitegrast 0.5% (Xiidra®), an FDA-approved therapy for dry eyes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifitegrast 5% Ophthalmic Solution | Experimental | Drug: Lifitegrast 5% Ophthalmic SolutionParticipants will received lifitegrast 5% ophthalmic solution twice a day in each eye for approximately 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signs or symptoms of Dry Eye Disease
- 18 years or older
- Abnormal MMP9 (positive as read by 2 blinded investigators with both in agreement) and/or Abnormal tear osmolarity (greater than or equal to 308 or an inter-eye difference >=8 mOsm/mL)
Key exclusion criteria (13 listed)
- Active eye infection. Patients with blepharitis may be enrolled.
- Any eye drop that was instilled within 2 hours of the Baseline eye exam
- Current contact lens wearer. Subjects who have not worn contact lenses 30 days prior to baseline and have no intention to wear CLs during the study duration may enroll.
- History of ocular herpes simplex
- Active episcleritis, scleritis, iritis or uveitis
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 |
|---|---|---|
| Lifitegrast 5% Ophthalmic SolutionParticipants will received lifitegrast 5% ophthalmic solution twice a day in each eye for approximately 4 weeks. | Drug | Lifitegrast 5% Ophthalmic Solution |
Primary outcome
The change in proportion of subjects demonstrating improved tear film osmolarity
Time frame: Baseline, Weeks 1, 2, 3 and 4
Improved tear film osmolarity will be defined as an osmolarity reading of less than or equal to 308 mOsm/L or an inter-eye difference osmolarity reading of less than or equal to 8 mOsm/L.
4 secondary outcomes
The proportion of subjects demonstrating normal Matrix Metallopeptidase 9 (MMP9).
Time frame: Week 4
The proportion of subjects demonstrating normal Tear Break-Up Time (TBUT).
Time frame: Week 4
The proportion of subjects demonstrating normal corneal fluorescein staining.
Time frame: Week 4
The proportion of subjects demonstrating improvement in their symptoms as measured by the modified SANDE Questionnaire.
Time frame: Week 4
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Christopher Starr, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lifitegrast 5% Ophthalmic Solution in people with Dry Eye and Dry Eye Syndromes, run by Weill Medical College of Cornell University at 1 site 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 3 inclusion and 13 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: withdrawn, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
The change in proportion of subjects demonstrating improved tear film osmolarity (time frame: Baseline, Weeks 1, 2, 3 and 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Feb 2021.